The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Mobilimb-cpm Upper/lower Limb Device.
| Device ID | K823495 |
| 510k Number | K823495 |
| Device Name: | MOBILIMB-CPM UPPER/LOWER LIMB DEVICE |
| Classification | Exerciser, Powered |
| Applicant | SYNTHES (USA) 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BXB |
| CFR Regulation Number | 890.5380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-23 |
| Decision Date | 1983-01-21 |