SPEMBLY 9000 & 9300

Stimulator, Nerve, Transcutaneous, For Pain Relief

SPEMBLY MEDICAL LTD.

The following data is part of a premarket notification filed by Spembly Medical Ltd. with the FDA for Spembly 9000 & 9300.

Pre-market Notification Details

Device IDK802063
510k NumberK802063
Device Name:SPEMBLY 9000 & 9300
ClassificationStimulator, Nerve, Transcutaneous, For Pain Relief
Applicant SPEMBLY MEDICAL LTD. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeGZJ  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-08-26
Decision Date1980-10-03

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