FDA Registration
Active
🇺🇸 United States
BRACE ALIGN
Reg #: 3013002868
·
FEI: 3013002868
·
Expires 2026
Products
24
Proprietary Names
272
Establishment Types
2
Classifications
24
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Registration Details
- Registration Name
- BRACE ALIGN
- Registration Number
- 3013002868
- FEI Number
- 3013002868
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 128 Harrison Ln
- City
- Soddy Daisy
- State
- TN
- ZIP
- 37379
- Country
- US
Owner / Operator
- Firm Name
- Brace Align
- Operator Number
- 10052555
- Address
- 128 Harrison Lane
- City
- Soddy Daisy
- State
- TN
- Postal Code
- 37379
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2024-02-06 |
| Joint, Knee, External Limb Component | ISY | Class 1 | Physical Medicine | No | 2026-04-27 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2016-08-15 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2016-08-19 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2021-01-15 |
| Orthosis, Thoracic | IPT | Class 1 | Physical Medicine | No | 2024-02-06 |
| Mattress, Air Flotation, Alternating Pressure | FNM | Class 2 | General Hospital | No | 2021-05-12 |
| Device, Prosthesis Alignment | IQO | Class 1 | Physical Medicine | No | 2025-09-12 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2021-01-15 |
| Cushion, Wheelchair | IMP | Class 1 | Physical Medicine | No | 2026-04-28 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2024-02-06 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2024-02-06 |
| Apparatus, Traction, Non-Powered | HST | Class 1 | Orthopedic | No | 2021-05-12 |
| Orthosis, Foot Drop | OHI | Class 1 | Physical Medicine | No | 2026-04-28 |
| Component, External, Limb, Ankle/Foot | ISH | Class 1 | Physical Medicine | No | 2025-09-11 |
| Joint, Hip, External Brace | ITS | Class 1 | Physical Medicine | No | 2026-04-28 |
| Band Or Belt, Pelvic Support | ISR | Class 1 | Physical Medicine | No | 2024-02-06 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2024-02-06 |
| Pack, Hot Or Cold, Water Circulating | ILO | Class 2 | Physical Medicine | No | 2021-05-12 |
| Joint, Hip, External Limb Component | ISL | Class 1 | Physical Medicine | No | 2026-04-28 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2025-06-23 |
| Support, Hernia | EXN | Class 1 | Gastroenterology, Urology | No | 2024-02-06 |
| Cover, Limb | IPM | Class 1 | Physical Medicine | No | 2024-02-06 |
| Pad, Heating, Powered | IRT | Class 2 | Physical Medicine | No | 2021-01-15 |
Proprietary Names
Brace Direct Deluxe Shoulder Immobilizer - ARS268
Brace Direct Arm Sling - ARS270
Brace Direct Foam Arm Sling Shoulder Immobilizer - ARS196-2
Brace Align Arm Sling and Swathe - ARS263
Brace Direct Pediatric Arm Sling - ARS265
Brace Direct Standard Shoulder Immobilizer Sling - ARS269
Brace Direct Immobilizer with Adbuctor - ARS167
Brace Direct Ossur Padded Strap Shoulder Immobilizer Sling - ARS494
Breg T Scope Premier Post-Op Knee Brace with BridgeTech Incision Pad by Brace Direct - KNB367-088
Breg T Scope BridgeTech Incision Pad Only by Brace Direct - KNB367-73621
Brace Align EasyStrap Unloader Knee Brace Straps 427 - ACS443
Breg T Scope Set of 4 Y-Tabs by Brace Direct - KNB367-00002
Brace Align Replacement Apex ACL Straps 428 - ACS444
Brace Direct Anti-Slip Strap for Knee Brace - KNW214
Breg T Scope Full Pad Replacement Kit by Brace Direct - KNB367-00015
Medical Lumbosacral Orthosis Back Brace by Brace Direct - BKB379
