Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003775414

FEI Number

3003775414

Entity Name

POWERbreathe International Ltd

City/State/Country

SOUTHAM Warwickshire, GB

Establishment Address

NORTHFIELD RD., SOUTHAM Warwickshire CV47 0FG, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

POWERbreathe International Ltd (Owner Number: 9052411)

Owner / Operator Contact Address

NORTHFIELD RD., Southam, WARWICKSHIRE, GB-NOTA CV47 0FG, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

POWERbreathe I/RMT KH-Series POWERbreathe

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ISD	Exerciser, Measuring	Physical Medicine	Class 2	890.5360	2018-06-15
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2007-11-01

Official Correspondent

Sarah Hicks

US Agent Details

Debbie Schooley Business: CREATIVE HEALTH PRODUCTS INC Email: debbie@chponline.com Phone: (734) 9965900

Related Public Records

Same Entity

POWERbreathe International Ltd

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 3003775414. Last updated year: 2026. Please use registration number 3003775414 when referencing this establishment in official correspondence.