Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007005431

FEI Number

3007005431

Entity Name

SHL Healthcare Ltd.

City/State/Country

SHENZHEN Guangdong, CN

Establishment Address

BLD.8, A-6 TONGFUYU INDUSTRIAL PARK, BU-CHONG, SHAJING TOWN, BAOAN DISTRICT, SHENZHEN Guangdong 518104, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SHL Healthcare Ltd. (Owner Number: 9104842)

Owner / Operator Contact Address

Bld.8 A-6 Tongfuyu Industrial Park, Bu-Chong, Shajing Town, Baoan District, Shenzhen, CN-GD 518104, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AIR+ pump Citadel C200 Integrated Mattress Citadel C100 Integrated Mattress IsoTour Pump (accessory) IsoAir IsoTour

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IOQ	Bed, Flotation Therapy, Powered	Physical Medicine	Class 2	890.5170	2019-11-20
FNM	Mattress, Air Flotation, Alternating Pressure	General Hospital	Class 2	880.5550	2007-07-24
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	Class 1	880.5510	2010-11-10
IKY	Mattress, Flotation Therapy, Non-Powered	General Hospital	Class 1	880.5150	2025-01-13

Official Correspondent

Mourice Mo

US Agent Details

James Haynes Email: James.Haynes@shl-medical.com Phone: (954) 7252046

Related Public Records

Same Entity

SHL Healthcare Ltd.

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
K890935	Dermanetics Corp.	SYSTEM 3000 FLUIDIZED AIR BED	1989-03-15

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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007005431. Last updated year: 2026. Please use registration number 3007005431 when referencing this establishment in official correspondence.