Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3024755175

FEI Number

3024755175

Entity Name

COMFORBACK INC

City/State/Country

Auburndale, MA, US

Establishment Address

77 Rowe St. Unit 046, Auburndale, MA 02466, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Comforback Inc (Owner Number: 10086284)

Owner / Operator Contact Address

405 Waltham St # 119, Lexington, MA 02421, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Night Support Wrist Brace 3-Strap Wrist Brace Quick-Strap Wrist & Thumb Brace Airmax Hinged Knee Brace Post-Op Knee Brace GeniX ROM Adjustable Hinged Knee Brace Adjustable Cervical Collar Standard Adjustable Cervical Collar Quick-Lock Ankle Brace with Crossing Straps Fitgo Lace-Up Ankle Stabilizer Adjustable Ankle Stabilizer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2026-05-26
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2026-05-27
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2026-05-26
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2026-05-27

Official Correspondent

Lingjun Zhu

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Comforback Inc

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2025	Ossur H F Grjothals 5 Reykjavik Iceland	1	Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101

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3023344913	AR ORTHOPEDICS, LLC	Newberry, FL, US
3041725026	Fill Mill	Lakewood, NJ, US
3012316249	COMPASS HEALTH BRANDS (CORPORATE OFFICE)	Middleburg Heights, OH, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3024755175. Last updated year: 2026. Please use registration number 3024755175 when referencing this establishment in official correspondence.