Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015423385

FEI Number

3015423385

Entity Name

FRONTIER THERAPEUTICS INC.

City/State/Country

Buffalo, NY, US

Establishment Address

505 Ellicott St, Suite A5, Buffalo, NY 14203, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Frontier Therapeutics Inc. (Owner Number: 10059719)

Owner / Operator Contact Address

505 Ellicott St, Suite A5, Buffalo, NY 14203, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Repose Babynest Repose Babytherm ReposeTrolley Mattress Overlay Repose Pediatric Mattress Overlay Repose Double Mattress Overlay Repose Mattress Overlay Repose Contur Overlay Enora Air Sleeper Enora Air Contur Dermisplus Prevent Repose Foot Protector Plus Repose Foot Protector Repose Wedge Repose Sole Protector Repose Flex Repose Mattress Cover Enora Air Cushion Cover Repose Cushion Cover Enora Air Sleeper Cover Repose Care-Sit Repose Cushion Enora Air Seat Enora Air Cushion Repose Companion Repose Trolley Companion

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	2019-05-29
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2019-05-29
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2019-05-29
KIC	Cushion, Flotation	Physical Medicine	Class 1	890.3175	2021-11-11
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2019-05-29

Official Correspondent

Joseph Bockus

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Frontier Therapeutics Inc.

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 3015423385. Last updated year: 2026. Please use registration number 3015423385 when referencing this establishment in official correspondence.