Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002798200

FEI Number

3002798200

Entity Name

FRONTIER THERAPEUTICS LIMITED

City/State/Country

Tredegar Blaenau Gwent, GB

Establishment Address

Innova One, Tredegar Business Park, Tredegar Blaenau Gwent NP22 3EL, GB

Establishment Type(s)

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

Owner / Operator

Frontier Theraputics Limited (Owner Number: 10055924)

Owner / Operator Contact Address

Innova One, Tredegar Business Park, Tredegar, GB-BGW NP22 3EL, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Repose Double Mattress Overlay Repose Mattress Overlay Enora Air Sleeper Repose Contur Repose Babynest Enora Air Contur Repose Babytherm Repose Pediatric Mattress Overlay Repose - Foot Protector Plus Repose - Wedge Dermisplus Prevent Repose Foot Protector Repose Flex Repose Sole Protector Repose Care-sit Repose Cushion Enora Air Seat Enora Air Cushion Toto Automated Lateral Turning System Enora Air Sleeper Cover Repose Cushion Cover Repose Mattress Cover Enora Air Cushion Cover

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IKY	Mattress, Flotation Therapy, Non-Powered	General Hospital	Class 1	880.5150	2024-12-06
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2017-10-18
KIC	Cushion, Flotation	Physical Medicine	Class 1	890.3175	2024-12-06
IKZ	Bed, Patient Rotation, Powered	Physical Medicine	Class 2	890.5225	2019-02-18
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2024-12-06

Official Correspondent

No official correspondent registered.

US Agent Details

Joseph Bockus Business: Frontier Therapeutics Inc Email: jbockus@frontier-therapeutics.com Phone: (716) 7130549

Related Public Records

Same Entity

Frontier Theraputics Limited

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3008775647	SHAKAM, LLC	Columbus, OH, US
3018115503	COMFORT CARE PRODUCTS, LLC	Newberry, SC, US
3032847786	Cutters Foam Fabricating, Inc.	Elkhart, IN, US
3004116007	Legs 4 Life, LLC	ASHEBORO, NC, US
3009056001	STME Acquisition LLC	Palmetto, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002798200. Last updated year: 2026. Please use registration number 3002798200 when referencing this establishment in official correspondence.