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510(k) K210825

Revitive Medic Coach (Model Number 5575AQ) by Actegy , Ltd. — Product Code NGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2021
Date Received
March 19, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Muscle, Powered, For Muscle Conditioning
Device Class
Class II
Regulation Number
890.5850
Review Panel
PM
Submission Type

A powered muscle stimulator for muscle conditioning is a device used for other than medical purposes to apply an electrical current to electrodes on a person's skin to temporarily affect the stimulated muscle's contractile properties, force output, and/or fatigue resistance. Unlike the classified Powered Muscle Stimulator devices intended for use in physical medicine and rehabilitation, this device is not intended for use in patients with medical conditions and is intended only for muscle conditioning purposes.

Other clearances by Actegy , Ltd.

  • K192887 — Revitive Medic Plus, Revitive Advanced 2 (May 4, 2020)
  • K190924 — Revitive Medic Plus, Revitive Advanced 2 (July 5, 2019)
  • K152480 — Revitive Medic; Revitive MV; Revitive LV (March 31, 2016)
  • K143207 — Revitive IX (OTC) (March 23, 2015)
  • K140772 — AEROSURE MEDIC (December 19, 2014)
  • K123354 — REVITIVE IX (June 28, 2013)

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