Data / Medical devices / China / Xiamen Senyang Co., Ltd

Xiamen Senyang Co., Ltd: FDA-registered device maker in Xiamen Fujian, China, 3 510(k) clearances

Name: Xiamen Senyang Co., Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Xiamen Senyang Co., Ltd is registered with the FDA (registration 3009955851) in Xiamen Fujian, China. It lists 8 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 23, 2020. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Xiamen Senyang Co., Ltd

FDA registration number: 3009955851
Address: No.189-1, Tongji South Road, Jimei District, Xiamen Fujian, China, 361000
Owner or operator: XIAMEN SENYANG CO., LTD (10042814)
Roles: Contract manufacturer, Exporter to the US, Manufacturer
First device listed: January 2, 2013
Registered through: 2026
Brand names listed: AIRFLOAT SEAT CUSHION: AF1717, AF1919, AF2822, Air Mattress:S01,ACM01,ACM02,AFM-100,AFM-200, Air Pump:P01S,P02,P06C,P06D,P08A,P08B,P08C,P08E,P08M, Air mattress: B01/B02;T01,T02,T03,T04,T05,T06,T07,T08,T09, Air pump:P01,P03,P05,P06A,P06B,P08,TKS2012,TKS02,TKS03,TKS05,P09, Anti-bedsore cushion: DC005,DC005P,DC006,DC006P,DC007,DC007P,DC008F,DC008P, NC501, Anti-bedsore cushion: NC502,NC503,NC504,NC505,NC801,NC802,NC803NC804,NC805, C01,C02, Full Alternating Pressure Pad System-LVA3058BLK, Full alternating Seat Cushion-CSH1084BLKFUL and more

Devices it lists

Device	Product code	Class	Role	Source
Adaptor, Hygiene	ILS	1	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Aid, Transfer	IKX	1	Contract manufacturer	accessdata.fda.gov
Cushion, Flotation	KIC	1	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Device, Transfer, Patient, Manual	FMR	1	Manufacturer	accessdata.fda.gov
Lift, Patient, Non-Ac-Powered	FSA	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Massager, Powered Inflatable Tube	IRP	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Mattress, Air Flotation, Alternating Pressure	FNM	2	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Mattress, Flotation Therapy, Non-Powered	IKY	1	Contract manufacturer, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 23, 2020	K192358	Pressure Therapy System PT1003	IRP	Substantially Equivalent	Xiamen Senyang Co., Ltd.	accessdata.fda.gov
February 19, 2019	K181409	Pressure Therapy System PT1003	IRP	Substantially Equivalent	Xiamen Senyang Co., Ltd.	accessdata.fda.gov
February 23, 2017	K161907	Pressure Therapy System	IRP	Substantially Equivalent	Xiamen Senyang Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated April 23, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.