The following data is part of a premarket notification filed by Jace Systems, Inc. with the FDA for Jace Model H440 Hand Cpm Device.
| Device ID | K931016 |
| 510k Number | K931016 |
| Device Name: | JACE MODEL H440 HAND CPM DEVICE |
| Classification | Exerciser, Finger, 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 | JFA |
| CFR Regulation Number | 890.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-26 |
| Decision Date | 1994-06-22 |