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Excelhealth Inc.: FDA-registered device maker in Colleyville, TX, United States, 9 510(k) clearances

Name: Excelhealth Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Excelhealth Inc. is registered with the FDA (registration 3010632563) in Colleyville, TX, United States. It lists 5 device types. The FDA files 9 510(k) clearances under its listings, the newest dated November 21, 2018. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3010632563
Address: 1904 Industrial Blvd Ste 106, Colleyville, TX, United States, 76034
Owner or operator: ExcelHealth Inc. (10045721)
Roles: Repackager or relabeler
First device listed: December 19, 2013
Registered through: 2026
Brand names listed: PlayMakar PRO Wireless Muscle Stimulator PRO-1000, PRO-1000-2, PlayMakar Sport Muscle Stimulator, PRO-500, Pre-Gelled Butterfly Electrode Pads, 3.5" x 5", ET-7171, B0148U5E44, Pre-Gelled Butterfly Electrode Pads, 3.5" x 5", ET-7272-5, B07D3CDSQ8, Pre-Gelled Oval Electrode Pads, 3"x 5", ET-5454, B074ZDVYYN, Pre-Gelled Square Electrode Pads, 2" x 2", CM5050-4, B00MEO7U80, Pre-Gelled Square Electrode Pads, 2" x 2", Pre-Gelled Butterfly 3.5" x 5", ET-8484, B07K8YQ5C7, Pre-Gelled Square Electrode Pads, 2.75" x 2.75" ET-5153-S, B0DT1QFWFT and more

Devices it lists

Device	Product code	Class	Role	Source
Electrode, Cutaneous	GXY	2	Repackager or relabeler	accessdata.fda.gov
Lamp, Infrared, Therapeutic Heating	ILY	2	Repackager or relabeler	accessdata.fda.gov
Stimulator, Electrical, Transcutaneous, For Arthritis	NYN	2	Repackager or relabeler	accessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle Conditioning	NGX	2	Repackager or relabeler	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, Over-The-Counter	NUH	2	Repackager or relabeler	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
November 21, 2018	K182581	PlayMakar Sport Muscle Stimulator, Model PRO-500	NUH	Substantially Equivalent	Playmakar, Inc.	accessdata.fda.gov
October 18, 2017	K172809	OTC Combo TENS/EMS System	NUH	Substantially Equivalent	Well-Life Healthcare Limited	accessdata.fda.gov
December 5, 2016	K161453	WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A	NUH	Substantially Equivalent	Well-Life Healthcare Limited	accessdata.fda.gov
November 14, 2014	K141299	OTC COMBO TENS/EMS SYSTEM	NUH	Substantially Equivalent	Well-Life Healthcare Limited	accessdata.fda.gov
November 22, 2013	K132588	ADHESIVE ELECTRODES	GXY	Substantially Equivalent	Top-Rank Health Care Equipment Co., Ltd.	accessdata.fda.gov
September 7, 2012	K121353	MINI PATCH	NUH	Substantially Equivalent	Well-Life Healthcare Limited	accessdata.fda.gov
February 5, 2010	K091757	OTC TENS FOR ARM AND LEG PAIN RELIEF, MODEL WL-2407	NUH	Substantially Equivalent	Well-Life Healthcare Limited	accessdata.fda.gov
April 10, 2009	K082065	WELL LIFE SELF ADHESIVE ELECTRODE / MODELS: CM, FA, PU AND SP	GXY	Substantially Equivalent	Well-Life Healthcare Limited	accessdata.fda.gov
February 7, 2007	K063660	OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2407	NUH	Substantially Equivalent	Well-Life Healthcare Limited	accessdata.fda.gov

Compare with other makers

Updated November 21, 2018. 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.