| Device Classification Name |
Massager, Therapeutic, Electric
|
| 510(k) Number |
K944730 |
| Device Name |
MASSAGER |
| Applicant |
| North American Technical Services Corp. |
| 30 Northport Rd. |
|
Sound Beach,
NY
11789
|
|
| Applicant Contact |
RICHARD C LANZILLOTTO |
| Correspondent |
| North American Technical Services Corp. |
| 30 Northport Rd. |
|
Sound Beach,
NY
11789
|
|
| Correspondent Contact |
RICHARD C LANZILLOTTO |
| Regulation Number | 890.5660 |
| Classification Product Code |
|
| Date Received | 09/26/1994 |
| Decision Date | 02/14/1995 |
| Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
| 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
|
|
|