Breg Essentials Lumbar 631 Brace by Brace Direct - VP10631
Brace Direct BakTec 627 LSO Back Brace - BKB430
Brace Align Back Brace Extension Belt - BKB123-2
Brace Direct Lower Back Support Brace - BKB117
Brace Direct Rehabilitator LSO Back Brace - BKB120
Brace Align GlideFit SI Extension Panel - BKB434
Brace Align Adjustable LSO Back Brace - BKB121
Brace Align Core TLSO LSO Side Stays Side Panels - ACS435
Brace Direct LSO Back Brace for Lower Back Pain - BKB307
Brace Align VertebrAlign LSO Back Brace - BKB154
Brace Align VertebrAlign LSO Back Brace - BKB155
Brace Align Core Pro Plus LSO - BKB498
Brace Direct Core Lumbar Support Brace - BKB464
Brace Align VertebrAlign LSO II Medical Back Brace - BKB248
Brace Direct BakTec 650 LSO High Back Brace - BKB432
Brace Align VertebrAlign 51 LSO Back Brace - BKB499
Brace Direct Lower Back Support Brace - BKB287
Brace Align VertebrAlign LSO Lower Back Brace for Pain - BKB355
Brace Align GlideFit SI Belt - BKB420
Brace Direct Low Profile Lumbar Back Support Brace - BKB266
Brace Direct Back Brace Extension Belt - BKB122-2
Brace Align Core Pro LSO - BKB426
Brace Direct Contoured LSO Brace with Adjustable Lumbar Support - BKB281
Brace Align Rigid Anterior Panel Accessory for LSO - ACS470
Breg Essentials Lumbar 627 Brace by Brace Direct - VP10627
Breg Essentials Lumbar 637 Brace by Brace Direct - VP10637
Brace Align Ultra Light Air Short Full Shell Walking Boot - BTS278
Brace Align Carpal Tunnel Wrist Brace - WRB113
Brace Direct Cold Gel Tennis Elbow Brace - ARB199
Brace Align 90 Degree Night Splint - FTB257
Brace Direct 90 Degree Comfort Padded Night Splint - FTB-CL63-105
Brace Direct Immobilizer with Abductor - ARS167
Brace Direct Short Full Shell Walking Boot - BTS207
Brace Direct Pediatric Wrist Brace - WRB310
CMC Osteoarthritis Thumb Ring Brace - Bort by Brace Direct - WRW105-100
Brace Direct Wide Air Cam Fracture Boot Short - BTS222
Brace Direct Post Op Shoe - POS110
Brace Align PrecisionMotion ROM Wrist Brace - WRB436
Brace Direct Lycra Wrist Brace - WRB228
Brace Align Plantar Fasciitis Air Wrap - FTB259
Brace Align Air Cam Walker Fracture Short Boot - BTS104
VersaFit Wrist Brace - Breg by Brace Direct - WRB100639
Brace Direct Rom Cam Walker Tall - BTS-AD31
Brace Direct Carpal Tunnel Wrist Brace Night Splint - WRB303
Brace Align FlexRecover Hinged ROM Elbow Brace - EBB429
Brace Direct Plantar Fasciitis Posterior Night Splint - FTB133
Brace Direct Plantar Fasciitis Day Splint - FTW201
Brace Direct Deluxe Post Op Shoe - POS294
Brace Direct Mini Thumb Spica Splint - WRB166
Brace Align Wrist and Thumb Spica - WRB115
Brace Align ActivAir Walking Boot (Short) - BTS440
Brace Direct Tall Air Cam Walker Boot - BTS315
Brace Direct Pediatric Post Op Shoe - POST276
Brace Align ActivAir Walking Boot (Tall) - BTS441
Vectra Pro Walker Boot - Breg by Brace Direct - BTS469
Brace Align Stabilizing ROM Hinged Elbow Brace - EBB135
Brace Direct Plantar Fasciitis Pneumatic Foot Strap - PFD210
Brace Direct Lightweight Medical Full Shell Walking Boot with Air Pump - BTS297
Brace Direct Wide Air Cam Fracture Boot Tall - BTS219
Brace Direct Lightweight Medical Full Shell Walking Boot - BTS295
Brace Direct Wrist Splint with Thumb Spica - WRW111
Brace Direct Wide Cam Walker Fracture Boot Tall - BTS221
Universal Wrist Lacer Support Brace - Breg by Brace Direct - WRB380
Brace Direct Air Cam Fracture Boot - BTS-AD320
Brace Align Deluxe Post Op Shoe - POS223
Brace Align Cam Walker Fracture Boot Short - BTS119
Brace Align Pediatric Wrist Brace - WRB299
