FDA Registration
Active
🇺🇸 United States
PrecisionMotion ROM Wrist Brace WRB436
Reg #: 3013002868
·
FEI: 3013002868
·
Expires 2025
Products
1
Proprietary Names
82
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BRACE ALIGN
- Registration Number
- 3013002868
- FEI Number
- 3013002868
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 6860 Big Ridge Road
- City
- Hixson
- State
- TN
- ZIP
- 37343
- 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 |
|---|---|---|---|---|---|
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2016-08-19 |
Proprietary Names
PrecisionMotion ROM Wrist Brace WRB436
Brace Align FlexRecover Elbow Brace EBB429
KNW214
WRB217
ThumbAlign
Brace Align/Direct ROM Knee Brace KNB102/KNB129
BTS-AD320
FTB361
Brace Align/Direct Dorsal Night Splint NTS109/NTS264
KSP197
WRB228
BTS249
WRB303
BTS357
FTB302
BTS104
POST276
BTS219
EBB239
BTS297
WRW258
Brace Align/Direct KOAlign KNB128/KNB234/KNB247/KNB277
BTS119
EBB136
WRB209
Brace Align/Direct 90 Degree Night Splint FTB132/FTB257
FTB259
KNB-CL-CK-207
BTS108
WRB115
Brace Align/Direct Full Shell Walker -- Short BTS207/BTS278
KNB-CL-ER-208
KSP204
WRB274
ARB-AD5100-E
BTS296
WRW111
ARB199
BTS295
WRB310
BTS221
FTB158
Brace Direct Obese ROM Knee Brace KNB163/KNB165/KNB224
Brace Align KOAlign Wrap KNB238/KNB242
FTB241
KNB318
BTS-AD31
FTB328
BTS315
FTB-CL-CK-289
BTS220
FTB133
BTS222
PFD210
WRB299
BTS107
WRB113
KNB235
POS294
KNB200
BTS103
KNB311
POS313
EBB135
FTB-CL63-105
Brace Direct Plantar Fasciitis Day Splint FTW201
KNB231
POS110
FTB255
KNB-CL67-100
KNB233
POS223
FTB162
BTS105
WRB106
KNB-OA-200
BTS118
WRB166
FTB212
FTB254
KNB374
Brace Align Stabilizing ROM Hinged Elbow Brace EBB135
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility