The following data is part of a premarket notification filed by Medical Device Inspection Co., Inc. with the FDA for Thera-turn Cm-1000 Mattress Overlay System.
| Device ID | K931594 |
| 510k Number | K931594 |
| Device Name: | THERA-TURN CM-1000 MATTRESS OVERLAY SYSTEM |
| Classification | Bed, Flotation Therapy, Powered |
| Applicant | MEDICAL DEVICE INSPECTION CO., INC. 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11021 |
| Contact | Milton Beneke |
| Correspondent | Milton Beneke MEDICAL DEVICE INSPECTION CO., INC. 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11021 |
| Product Code | IOQ |
| CFR Regulation Number | 890.5170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-31 |
| Decision Date | 1993-12-21 |