The following data is part of a premarket notification filed by Verimed Holdings, Inc. with the FDA for Romas (range Of Motion Assessment System).
| Device ID | K922550 |
| 510k Number | K922550 |
| Device Name: | ROMAS (RANGE OF MOTION ASSESSMENT SYSTEM) |
| Classification | Goniometer, Ac-powered |
| Applicant | VERIMED HOLDINGS, INC. 1401 E. BROWARD BLVD. SUITE 200 Fort Lauderdale, FL 33301 |
| Contact | Christopher J Chase |
| Correspondent | Christopher J Chase VERIMED HOLDINGS, INC. 1401 E. BROWARD BLVD. SUITE 200 Fort Lauderdale, FL 33301 |
| Product Code | KQX |
| CFR Regulation Number | 888.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-29 |
| Decision Date | 1992-12-10 |