The following data is part of a premarket notification filed by Jace Systems, Inc. with the FDA for Jace Tri-stim Device.
Device ID | K931781 |
510k Number | K931781 |
Device Name: | JACE TRI-STIM DEVICE |
Classification | Stimulator, Muscle, Powered |
Applicant | JACE SYSTEMS, INC. 101 FOSTER RD. Moorestown, NJ 08057 |
Contact | Rick Rosati |
Correspondent | Rick Rosati JACE SYSTEMS, INC. 101 FOSTER RD. Moorestown, NJ 08057 |
Product Code | IPF |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-04-09 |
Decision Date | 1993-10-08 |