FDA Registration
Active
🇺🇸 United States
BECKER ORTHOPEDIC APPLIANCE CO.
Reg #: 1824252
·
FEI: 1000042994
·
Expires 2026
Products
20
Proprietary Names
355
Establishment Types
3
Classifications
20
Registration Details
- Registration Name
- BECKER ORTHOPEDIC APPLIANCE CO.
- Registration Number
- 1824252
- FEI Number
- 1000042994
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 635 Executive Dr
- City
- TROY
- State
- MI
- ZIP
- 48083
- Country
- US
Owner / Operator
- Firm Name
- BECKER ORTHOPEDIC APPLIANCE CO.
- Operator Number
- 1824252
- Address
- 635 EXECUTIVE DR., --
- City
- Troy
- State
- MI
- Postal Code
- 48083
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Cervical-Thoracic, Rigid | IQF | Class 1 | Physical Medicine | No | 2007-06-12 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2001-12-10 |
| Twister, Brace Setting | ITO | Class 1 | Physical Medicine | No | 2007-06-12 |
| Joint, Elbow, External Limb Component, Mechanical | IRD | Class 1 | Physical Medicine | No | 2007-06-12 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2001-12-10 |
| Orthosis, Thoracic | IPT | Class 1 | Physical Medicine | No | 2001-12-10 |
| Component, External, Limb, Ankle/Foot | ISH | Class 1 | Physical Medicine | No | 2017-04-14 |
| Joint, Hip, External Brace | ITS | Class 1 | Physical Medicine | No | 2007-06-12 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2007-06-12 |
| Orthosis, Lumbo-Sacral | IPY | Class 1 | Physical Medicine | No | 2001-12-10 |
| Device, Prosthesis Alignment | IQO | Class 1 | Physical Medicine | No | 2017-02-09 |
| Splint, Denis Brown | ITN | Class 1 | Physical Medicine | No | 2013-01-15 |
| Hand, External Limb Component, Mechanical | IRA | Class 1 | Physical Medicine | No | 2021-08-12 |
| Orthosis, Truncal/Orthosis, Limb | MRI | Class 1 | Physical Medicine | No | 2007-06-12 |
| Cover, Limb | IPM | Class 1 | Physical Medicine | No | 2017-02-09 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2007-06-12 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2007-06-12 |
| Stirrup, External Brace Component | ITC | Class 1 | Physical Medicine | No | 2007-06-12 |
| Orthosis, Foot Drop | OHI | Class 1 | Physical Medicine | No | 2019-10-03 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2001-12-10 |
Proprietary Names
C-14A-TE Pacific Adjustable Collar with Thoracic Extension
C-14AG-TE-S-M PACIFIC ADJUSTABLE COLLAR W/ TE & GLIDEWEAR LINER - SM - MD
C-14AG-TE-M-L PACIFIC ADJUSTABLE COLLAR W/ TE & GLIDEWEAR LINER - MD - LG
327 Plastic KAFO with Articulating Ankle
230 Genu Valgum KAFO
332 Monodos KAFO
235 Genu Varum KAFO
620 Jousto AFO
CSO Gillette Crutchless Standing Orthosis
615 Drop Foot Splint - Full Foot
319 Load Response KAFO
617 Drop Foot Splint - Dynafo
325 Plastic KAFO with Solid Ankle
225 Metal and Leather KAFO
9008 PreStride4
323 Custom Stride4 KAFO
322 Custom FullStride KAFO
9007 PreStride
321 Custom SafetyStride KAFO
R-400 Bilateral Hip-Knee-Ankle Torsion Splint
L-400 Bilateral Hip-Ankle Torsion Splint
H-400 Bilateral Hip-Knee Torsion Shafts Attached to AFO's
K-400 Bilateral Hip-KAFO Torsion Splint
TORSION SPLINT
337 Ratchet Lock Elbow Orthosis
MODEL S-1009 Polycentric Elbow Joint
331 Monodos Custom Elbow Orthosis
336 Variloc Elbow Orthosis
1700 Adjustable Positioning Joint
355 Plastic Knee Orthosis
1075 Adjustable Extension Ring Lock Aluminum Thrust Bearing Knee Joint
9005 SafetyStride
