Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1037964

FEI Number

1037964

Entity Name

Bauerfeind USA, INC.

City/State/Country

Atlanta, GA, US

Establishment Address

75 14th St NE, Suite 2350, Atlanta, GA 30309, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Bauerfeind USA (Owner Number: 10029793)

Owner / Operator Contact Address

75 14th Street NE, Suite 2350, Atlanta, GA 30309, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2025-09-24
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2025-12-11

Official Correspondent

Michael Cannon

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Bauerfeind USA

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1037964. Last updated year: 2026. Please use registration number 1037964 when referencing this establishment in official correspondence.