Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004198457

FEI Number

3004198457

Entity Name

JAC CUSTOM POUCHES

City/State/Country

Dowagiac, MI, US

Establishment Address

605 Percy St, Dowagiac, MI 49047, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

JAC Custom Pouches (Owner Number: 10054675)

Owner / Operator Contact Address

605 Percy Street, Dowagiac, MI 49047, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Restraint Strap (Accessory) Restraint Strap Restraint Strap (Accessory)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FPO	Stretcher, Wheeled	General Hospital	Class 2	880.6910	2020-12-14
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2017-04-17
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2018-05-22
INK	Stretcher, Wheeled, Powered	Physical Medicine	Class 2	890.3690	2021-01-21

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

JAC Custom Pouches

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K962327	Sekure Seat Corp.	SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE	1997-03-06
K963243	Heelbo, Inc.	HEELBO BLAZER SLEEVED JACKET	1996-10-01

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0023-05	Stryker Medical	2	Stryker brand Rugged EZ-Pro R4 Ambulance Cot, model 6092.

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1033902	FUTURE HEALTH CONCEPTS, INC.	Sanford, FL, US
3007744192	HEBEI PUKANG MEDICAL INSTRUMENTS CO.,LTD	Baoding Hebei, CN
3003674698	MedSource Labs, LLC	Chanhassen, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004198457. Last updated year: 2026. Please use registration number 3004198457 when referencing this establishment in official correspondence.