MX-002-101/MX-005-101 Lever Assist Strap
BCO-Max-KAFO BCO Max KAFO
434 SKO Drop Lock Knee Orthosis
BCO-LITE-KAFO BCO Lite KAFO
9000 GX-Knee
2009 Automatic Ring Lock Knee Joint
1402 Modular Ring Lock Knee Joint
S2005 Free Motion Knee Joint Assembled With Bushing And Screw
9004 UTX KAFO
1006 Series Adjustable Extension Ring Lock Knee Joint
1065 Ring Lock Aluminum Thrust Bearing Knee Joint
S2003 Automatic Ring Lock Knee Joint
1090 Ring Lock Aluminum Thrust Bearing Hip Joint
MX-001-000 Anterior Pull-Cable Kit
1010 Series Adjustable Extension/Flexion Ring Lock Knee Joint
437 SKO Extension Assist Knee Orthosis
1096 Adjustable Extension Ring Lock Aluminum Thrust Bearing Hip Joint
S2001 Ring Lock Knee Joint Assembled With Bushing And Screw
1003 Series Automatic Spring Lever Knee Joint
1015 Series Key Lock Knee Joint
1005 Series Free Motion Knee Joint
1001 Series - Ring Lock Knee Joint
LR-9002 Load Response Knee Joint
1007 Adjustable Extension Automatic Spring Lever Knee Joint
1013 Posterior Offset Adjustable Knee Joint
1900 Monodos Joint
BCO-Shadow-KAFO BCO Shadow KAFO L
R2005 Free Motion Knee Joint Unassembled With Rivet
9006 FullStride
1009 Series Polycentric Free Motion Knee Joint
1017 Automatic Angled Lever Lock
1095 Two Position Ring Lock Aluminum Thrust Bearing Hip Joint
1002 Series - Modified Ring Lock Knee Joint
1018 Modular Ratchet Lock Knee Joint
1014 Series Ratchet Lock Knee Joint
1012 Series Posterior Offset Ring Lock Knee Joint
1011 Series Automatic Trigger Lock Knee Joint
1600 Single Axis Free Motion Overlap Knee Joint
1055 Free Motion Aluminum Thrust Bearing Knee Joint
S1700 Adjustable Positioning Joint with Straight Lower Bar
1008 Series Posterior Offset Free Motion Knee Joint
1004 Series Posterior Offset Lever Lock Knee Joint
1085 Free Motion Aluminum Thrust Bearing Hip Joint
9015 GXL-Knee
1016 Series Tricknee
MX-003-HD Heavy Duty Lever Release System
MX-003-BLISS BLISS Lever Release System
444 Lerman 3-Point Knee Orthosis
9002 Load Response Knee Joint without Spring
L-25A Hyperextension TLSO With Swivel Sternal Pad & Dot Fastener Closure
W-26A Hyperextension TLSO With Stationary Sternal Pad & Worm Gear Closure
W-29A Hyperextension TLSO With Deltopectoral Pads & Worm Gear Closure
Q-29A Hyperextension TLSO With Deltopectoral Pads & Quick Release Closure
Q-25A Hyperextension TLSO With Swivel Sternal Pad & Worm Gear Closure
Q-26A Hyperextension TLSO With Stationary Sternal Pad & Quick Release Closure
W-30A Hyperextension TLSO With Deltopectoral Pads, Pelvic Bar & Worm Gear Closure
Q-27A Hyperextension TLSO With Swivel Sternal Pad, Pelvic Bar & Quick Release Closure
L-26A Hyperextension TLSO With Stationary Sternal Pad & Dot Fastener Closure
L-30A Hyperextension TLSO With Deltopectoral Pads, Pelvic Bar & Dot Fastener Closure
Q-25A Hyperextension TLSO With Swivel Sternal Pad & Quick Release Closure
Q-27A Hyperextension TLSO With Swivel Sternal Pad, Pelvic Bar & Worm Gear Closure
Q-30A Hyperextension TLSO With Deltopectoral Pads, Pelvic Bar & Quick Release Closure
L-29A Hyperextension TLSO With Deltopectoral Pads & Dot Fastener Closure
Q-35A Dynamic Extension Orthosis
L-27A Hyperextension TLSO With Swivel Sternal Pad, Pelvic Bar & Dot Fastener Closure
Ultra-G
1020 Ring Lock Hip Joint
145 Lerman Hip Abduction Rotation Orthosis 2000
2025 Aluminum Free Motion Hip Joint
2045 B3 Triple Axis Hip Joint
1026 Adjustable Flexion Ring Lock Hip Joint
1040 and 1041 Millenium Hip Joint
