. Hpm-6000 510(k) FDA Premarket Notification K160992 BTL INDUSTRIES, INC.
Hpm-6000 510(k) FDA Premarket Notification K160992 BTL INDUSTRIES, INC.
Hpm-6000 510(k) FDA Premarket Notification K160992 BTL INDUSTRIES, INC.

HPM-6000

The following data is part of a premarket notification filed by Btl Industries, Inc. with the FDA for Hpm-6000.

Pre-market Notification Details Device IDK160992510k NumberK160992Device Name:HPM-6000ClassificationStimulator, Muscle, PoweredApplicant BTL INDUSTRIES, INC. 47 LORING DRIVE Framingham, MA 01702 ContactJan ZarskyCorrespondentJan Zarsky BTL INDUSTRIES, INC. 47 LORING DRIVE Framingham, MA 01702 Product CodeIPF CFR Regulation Number890.5850 [🔎]DecisionSubstantially Equivalent (SESE)TypeTraditional3rd Party ReviewedNoCombination ProductNoDate Received2016-04-08Decision Date2016-10-21Summary:summary

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