| Device Classification Name |
Bed, Patient Rotation, Powered
|
| 510(k) Number |
K954671 |
| Device Name |
THE FREEDOM BED |
| Applicant |
| Probed Medical Technologies, Inc. |
| 44325 Yale Rd. W. |
|
Chilliwack, B.C.,
CA
V2R 4H2
|
|
| Applicant Contact |
STEVE PLUMMER |
| Correspondent |
| Probed Medical Technologies, Inc. |
| 44325 Yale Rd. W. |
|
Chilliwack, B.C.,
CA
V2R 4H2
|
|
| Correspondent Contact |
STEVE PLUMMER |
| Regulation Number | 890.5225 |
| Classification Product Code |
|
| Subsequent Product Code |
|
| Date Received | 10/10/1995 |
| Decision Date | 04/01/1996 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Physical Medicine
|
| 510k Review Panel |
Physical Medicine
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|