| Device Classification Name |
Bed, Flotation Therapy, Powered
|
| 510(k) Number |
K882607 |
| Device Name |
ULTRAFLOTATION BED |
| Applicant |
| Medical Flotation Systems, Inc. |
| 104 Elden St., Suite 11 |
|
Herndon,
VA
22070
|
|
| Applicant Contact |
JACOBS, MD |
| Correspondent |
| Medical Flotation Systems, Inc. |
| 104 Elden St., Suite 11 |
|
Herndon,
VA
22070
|
|
| Correspondent Contact |
JACOBS, MD |
| Regulation Number | 890.5170 |
| Classification Product Code |
|
| Date Received | 06/24/1988 |
| Decision Date | 10/14/1988 |
| 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
|
|
|