TTS2800

Stimulator, Nerve, Transcutaneous, For Pain Relief

HENLEY INTL.

The following data is part of a premarket notification filed by Henley Intl. with the FDA for Tts2800.

Pre-market Notification Details

Device IDK895161
510k NumberK895161
Device Name:TTS2800
ClassificationStimulator, Nerve, Transcutaneous, For Pain Relief
Applicant HENLEY INTL. 104 INDUSTRIAL BLVD., Sugar Land,  TX  77470
ContactErnest Henley
CorrespondentErnest Henley
HENLEY INTL. 104 INDUSTRIAL BLVD., Sugar Land,  TX  77470
Product CodeGZJ  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-08-22
Decision Date1989-10-30

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