Brace Direct Plantar Fasciitis Premium Night Splint - FTB328
Brace Direct Wrist Support Brace - WRB106
Brace Direct Compression Brace for Tennis Elbow - KSP204
Brace Direct ROM Sprained Wrist Brace - WRB217
Brace Direct CAM Walker Fracture Boot Short - BTS116
Brace Direct Air Cam Walker Fracture Short Boot - BTS105
Brace Direct Pro Boxer Metacarpal Hand Fracture Splint - HNB463
Brace Direct CAM Walker Fracture Tall Boot - BTS103
Brace Align Air Cam Walker Fracture Boot Tall - BTS108
Brace Align Hybrid Night Splint - FTB158
Brace Direct ROM Post-Op Rehabilitation Elbow Brace - EBB136
Brace Direct Womens Short Air Walker Boot - BTS296
Brace Align Adjustable Night Splint - FTB255
Brace Align Deluxe Shoulder Brace - ARB-AD5100-E
Brace Direct Hybrid Night Splint - FTB162
Brace Direct 90 Degree Night Splint - FTB132
Brace Direct Pediatric Wrist Splint - WRB274
Brace Direct ColorPop Wrist Kids Brace - WRB418
Brace Align Cam Walker Fracture Boot Tall - BTS107
Brace Align Childrens Post Op Shoe - POS313
Brace Align Dorsal Night Splint - NTS264
Brace Direct Wide Cam Walker Fracture Boot Short - BTS220
Brace Align 90 Degree Night Splint - FTB361
Brace Direct Adjustable Posterior Night Splint - FTB254
Brace Direct Short Air Cam Walker Boot - BTS357
Sport Elbow Compression Band - Bort by Brace Direct - ARB022500SP
Brace Align StrideElite Leaf Spring AFO - FTB419
Brace Direct Dorsal Night Splint - NTS109
Brace Align Mini Thumb Spica Splint - WRW258
Brace Direct ROM Post Op Elbow Brace - EBB239
Brace Direct Air Cam Fracture Boot Tall - BTS118
Brace Direct Pediatric Wrist Brace - WRB209
Knit Elbow Compression Brace - Bort by Brace Direct - ARB122600
Brace Direct Premium Dorsal Night Splint - FTB241
Brace Direct Pediatric Walker Fracture Boot - BTS249
Brace Direct Digital Cervical Traction Unit with Massage/Heat/TENS - CTU377
Brace Direct Digital Cervical Traction Unit with Massage/Heat/TENS - CTU253
Brace Direct Digital Lumbar Traction Unit - LTU320
Brace Direct Neck Massager with Heat/Traction/TENS - CTU229
Brace Direct JumpStim TENS Muscle Stimulator - MTU458
Brace Direct Relief Pulse 5 TENS Unit by Ultima 5 - TNU456
Brace Direct OTC TENS Massager Unit by Ultima - TNU459
Brace Direct Digital Lumbar Traction - LTU251
Renewed Brace Direct Digital Cervical Traction Unit - UCTU348
Brace Direct Relief Pulse TENS Unit by Ultima 20 - TNU457
Brace Direct Digital Lumbar Traction Unit with Heat & Massage - LTU471
Brace Direct Digital Cervical Traction Unit - CTU348
Brace Align TLSO Thoracic Back Support Brace - BKB153
Brace Align ComfortCore TLSO - BKB427
Brace Direct Full Back Support Soft TLSO - BKB330
Brace Align VertebrAlign TLSO II Thoracic Medical Back Brace - BKB250
Brace Align TLSO Thoracic Back Support Brace - BKB271
Brace Align TLSO Thoracic Back Support Brace - BKB362
Brace Align TLSO Upper Back Support Brace - BKB169
Brace Align Core TLSO LSO Side Stays for Back Braces - ACS435
Brace Align Core VertebrAlign TLSO LSO Side Stays - ACS442
Brace Align TLSO Full Back Brace - BKB312
Brace Align Postural Correcting TLSO Back Brace - BKB175
Brace Direct Posture Back Brace TLSO - BKB170
Brace Direct Alternating Pressure Mattress - ACS225
Brace Align VertebrAlign TLSO LSO Side Stays - ACS442
Brace Direct Cervical Air Traction Collar - CRC289
Brace Direct Cervical Air Traction 2 Collar - CRC288
Ottobock Minerva Orthosis Cervical Thoracic Brace By Brace Direct - BKB364
Brace Align Cervical Neck Traction Collar - CNC401
