Data / Medical devices / United Kingdom / Actegy Ltd.

Actegy Ltd.: FDA-registered device maker in Bracknell, United Kingdom, 9 510(k) clearances

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

Actegy Ltd. is registered with the FDA (registration 3010078417) in Bracknell, United Kingdom. It lists 6 device types. The FDA files 9 510(k) clearances under its listings, the newest dated December 17, 2021. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3010078417
Address: The Lightbox Willoughby Road, Bracknell, United Kingdom, RG12 8FB
Owner or operator: Actegy Ltd. (10044804)
Roles: Specification developer
First device listed: July 31, 2013
Registered through: 2026
Brand names listed: REVITIVE

Devices it lists

Device	Product code	Class	Role	Source
Electrode, Cutaneous	GXY	2	Specification developer	accessdata.fda.gov
Stimulator, Electrical, Transcutaneous, For Arthritis	NYN	2	Specification developer	accessdata.fda.gov
Stimulator, Muscle, Powered	IPF	2	Specification developer	accessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle Conditioning	NGX	2	Specification developer	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain Relief	GZJ	2	Specification developer	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, Over-The-Counter	NUH	2	Specification developer	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
December 17, 2021	K210825	Revitive Medic Coach (Model Number 5575AQ)	NGX	Substantially Equivalent	Actegy , Ltd.	accessdata.fda.gov
August 31, 2021	K210448	Adhesive Electrode	GXY	Substantially Equivalent	Shaoxing Yingtuo Healthcare Co., Ltd.	accessdata.fda.gov
May 4, 2020	K192887	Revitive Medic Plus, Revitive Advanced 2	NGX	Substantially Equivalent	Actegy , Ltd.	accessdata.fda.gov
July 5, 2019	K190924	Revitive Medic Plus, Revitive Advanced 2	NGX	Substantially Equivalent	Actegy , Ltd.	accessdata.fda.gov
October 19, 2016	K160081	TENS Electrodes	GXY	Substantially Equivalent	Cathay Manufacturing Corp.	accessdata.fda.gov
March 31, 2016	K152480	Revitive Medic; Revitive MV; Revitive LV	NGX	Substantially Equivalent	Actegy , Ltd.	accessdata.fda.gov
March 23, 2015	K143207	Revitive IX (OTC)	NGX	Substantially Equivalent	Actegy , Ltd.	accessdata.fda.gov
November 22, 2013	K132588	ADHESIVE ELECTRODES	GXY	Substantially Equivalent	Top-Rank Health Care Equipment Co., Ltd.	accessdata.fda.gov
June 28, 2013	K123354	REVITIVE IX	IPF	Substantially Equivalent	Actegy , Ltd.	accessdata.fda.gov

Compare with other makers

Updated December 17, 2021. 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.