BTL 799-2T

Stimulator, Muscle, Powered, For Muscle Conditioning

BTL Industries, Inc.

The following data is part of a premarket notification filed by Btl Industries, Inc. with the FDA for Btl 799-2t.

Pre-market Notification Details

Device IDK182106
510k NumberK182106
Device Name:BTL 799-2T
ClassificationStimulator, Muscle, Powered, For Muscle Conditioning
Applicant BTL Industries, Inc. 362 Elm Street Marlborough,  MA  01752
ContactDavid Chmel
CorrespondentDavid Chmel
BTL Industries, Inc. 362 Elm Street Marlborough,  MA  01752
Product CodeNGX  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-08-03
Decision Date2018-10-23
Summary:summary

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