PULSAR #B SINGLE CHANNEL TENS-PULSAR D

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 Pulsar #b Single Channel Tens-pulsar D.

Pre-market Notification Details

Device IDK831950
510k NumberK831950
Device Name:PULSAR #B SINGLE CHANNEL TENS-PULSAR D
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 Received1983-06-15
Decision Date1983-08-01

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