Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015459201

FEI Number

3015459201

Entity Name

BRACEABILITY, INC.

City/State/Country

Cedar Falls, IA, US

Establishment Address

6122 Nordic Drive, Cedar Falls, IA 50613, US

Establishment Type(s)

Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

BraceAbility, Inc. (Owner Number: 10060581)

Owner / Operator Contact Address

6122 Nordic Drive, Cedar Falls, IA 50613, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2020-02-07
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2021-07-10
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2025-08-15
LYG	Massager, Therapeutic, Manual	Physical Medicine	Class 1	890.5660	2022-05-09
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2022-05-09
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2019-05-29
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2021-07-10
KNP	Orthosis, Corrective Shoe	Physical Medicine	Class 1	890.3475	2021-07-07
OHI	Orthosis, Foot Drop	Physical Medicine	Class 1	890.3475	2020-02-07
IPG	Shoe, Cast	Physical Medicine	Class 1	890.3025	2023-04-03
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	Class 1	890.3490	2019-05-29
FQK	Binder, Perineal	General Hospital	Class 1	880.5160	2019-05-29
IPT	Orthosis, Thoracic	Physical Medicine	Class 1	890.3490	2021-07-10

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BraceAbility, 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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3010260768	VTS ONE MEMBER CO., Ltd.	Hai Phong City, VN
3011556461	COMFORT PLUS CORPORATION	New Taipei City, TW

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015459201. Last updated year: 2026. Please use registration number 3015459201 when referencing this establishment in official correspondence.