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 |