Brace Direct Cervical Neck Traction Collar - CNC193
Brace Direct Soft Cervical Collar - CRC321
Renewed Brace Direct Pressure Modulating Wheelchair Cushion - UACS227
Brace Direct Alternating Pressure Wheelchair Cushion - ACS227
Brace Direct Cold Compression Knee Wrap - CTY178-2
Brace Direct Cryotherapy Air Pump Ankle Foot Wrap - CTY181-2
Brace Direct Knee Ice Pack Wrap with Compression - CTY282
Brace Direct Shoulder Ice Pack with Compression - CTY179
Brace Direct Ice Pack for Back with Compression - CTY180
Brace Direct Wrist Ice Pack Wrap with Compression - CTY183
Brace Direct Reusable Refreezable Extra Large Plastic Ice Cubes - ACS409
Brace Direct Ice Pack for Thigh with Compression - CTY182
Brace Direct Elbow Ice Wrap with Compression - CTY184-2
Brace Direct Reusable Refreezable Extra Large Plastic Ice Cubes - ACS381
Brace Direct Ice Pack for Knee Pain & Swelling - ACS168
Brace Direct Calf Ice Pack Wrap with Compression - CTY195
Brace Direct Back Brace Hot or Cold Therapy Pack - ACS447
Brace Direct Cryotherapy Air Pump Hip Wrap - CTY185-2
Brace Direct Back Ice Pack Insert for Back Braces - ACS236
Brace Direct Ankle & Foot Gel Ice Pack - ACS272
Brace Direct Air Cushion Ankle Brace - AKB172
Brace Direct In-Motion Ankle Brace - AKB191
Brace Direct Recovery Ankle Brace - AKB215
Brace Direct Air Stirrup Ankle Brace - AKB172-2
Brace Align Semi-Rigid Active Ankle Brace - AKB260
Breg by Brace Direct Ultra CTS Ankle Brace - BTS314
Brace Direct Semi-Rigid Active Ankle Brace - AKB134
Brace Direct Lace Up Ankle Brace - AKB177
Brace Direct Easy Lace Up Ankle Brace - AKB309
Elite Rehabilitator Varus/Valgus Ankle Control Strap - ACS286
Brace Direct Gel Air Ankle Brace - AKB173-2
Brace Direct Sport Ankle Compression Sleeve - AKB-CL67-200
Brace Align Ankle Brace - AKB176
TaloStabil Sport Ankle Compression Brace with Figure 8 Strap - Bort by Brace Direct - ASK054100SP
Brace Direct Cervical Traction Device & Neck Stretcher - CTU411
Brace Direct Cervical Traction Unit Comfort Accessory Kit - ACS415
Renewed Brace Direct Cervical Air Traction Collar - UCNC193
Renewed Brace Direct Cervical Traction and Stretch Unit - UCTU138
Brace Direct Cervical Traction Unit - CTU174
Therahab Cervical Neck Traction Unit - CTU366
Brace Direct Cervical Neck Traction Unit - CTU138-2
Brace Align Portable Cervical Neck Traction Device - CTU203
Brace Direct Digital Cervical Traction Unit - CTU418
Brace Align Portable Cervical Traction Unit - CTU161
Renewed Brace Direct Cervical Neck Traction Unit - UCTU359
Brace Direct Cervical Traction Device - CTU414
Brace Direct Home Cervical Traction Device - CTU359
Brace Direct Carbon Fiber AFO - FTB-CL-CK289
Brace Direct Leaf Spring AFO - FTB212
Brace Align Swedish Leaf Spring AFO - FTB302
Brace Direct StrideElite Leaf Spring AFO FTB419
Replacement Boot Liner Standard Short Walking Boot - ACS465
Brace Direct LevelUp - Walking Boot & Post-Op Shoe Leveler - FTB363
Brace Direct Replacement Sock Liner - ACS137
Brace Direct Recovery Ankle Extender - AKB218
Replacement Boot Liner Standard Tall Walking Boot - ACS466
Brace Direct Replacement Foam Wedge for 90 Degree Night Splint - ACS352
Brace Direct GreenRelief Silicone Cups - SHC421
SoftPro HKO Hip Abduction Orthosis L1652 - OCSI by Brace Direct - HPB344
Brace Direct Back Brace Extension Belt - BKB122
Brace Direct SI Joint Belt - BKB-CL-SI-100
Brace Align Back Brace Extension Belt - BKB123
Brace Direct Rehabilitating Infrared Knee Recovery Massage Therapy Unit - KMT240
