Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006339858

FEI Number

3006339858

Entity Name

Apex Medical (Kunshan) Corp.

City/State/Country

Kunshan City Jiangsu, CN

Establishment Address

No.1368, Zi Zhu Rd., Kunshan Kai Fa Hi-Tech,, Kunshan City Jiangsu 215316, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Wellell Inc. (Owner Number: 9001426)

Owner / Operator Contact Address

No. 9, MIN SHENG ST., TU-CHENG,, NEW TAIPEI CITY, TW-TPE 236044, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sedens 500 ACS Series Pump and Mattress SERENE Series Pump and Mattress Serene Bariatric Optima Auto Optima Prone Optima Turn PRO-CARE Series Pump and Mattress DOMUS 3 Pump and Mattress DOMUS Auto Pump and Mattress Sedens 400 DOMUS 2S Pump and Mattress Procare Elite Procare Auto Link G3 Domus ECO Domus 1 G2 Procare Auto G2 DOMUS 1 Pump and Mattress Domus Auto G2 Domus Bariatric G2 DOMUS 4 Pump and Mattress Domus 3D Serene Elite Serene Air Domus 4 G2 Pump Procare Bariatric G2 Procare Auto G3 Domus 2 G2 Sedens 500 SE Crossover Nio VenAir, Sequential Compression System Procare Auto G3 Seat cushion Mini Star Minicare

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FNM	Mattress, Air Flotation, Alternating Pressure	General Hospital	Class 2	880.5550	1994-09-21
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2025-12-02
KIC	Cushion, Flotation	Physical Medicine	Class 1	890.3175	2025-07-22
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	1996-07-17

Official Correspondent

Chieh Yang

US Agent Details

Elsa Chu Business: WELLELL AMERICA CORP. Email: elsa.chu@wellell.com Phone: (714) 6713818

Related Public Records

Same Entity

Wellell Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
8043439	Wellell Inc.	NEW TAIPEI CITY, TW

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K170216	Tactile Systems Technology, Inc. (Dba Tactile Medical)	Flexitouch System	2017-05-26
K100306	Covidien	KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES	2010-05-04
K163485	Adherium (Nz), Ltd.	SmartTouch	2017-08-30
K781467	Travenol Laboratories, S.A.	U-FLOAT VALVE 2D9023	1978-09-07

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006339858. Last updated year: 2026. Please use registration number 3006339858 when referencing this establishment in official correspondence.