Revitive Medic Plus, Revitive Advanced 2

Stimulator, Muscle, Powered, For Muscle Conditioning

Actegy, Ltd.

The following data is part of a premarket notification filed by Actegy, Ltd. with the FDA for Revitive Medic Plus, Revitive Advanced 2.

Pre-market Notification Details

Device IDK190924
510k NumberK190924
Device Name:Revitive Medic Plus, Revitive Advanced 2
ClassificationStimulator, Muscle, Powered, For Muscle Conditioning
Applicant Actegy, Ltd. Reflex, Cain Road Bracknell,  GB Rg12 1hl
ContactLawrence Brookfield
CorrespondentCarmelina Allis
The Allis Law Firm, PLLC 2437 Bay Area Blvd. #30 Houston,  TX  77058
Product CodeNGX  
Subsequent Product CodeIPF
Subsequent Product CodeNUH
Subsequent Product CodeNYN
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-09
Decision Date2019-07-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10858058005143 K190924 000
10858058005181 K190924 000
10858058005235 K190924 000

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