JACE MODEL PM-410 HAND CPM DEVICE

Exerciser, Finger, Powered

JACE SYSTEMS, INC.

The following data is part of a premarket notification filed by Jace Systems, Inc. with the FDA for Jace Model Pm-410 Hand Cpm Device.

Pre-market Notification Details

Device IDK921351
510k NumberK921351
Device Name:JACE MODEL PM-410 HAND CPM DEVICE
ClassificationExerciser, Finger, 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 CodeJFA  
CFR Regulation Number890.5410 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-03-19
Decision Date1992-05-04

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