Device Classification Name |
stimulator, muscle, powered, for muscle conditioning
|
510(k) Number |
K062439 |
Device Name |
POWERTONE, MODEL PT-11 |
Applicant |
JOHARI DIGITAL HEALTHCARE, LTD. |
26540 W. AGOURA ROAD |
SUITE 230 |
CALABASES,
CA
91302
|
|
Applicant Contact |
NISHA JOHARI |
Correspondent |
JOHARI DIGITAL HEALTHCARE, LTD. |
26540 W. AGOURA ROAD |
SUITE 230 |
CALABASES,
CA
91302
|
|
Correspondent Contact |
NISHA JOHARI |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 08/21/2006 |
Decision Date | 01/08/2007 |
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
|
|
|