| Device Classification Name |
Bed, Flotation Therapy, Powered
|
| 510(k) Number |
K893614 |
| Device Name |
AEROMAT MRS-1000 |
| Applicant |
| Integrated Therapy Products, Inc. |
| 4505 I-55 N. |
|
Jackson,
MS
39206
|
|
| Applicant Contact |
ROBERT MCKINNEY |
| Correspondent |
| Integrated Therapy Products, Inc. |
| 4505 I-55 N. |
|
Jackson,
MS
39206
|
|
| Correspondent Contact |
ROBERT MCKINNEY |
| Regulation Number | 890.5170 |
| Classification Product Code |
|
| Date Received | 05/10/1989 |
| Decision Date | 06/22/1989 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Physical Medicine
|
| 510k Review Panel |
Physical Medicine
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|