2050 Spherical Hip Joint
2020 Aluminum Ring Lock Hip Joint
2040 Econohip Joint
1022 Modified Ring Lock Hip Joint
1023 Trigger Lock Hip Joint
1025 Free Motion Hip Joint
227 Bilateral HKAFO
2041 Econohip Joint with Adjustable Abduction/Adduction
HFAD-Hip Flexion Assist Device
2032 Two Position Ring Lock Hip Joint
228 Unilateral HKAFO
980 Quick Disconnect
1030 Abduction Flexion Hip Joint
160 Spherical Hip Abduction Orhtosis
147 Maple Leaf Orthosis
106 Knight LSO
101 Knight-Taylor TLSO
108 Williams LSO
100 Taylor TLSO
107 Norton Brown LSO
105 Chairback LSO
116 Baldwin Belt
117 Bellaire Comfort LSO Brace
119 Alpena Contour LSO Brace
118 Oscoda Comfort LSO Brace
Techno TechnoSpine
SpineCor
SpineCor Brace
LSO Back Brace
P4030 Coupler
P4020 Hyperbolic Ankle Block
500 Foot Plate Denis Browne Splint with Solid Bar
Wilmer Elbow Orthosis
190 Lerman Pediatric Shoulder Abduction Rotation Orthosis
GW GlideWear
749 Shearban
775 Flexible Ankle Joint
3025 Standard Action Ankle Joint
SLM-2825 Stride Ankle Joint
780 & 781 Scotty Free Motion Ankle Joints
740-3 Hex Tools
2825 Original Double Action Ankle Joints
T-740-3 Spanner Wrench Tool
SL2835 Slim Line Double Action With Attached Upright
655 Motion Control Limiter
3725 Phelps Round Upright Only
741-CAP Tamarack Flexure Joint Caps
375 MCAD Articulating Ankle AFO By Measurement
3266 -X Split Stirrup Uprights with Ankle Joints and Wide Flange Caliper Plate
SC-2845 - Double Action Ankle Joint Standard One-piece Aluminum
790 Kid-Dee-Lite
741 Tamarack Molding Dummies
2835 Double Action Ankle Joint with Attached Upright
T-740-4 Tamarack Hex Driver
SL2845-A Slim Line One-Piece Aluminum Double Action Ankle Joint and Upright
3225 Dorsiflexion Assist Ankle Joint Units
2850-SX Wide Flange Long Tongue Webbed Stirrup with Double Action Ankle Joints
X3245-A Adult One-Piece Aluminum Dorsiflexion Plus Ankle Joint and Upright
3C Triple Action Ankle Joint Pediatric
370 Plastic AFO With Non Articulating Ankle
755 Motion Control Limiter
2962 Split Stirrup Upright with Ankle Joint
SLI/SLO-2850-A Wide Flange Stirrup with Slim Line Double Action Ankle Joints
3245 One-Piece Aluminum Dorsiflexion Assist Ankle Joint and Upright
X3266 Split Stirrups with One-Piece Ankle Joint Uprights and Caliper Plate
950 Foot Control Plate
3066-X Split Stirrup Uprights with Ankle Joints and Wide Flange Caliper Plate
2850 Wide Flange Stirrup with Double Action Ankle Joints
TISLI/TISLO-2825 Titanium Slim Line Double Action Ankle Joints
SLI-2966 & SLO-2966 Slim Line Split Stirrups with Ankle Joints and Caliper Plate
370 ECAD Solid Ankle AFO By Electronic File
725 Compact Double Action Ankle Joint
741-ML Tamarack Plantar Flexion Limiter Kit
750 Camber Axis Hinge
395 Progressive AFO
SLI/SLO-2825 Slim Line Double Action Ankle Joint with Attached Upright
BCO-Max-AFO BCO Max AFO
360 PTB Orthosis
3062 Split Stirrup Upright with Ankle Joint
3250 Standard Flange Stirrup with Dorsiflexion Assist Ankle Joints
X3266-X Split Stirrups with One-Piece Ankle Joint Uprights and Wide Flange Caliper Plate
795 Motion Limiter
742 Tamarack Dorsiflexion Assist Flexure Joint
3066 Split Stirrup Uprights with Ankle Joints and Caliper Plate
2845 One-Piece Aluminum Double Action Ankle Joint and Upright
TI-2825 Titanium Slim Line Ankle Joint
SLI-2962 & SLO-2962 Slim Line Split Stirrup with Ankle Joint
761 Oklahoma Ankle Joint Parts
2966-X Split Stirrup Uprights with Ankle Joints and Wide Flange Caliper Plate
