The following data is part of a premarket notification filed by Innovative Medical Engineering, Inc. with the FDA for Mark Iv Hand, Thumb And Wrist (cpm) Unit.
| Device ID | K894907 |
| 510k Number | K894907 |
| Device Name: | MARK IV HAND, THUMB AND WRIST (CPM) UNIT |
| Classification | Exerciser, Powered |
| Applicant | INNOVATIVE MEDICAL ENGINEERING, INC. 13402 S. PRAIRIE AVE. Hawthorne, CA 90250 |
| Contact | Len Katzin |
| Correspondent | Len Katzin INNOVATIVE MEDICAL ENGINEERING, INC. 13402 S. PRAIRIE AVE. Hawthorne, CA 90250 |
| Product Code | BXB |
| CFR Regulation Number | 890.5380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-01 |
| Decision Date | 1989-10-06 |