| Device Classification Name |
Stimulator, Muscle, Powered, For Muscle Conditioning
|
| 510(k) Number |
K093999 |
| Device Name |
ARP POV SPORT |
| Applicant |
| Arp Manufacturing, Inc. |
| 4655 Kirkwood Court |
|
Boulder,
CO
80301
|
|
| Applicant Contact |
LEWIS WARD |
| Correspondent |
| Arp Manufacturing, Inc. |
| 4655 Kirkwood Court |
|
Boulder,
CO
80301
|
|
| Correspondent Contact |
LEWIS WARD |
| Regulation Number | 890.5850 |
| Classification Product Code |
|
| Date Received | 12/28/2009 |
| Decision Date | 08/10/2010 |
| 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
|
|
|