| Device Classification Name |
Massager, Powered Inflatable Tube
|
| 510(k) Number |
K852264 |
| Device Name |
EBI FOOT MASSAGING PUMP |
| Applicant |
| Electro-Biology, Inc. |
| 300 Fairfield Rd. |
|
Fairfield,
NJ
07006
|
|
| Applicant Contact |
ANTHONY C PARKES |
| Correspondent |
| Electro-Biology, Inc. |
| 300 Fairfield Rd. |
|
Fairfield,
NJ
07006
|
|
| Correspondent Contact |
ANTHONY C PARKES |
| Regulation Number | 890.5650 |
| Classification Product Code |
|
| Date Received | 05/24/1985 |
| Decision Date | 07/19/1985 |
| 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
|
|
|