THE FREEDOM BED
FDA 510(k) clearance K954671 · decided 1996-04-01
Clearance details
- K-number
- K954671
- Device name
- THE FREEDOM BED
- Applicant
- Probed Medical Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-10-10
- Decision date
- 1996-04-01
- Days to decision
- 174 days
- Clearance type
- Traditional
- Product code
- IKZ
- Device class
- 2
- Regulation number
- 890.5225
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Chilliwack, B.C., CA
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PRESSUREGUARD IV (K972486) | Span-America Medical Systems, Inc. | 1998-02-20 |
| RUMORS DYNAMIC AIR THERAPY UNIT (K972111) | Hill-Rom, Inc. | 1998-02-02 |
| CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM (K962788) | Gaymar Industries, Inc. | 1997-04-30 |
| PULMONEX DYNAMIC AIR THERAPY UNIT (K950756) | Hill-Rom, Inc. | 1995-05-30 |
| MODEL TURN Q PLUS AUTOMATIC TURNING MATTRESS WITH LOW AIR LOSS THERAPY (K950681) | Invacare Corp. | 1995-05-16 |
| THE CRADLE (K933964) | The Primal Energy Research Foundation | 1994-10-03 |
| OSCILLAIR 3000 LOW AIR LOSS KINETIC THERAPY BED (K923710) | Progressive Medical Technology, Inc. | 1993-03-22 |
| TURN EZ BED DEVICE (K922473) | Med-Ez, Inc. | 1992-09-09 |
| KUDO (POWERED ROTATION BED) (K905390) | Kinetic Concepts, Inc. | 1991-01-08 |
| ROTO REST; TRAUMA AND INTENSIVE CARE BED (K905113) | Ethos Medical Products , Ltd. | 1990-11-26 |
| KEANE MOBILITY BED (K873047) | Surgi-Med, Inc. | 1987-10-15 |
| EMERSON MOTION BED 6-MS & 6-ME (K842604) | J. H. Emerson Co. | 1984-07-20 |
Recalls involving this device
No recalls on record reference this clearance.