BIO-STIMULATOR, MODEL 400

Stimulator, Nerve, Transcutaneous, For Pain Relief

MED-WESTERN ELECTRONICS, INC.

The following data is part of a premarket notification filed by Med-western Electronics, Inc. with the FDA for Bio-stimulator, Model 400.

Pre-market Notification Details

Device IDK813100
510k NumberK813100
Device Name:BIO-STIMULATOR, MODEL 400
ClassificationStimulator, Nerve, Transcutaneous, For Pain Relief
Applicant MED-WESTERN ELECTRONICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGZJ  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-11-03
Decision Date1981-11-27

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.