The following data is part of a premarket notification filed by Imex Health, Inc. with the FDA for Rehabot-ym.
| Device ID | K890838 |
| 510k Number | K890838 |
| Device Name: | REHABOT-YM |
| Classification | Exerciser, Powered |
| Applicant | IMEX HEALTH, INC. 5672 ALMADEN EXPRESSWAY San Jose, CA 95118 |
| Contact | Dennis Gurski |
| Correspondent | Dennis Gurski IMEX HEALTH, INC. 5672 ALMADEN EXPRESSWAY San Jose, CA 95118 |
| Product Code | BXB |
| CFR Regulation Number | 890.5380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-21 |
| Decision Date | 1989-03-23 |