SLI/SLO-2850-X Wide Flange Long Tongue Stirrup with Slim Line Double Action Ankle Joints
775-HD Heavy-Duty Flexible Ankle Joint
340 Floor Reaction AFO
3035 Standard Action Ankle Joint with Attached Upright
T-740-1 Hand Molding Tool
3B Triple Action Ankle Joint Small Adult
765 Heavy-Duty Nylon Oklahoma Ankle Joint Kit
3010-Y Standard Action Ankle Joints
SLI/SLO-2950 Standard Flange Stirrup with Slim Line Double Action Ankle Joints
BCO-Shadow-AFO BCO Shadow AFO
3235 Dorsiflexion Assist Ankle Joint with Attached Upright
2850-X Wide Flange Long Tongue Stirrup with Double Action Ankle Joints
X3262 Split Stirrup with One-Piece Ankle Joint Upright
345 Tone Reducing AFO (TRAFO)
3045 One Piece Aluminum Standard Action Ankle Joint w/Upright (1 PC ALUM STD ACTION ANKLE JNT W/UPR)
T-740-2 Hand Punch
760 Polypropylene Oklahoma Ankle Joint Kit
2966 Split Stirrup Uprights with Ankle Joints and Caliper Plate
SLI/SLO-2850-SX Slim Line Wide Flange Long Tongue Webbed Stirrup with Double Action Ankle Joints
375 ECAD Articulating AFO By Electronic File
3262 Split Stirrup Upright with Ankle Joint
2825HD/2825-A38 - Double Action Ankle Joint Heavy Duty
747 Tamarack Clevisphere Ankle Joint
3880 Patten-Bottom
SLI-2966-X & SLO-2966-X Slim Line Split Stirrups with Ankle Joints and Wide Flange Caliper Plate
350 CRO Walker
3050 Standard Flange Stirrup with Standard Action Ankle Joints
726 Modular Compact Double Action Ankle Joint
270 Metal and Leather AFO
396 XAFO Kit
370 MCAD Solid Ankle AFO By Measurement
379 Plastic & Metal AFO
3A Triple Action Ankle Joint Adult
372 SMO
3B00-GEO
3850 Single Upright Free Motion Stirrup with Standard Action Ankle Joint Unit
776 Dorsi Assist Flexible Ankle Joints
740 Tamarack Flexure Joint
272 Phelps Caliper AFO
M3025 Modular Standard Action Ankle Joint
743 Tamarack Variable Assist
3870 Bushing Adapter Ring
378 Clamshell AFO
333 Monodos AFO
751 Camber Axis Technic
396 XAFO
2950 Standard Flange Stirrup with Double Action Ankle Joints
SLI/SLO-2825 Slim Line Double Action Ankle Joints
375 Plastic AFO With Articulating Ankle
3266 Split Stirrup Uprights with Ankle Joints and Caliper Plate
394 Richie Brace
LET Flexion Control Ankle Joint
FC2 Flexion Control Ankle Joint
MI MiLine Metric Interchangeable
Method TA - Men's Size 46EUR (11US) Large, Right
Method TA - Men's Size 46EUR (11US) Large, Left
Method TA - Women's Size 40EUR (9US) Small, Right
Method TA - Women's Size 40EUR (9US) Small, Left
U-10 Functional Positioning Splint
1500 Becker Free Motion Elbow Joint
731-3 Dynamic Thumb Extension Module
UM-3.3 Dynamic WHO With Wrist and Finger Extension
334 Monodos Wrist Orthosis
U-8 Wrist Hand Thumb Splint
U-7 Wrist Hand Splint
U-17C Custom Wrist Driven Hand Orthosis
U-18C Custom Ratchet Wrist Hand Orthosis
731-2 Static Thumb Control
UM-2.2 Dynamic Wrist Hand Orthosis With Finger Extension
WCO2 WILMER 2 CARRYING ORTHOSIS
U-16 Prefabricated Static Wrist Hand Orthosis
U-16C Custom Static Wrist Hand Orthosis
WCO2-HS WILMER 2 CARRYING ORTHOSIS W/ HAND SUPPORT
U-17 Prefabricated Wrist Driven Wrist Hand Orthosis
731-1 Palmar Unit
UM-1 Ulnar Drift Wrist Hand Orthosis
U-30-2 Range of Motion Elbow Joint
U-45 Range of Motion Wrist Joint
U-6 Carpal Tunnel Splint
U-18 Prefabricated Ratchet Wrist Hand Orthosis
731-6 MP Blocker
WCO Wilmer Carrying Orthosis
731-4LP or 731-4RP Dynamic Thumb Flexion Module With Palmar Unit
