Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616471

FEI Number

3003080630

Entity Name

Direct Healthcare Group Limited (THE KIRTON HEALTHCARE GROUP LTD)

City/State/Country

Caerphilly, GB

Establishment Address

Withey Court, Western Industrial Estate,, Caerphilly CF83 1BF, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Direct Healthcare Group (Owner Number: 10047964)

Owner / Operator Contact Address

6 - 10 Withey Court, Western Industrial Estate, Caerphilly, GB-NOTA CF83 1BF, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Dyna Flex Cushion Transflo Cushion Dyna Tek Intelligent Air Cushion Dyna Tek Superior Dyna Tek Pad Raizer II + Headrest Raizer II Raizer M Raizer M + Headrest & Cover Dyna Form Mercury Advance Bari Mattress System Dyna Form Mercury Advance Cushion Dyna Form Mercury Advance Mattress System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KIC	Cushion, Flotation	Physical Medicine	Class 1	890.3175	2022-12-22
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	Class 1	880.5510	2022-12-22
FNM	Mattress, Air Flotation, Alternating Pressure	General Hospital	Class 2	880.5550	2022-12-22

Official Correspondent

Miriam Walls

US Agent Details

Miriam Walls Business: XFDA INC Email: mwalls@xfda.com Phone: (703) 9195372

Related Public Records

Same Entity

Direct Healthcare Group

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-0013-2018	Handicare Usa Inc	1	PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered
Z-0014-2018	Handicare AB Maskinvagen	1	Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009

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3026818268	TUPER MEDICAL CO., LTD.	Dezhou City Shandong, CN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616471. Last updated year: 2026. Please use registration number 9616471 when referencing this establishment in official correspondence.