Brace Direct Red Light Therapy Knee Massage Unit - KMT246
Brace Direct Rehabilitating Infrared Knee Joint Massage Therapy Unit - KMT192
Brace Direct Cold Therapy Pads for BlueIce Cryotherapy Unit - ACS383
Brace Direct Cold Therapy Pads for FrozenHeat and FrozenIce Cold Therapy Machines - ACS460
Renewed Brace Direct Thermal Rehabilitation Device - UCTY326
Brace Direct IcedHeat Hot and Cold Water Circulating Machine - CTY408
Brace Direct Digital Frozen Heat Therapy Unit - CTY159
Brace Direct Frozen Ice Cold Therapy Machine - CTY194
Brace Direct Cryo-Compression Recovery System - CTY206
Renewed Brace Direct Knee Ice Machine - UCTY194
Brace Align Hot and Cold Therapy Unit - CTY226
Brace Direct Blue Ice Cold Therapy Machine - CTY243
Brace Direct Frozen Heat Therapy Unit - CTY326
Brace Direct Cold Compression Wrap Pro for Lower Leg - CTY232
Brace Direct Digital Frozen Heat Hot and Cold Water Therapy Machine - CTY407
Brace Direct IcedHeat Hot and Cold Therapy Machine - CTY244
Renewed Brace Direct Thermal Rehab Machine - UCTY159
SoftPro Air Bladder Starter Kit for HKO Hip Abduction Orthosis - OCSI by Brace Direct - HPB344-ACS346
Brace Align KOAlign Osteoarthritis Soft Knee Brace - KNB374
Brace Direct Tri-Panel Knee Immobilizer - KNB235
Brace Direct Internal Deluxe Knee Brace with Hinge - KNB224
Multiligament Rehabilitator Knee Brace - Guardian by Brace Direct - KNB406
Brace Align Post Op Knee Brace - KNB233
Brace Align Comfort Plus Dual Adjustment OA Knee Brace for Osteoarthritis - KNB431
Brace Direct Hinged ROM Knee Brace - KNB-CL-CK-207
Stabilizing Compression Brace - Bort by Brace Direct - KNB114420
Brace Direct Hinged Knee Brace with Patella Stabilizer - KNB311
Brace Direct Deluxe Plus Size Internal Hinged Knee Brace - KNB163
SoftPro Bend to Fit Knee Orthosis - OCSI by Brace Direct - KNB387
Breg T Scope Premier Post-Op Knee Brace by Brace Direct - KNB367
Brace Align KOAlign Osteoarthritis Plus Size Knee Brace - KNB242
Brace Direct Dual Hinged ACL Knee Brace - KNB-CL-ER-208
Brace Align Osteoarthritis Offloading Knee Brace - KNB318
Brace Direct Dual Adjustment Osteoarthritis Knee Brace - KNB433
Brace Direct Neoprene Hinged Knee Brace - KNB200
Brace Direct ROM Knee Brace - KNB277
Brace Direct Patella Knee Strap - F4-64JB-A2FV
Brace Align ROM Unloader Knee Brace - KNB128
Brace Direct Patella Knee Strap - KSP197
OrthoPro Wraparound Stabilizer Knee Brace - KNB338
Brace Direct Osteoarthritis Unloader Knee Brace - KNB234
Brace Align KOAlign Osteoarthritis Knee Brace - KNB238
Brace Align FlexTrack ROM Telescoping Brace - KNB425
Multiligament Rehabilitator Knee Brace - Guardian by Brace Direct - KNB391
Brace Align KOAlign II OA Knee Brace - KNB247
Brace Align EasyStrap Pro OA Knee Brace - KNB427
Brace Direct External ROM Plus Size Knee Brace - KNB165
Brace Direct Hinged Knee Brace - KNB102
Brace Align Apex ACL Stabilizer - KNB428
SoftPro Static Knee Orthosis - OCSI by Brace Direct - KNB341
Brace Align ROM Knee Brace - KNB129
Brace Direct Post Op ROM Hinged T-Scope Knee Brace - KNB231
Brace Direct OA Unloader Knee Brace - KNB-OA-200
Brace Direct Hernia Support Belt - ABL-AD49
Brace Align Knee Brace Undersleeve - KNB306
Brace Direct Knee Brace Undersleeve - KNB198
Brace Direct Rain Cover - ACS171
Brace Direct Sport Compression Sleeve - KNB-CL67-100
Brace Direct Heated Knee Massage - KTU322
Brace Direct OA Unloader Plus Heated Knee Massager - KNB308
Brace Direct Heated Knee Massage - KTU256
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device