TRIOWAVE TECHNOLOGIES

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Stimulator, Nerve, Transcutaneous, Over-The-Counter (NUH) (1)

Premarket Exempt

Clear

PainKARE - 00866946000302 Catalog Number :

Device Description : PainKARE is an OTC medical device intended to temporarily relieve pain due to st PainKARE is an OTC medical device intended to temporarily relieve pain due to strain from exercise or normal household work or activities via electro-therapy. The Device consists two Stimulator pads connected by a USB cable for Electrotherapy.'' PainKARE’s Stimulator pads operate in a programmable micro-current mode and deliver Biphasic waveforms which in turn provide electrical stimulation to the body that aids in relieving pain.

Device Class : 2

Duns Number: 080195601

Premarket Exempt : No

Product Code : NUH

Prescription Use : No

Device Count : 1

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