Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042026071

FEI Number

3042026071

Entity Name

AXOLOHEALTH

City/State/Country

Charlotte, NC, US

Establishment Address

C/O Ortho Carolina Hand Center, Attn Dr. Glenn Gaston, 1915 Randolph Rd, Charlotte, NC 28207, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

AxoloHealth (Owner Number: 10094253)

Owner / Operator Contact Address

C/O Ortho Carolina Hand Center, Attn Dr. Glenn Gaston, 1915 Randolph Rd, Charlotte, NC 28207, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TBR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QKC	Interactive Rehabilitation Exercise Device, Prescription Use	Physical Medicine	Class 2	890.5360	2025-11-20

Official Correspondent

Chip Standifer

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AxoloHealth

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 3042026071. Last updated year: 2026. Please use registration number 3042026071 when referencing this establishment in official correspondence.