JACE TRI-STIM DEVICE

Stimulator, Muscle, Powered

JACE SYSTEMS, INC.

The following data is part of a premarket notification filed by Jace Systems, Inc. with the FDA for Jace Tri-stim Device.

Pre-market Notification Details

Device IDK931781
510k NumberK931781
Device Name:JACE TRI-STIM DEVICE
ClassificationStimulator, Muscle, Powered
Applicant JACE SYSTEMS, INC. 101 FOSTER RD. Moorestown,  NJ  08057
ContactRick Rosati
CorrespondentRick Rosati
JACE SYSTEMS, INC. 101 FOSTER RD. Moorestown,  NJ  08057
Product CodeIPF  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-04-09
Decision Date1993-10-08

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.