The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Model Turn Q Plus Automatic Turning Mattress With Low Air Loss Therapy.
| Device ID | K950681 |
| 510k Number | K950681 |
| Device Name: | MODEL TURN Q PLUS AUTOMATIC TURNING MATTRESS WITH LOW AIR LOSS THERAPY |
| Classification | Bed, Patient Rotation, Powered |
| Applicant | INVACARE CORP. 899 CLEVELAND ST. P.O. BOX 4028 Elyria, OH 44036 |
| Contact | Edward A Kroll |
| Correspondent | Edward A Kroll INVACARE CORP. 899 CLEVELAND ST. P.O. BOX 4028 Elyria, OH 44036 |
| Product Code | IKZ |
| CFR Regulation Number | 890.5225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-14 |
| Decision Date | 1995-05-16 |