UM-4 Dynamic WHO with Finger Flexion
W3000 Standard Action Wide Flange Stirrup Only
3064 Split Stirrup Uprights with Caliper Plate
K3210 - Dorsiflexion Plus Stirrup Insert Only
3400-X Wide Flange Split Stirrup Caliper Plate Only
3000 Wide Flange Stirrup Only
SL2964-X Slim Line Split Stirrup Uprights with Wide Flange Caliper Plate
KW3200 - Dorsiflexion Assist K-Series Wide Flange Stirrup Only
SC-30 Stirrup Strut
3264-X Split Stirrup Uprights with Wide Flange Caliper Plate
3064-X Split Stirrup Uprights with Wide Flange Caliper Plate
K3200-X - Dorsiflexion Assist Wide Flange 6in Stirrup Only New Style
SL2960 Slim Line Split Stirrup Upright Only
3650 Caliper Plate with Upright Attachments
2800-BL - Wide Flange Stirrup Blank
3210 Dorsi Assist Stirrup
X3210-A Stirrup Insert Only
2800 Wide Flange Stirrup Only
3700 Phelps Caliper Plates and Uprights
3210-Y Y Stirrup Insert Only
3870 - Bushing Adapter Ring
X3260 Split Stirrup Upright Only
2900 Standard Flange Stirrup Only
3200 Wide Flange Stirrup Only
3200-X Dorsiflexion Assist Wide Flange 6in Stirrup Only
SSL2810Y Slim Line Stirrup Y Insert Only
KSX3200 - Dorsiflexion Assist K-Series Webbed Flange Stirrup Only
SL2900-B Slim Line Youth Stirrup Only
3600 Caliper Plate Only
3700-S Phelps Caliper Plate with Double Backstop
3260 Split Stirrup Upright Only
3550 Caliper Plate with Upright Attachments
2800-X - Stirrup Standard Wide Flange 6in Tongue
SL2900-A Slim Line Adult Stirrup Only
3600 90 Degree Posterior Stop Caliper Plates and Upright Attachments
3500 Free Motion Caliper Plates and Attachments
3010 Stirrup Insert Only
X3264-X Split Stirrup Uprights with Wide Flange Caliper Plate
2964 Split Stirrup Uprights with Caliper Plate
3200 Standard Flange Stirrup Only
K3200 Dorsiflexion Assist K-Series Standard Flange
3400 Split Stirrup Caliper Plate Only
2964-X Split Stirrup Uprights with Wide Flange Caliper Plate
3750 Phelps Caliper Plate with Round Upright
3264 Split Stirrup Uprights with Caliper Plate
3515 Caliper Pin Only
3060 Split Stirrup Upright Only
X3264 Split Stirrup Uprights with Caliper Plate
2960 Split Stirrup Upright Only
X3200-A Adult Stirrup Only
SL2810Y Slim Line Y Stirrup Insert Only
2700 Standard Flange Stirrup with 2800 Head
3525 Upright Attachment with Caliper Pin
3210 Stirrup Insert Only
SC-SL2800-A-Y - Slim Line Stirrup Y Insert Only Stance Control
W3200 Dorsiflexion Assist Wide Flange Stirrup Only
SL2800-SX Stirrup Only
SX3000 Standard Action Webbed Flange Stirrup Only
K3260 - Dorsiflexion Assis K-Series Split Stirrup Upright Only
X3200 Dorsiflexion Plus Standard Flange Stirrup Only
SL2810 Slim Line Stirrup Insert Only
SX3200 Dorsiflexion Assist Webbed Flange Stirrup Only
K3210-Y - Dorsiflexion Assist K-Series Y Stirrup Insert Only
SL2900-C Slim Line Child Size Stirrup Only
3625 Upright Attachment with Caliper Pin
SL2800-A Stirrup Only
X3210-A-Y Y-Stirrup Insert Only
2810 Double Action Stirrup Insert Only
SL2964 Slim Line Split Stirrup Uprights with Caliper Plate
2800-SX - Stirrup Web Config 7in Tongue
X3000 Standard Action Long Flange Stirrup Only
SL2800-X Stirrup Only
SC-SL2810/SC-SL2800 Stride Stirrups
3B00-FCF
C-24 Lerman Noninvasive Pediatric HALO System
C-14 Pacific Adjustable Collar
C-14AG-M-L PACIFIC ADJUSTABLE COLLAR W/ GLIDEWEAR LINER - MEDIUM-LARGE
C-14AG-S-M PACIFIC ADJUSTABLE COLLAR W/ GLIDEWEAR LINER - SMALL-MEDIUM
HUC Heads Up Orthosis
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198