NeoWave Pain Relief And Recovery System, Model# T16-2020

Massager, Powered Inflatable Tube

Eva Medtec, Inc

The following data is part of a premarket notification filed by Eva Medtec, Inc with the FDA for Neowave Pain Relief And Recovery System, Model# T16-2020.

Pre-market Notification Details

Device IDK202693
510k NumberK202693
Device Name:NeoWave Pain Relief And Recovery System, Model# T16-2020
ClassificationMassager, Powered Inflatable Tube
Applicant Eva Medtec, Inc 6300 W. Old Shakopee Road, Suite 140 Bloomington,  MN  55438
ContactIrene Waldridge
CorrespondentIrene Waldridge
Eva Medtec, Inc 6300 W. Old Shakopee Road, Suite 140 Bloomington,  MN  55438
Product CodeIRP  
CFR Regulation Number890.5650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-15
Decision Date2021-03-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
G067T1620200 K202693 000
G067A001500 K202693 000

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