MODEL HS-2 TENS DEVICE

Stimulator, Nerve, Transcutaneous, For Pain Relief

TECHNALITHICS LABORATORIES, INC.

The following data is part of a premarket notification filed by Technalithics Laboratories, Inc. with the FDA for Model Hs-2 Tens Device.

Pre-market Notification Details

Device IDK962951
510k NumberK962951
Device Name:MODEL HS-2 TENS DEVICE
ClassificationStimulator, Nerve, Transcutaneous, For Pain Relief
Applicant TECHNALITHICS LABORATORIES, INC. 7003 WOODWAY DR., SUITE 315 Waco,  TX  76712
Product CodeGZJ  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-07-26
Decision Date1997-08-06

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