FDA Registration
Active
🇺🇸 United States
Bauerfeind USA, INC.
Reg #: 1037964
·
FEI: 1037964
·
Expires 2026
Products
5
Proprietary Names
19
Establishment Types
1
Classifications
5
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Registration Details
- Registration Name
- Bauerfeind USA, INC.
- Registration Number
- 1037964
- FEI Number
- 1037964
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 75 14th St NE, Suite 2350
- City
- Atlanta
- State
- GA
- ZIP
- 30309
- Country
- US
Owner / Operator
- Firm Name
- Bauerfeind USA
- Operator Number
- 10029793
- Address
- 75 14th Street NE, Suite 2350
- City
- Atlanta
- State
- GA
- Postal Code
- 30309
- Country
- US
- Correspondent
- Michael Cannon
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2025-09-24 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2025-12-11 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2025-12-11 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2025-12-11 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2025-09-24 |
Proprietary Names
b:joynz air walker
b:joynz night splint
b:joynz air walker achilles
b:joynz ankle brace
b:joynz ankle stirrup
b:joynz walker
b:joynz air walker soft
b:joynz knee brace pro
b:joynz knee immobilizer 20
b:joynz knee ROM
b:joynz knee brace
b:joynz knee immobilizer 0
b:joynz wrist and thumb brace
b:joynz wrist brace
b:joynz LSO plus
b:joynz LSO basic
b:joynz LSO unload
b:joynz shoulder immobilizer 15
b:joynz shoulder immobilizer
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility