Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009955851

FEI Number

3009955851

Entity Name

XIAMEN SENYANG CO., LTD

City/State/Country

Xiamen Fujian, CN

Establishment Address

No.189-1, Tongji South Road, Jimei District, Xiamen Fujian 361000, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

XIAMEN SENYANG CO., LTD (Owner Number: 10042814)

Owner / Operator Contact Address

No.189-1, Tongji South Road, Jimei District, Xiamen, CN-FJ 361000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Stand Assist Seat (SKU:CSH1106) Pressure Therapy System, PT1002 Anti-bedsore cushion: NC502,NC503,NC504,NC505,NC801,NC802,NC803NC804,NC805, C01,C02 Anti-bedsore cushion: DC005,DC005P,DC006,DC006P,DC007,DC007P,DC008F,DC008P, NC501 AIRFLOAT SEAT CUSHION: AF1717, AF1919, AF2822 Pressure Therapy System PT1003 (OTC) Tansfer Mattress (with built-in inflation pump) Powered Nursing transfer lifts BMW01 BMW02 BMW03 BMW05 BMW06 BMW07 BMW09 Manual Nursing Transfer lifts BMW08 Pressure Therapy System PT1003

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2020-01-08
IRP	Massager, Powered Inflatable Tube	Physical Medicine	Class 2	890.5650	2017-03-06
KIC	Cushion, Flotation	Physical Medicine	Class 1	890.3175	2015-12-20
IRP	Massager, Powered Inflatable Tube	Physical Medicine	Class 2	890.5650	2020-08-19
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2024-01-03
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	Class 1	880.5510	2025-02-25
IRP	Massager, Powered Inflatable Tube	Physical Medicine	Class 2	890.5650	2019-03-14
IKY	Mattress, Flotation Therapy, Non-Powered	General Hospital	Class 1	880.5150	2023-09-22

Official Correspondent

Chunshui Ma

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

XIAMEN SENYANG CO., 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
K242140	Jiale Health Technology Shenzhen Co., Ltd.	Air Compression Leg Massager (K-705)	2025-03-17

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 3009955851. Last updated year: 2026. Please use registration number 3009955851 when referencing this establishment in official correspondence.