510(k) K950681
- Device
- MODEL TURN Q PLUS AUTOMATIC TURNING MATTRESS WITH LOW AIR LOSS THERAPY
- Applicant
- INVACARE CORP.
- 510(k) number
- K950681
- Product code
- IKZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-05-16
- Date received
- 1995-02-14
- Regulation
- 890.5225
- Classification name
- Bed, Patient Rotation, Powered
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- EDWARD A KROLL
- Address
- 899 Cleveland St. P.O. Box 4028 Elyria OH US 44036 44036
FDA Registration Numbers#
- 3040337865
- 3006891315
- 3007420694
- 2032121
- 3005179379
- 3016947689
- 2030732
- 3013846070
- 8044130
- 3009591865
- 3002798200
- 3018115441
- 9681684
- 1831750
- 1931307
- 3030492371
- 1954156
- 1043644
- 3038008630
- 3015423385
Source Documents#
Other 510(k) Records For Product Code IKZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K972486 | PRESSUREGUARD IV | Span-America Medical Systems, Inc. | 1998-02-20 |
| K972111 | RUMORS DYNAMIC AIR THERAPY UNIT | Hill-Rom, Inc. | 1998-02-02 |
| K962788 | CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM | Gaymar Industries, Inc. | 1997-04-30 |
| K954671 | THE FREEDOM BED | Probed Medical Technologies, Inc. | 1996-04-01 |
| K950756 | PULMONEX DYNAMIC AIR THERAPY UNIT | Hill-Rom, Inc. | 1995-05-30 |
| K933964 | THE CRADLE | The Primal Energy Research Foundation | 1994-10-03 |
| K923710 | OSCILLAIR 3000 LOW AIR LOSS KINETIC THERAPY BED | Progressive Medical Technology, Inc. | 1993-03-22 |
| K922473 | TURN EZ BED DEVICE | Med-Ez, Inc. | 1992-09-09 |
| K905390 | KUDO (POWERED ROTATION BED) | Kinetic Concepts, Inc. | 1991-01-08 |
| K905113 | ROTO REST; TRAUMA AND INTENSIVE CARE BED | Ethos Medical Products , Ltd. | 1990-11-26 |
| K873047 | KEANE MOBILITY BED | Surgi-Med, Inc. | 1987-10-15 |
| K842604 | EMERSON MOTION BED 6-MS & 6-ME | J. H. Emerson Co. | 1984-07-20 |
| K834563 | EGERTON TURNING & TILTING BED | Kinetic Concepts, Inc. | 1984-01-30 |
| K823095 | KINETIC MOTION BED | Motion Manufacturers, Inc. | 1982-12-03 |
| K822402 | ROTO REST KINETIC TREATMENT TABLE PEDIA | Kinetic Concepts, Inc. | 1982-10-22 |
Legacy Summary#
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FDA Review#
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