The following data is part of a premarket notification filed by Ormed Mfg., Inc. with the FDA for Artromot K2 Cpm.
| Device ID | K931555 |
| 510k Number | K931555 |
| Device Name: | ARTROMOT K2 CPM |
| Classification | Exerciser, Powered |
| Applicant | ORMED MFG., INC. 1000 BURNETT AVE. SUITE 250 Concord, CA 94520 |
| Contact | David Schlerf |
| Correspondent | David Schlerf ORMED MFG., INC. 1000 BURNETT AVE. SUITE 250 Concord, CA 94520 |
| Product Code | BXB |
| CFR Regulation Number | 890.5380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-30 |
| Decision Date | 1994-01-31 |