| Device Classification Name |
Stimulator, Electrical, Transcutaneous, For Arthritis
|
| 510(k) Number |
K073386 |
| Device Name |
JOINT STIM, MODEL 1000 |
| Applicant |
| Pain Management Technologies |
| 1340 Home Ave. , Bldg. A |
|
Akron,
OH
44310
|
|
| Applicant Contact |
JOSHUA LEFKOVITZ |
| Correspondent |
| Pain Management Technologies |
| 1340 Home Ave. , Bldg. A |
|
Akron,
OH
44310
|
|
| Correspondent Contact |
JOSHUA LEFKOVITZ |
| Regulation Number | 882.5890 |
| Classification Product Code |
|
| Date Received | 12/03/2007 |
| Decision Date | 07/30/2008 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Neurology
|
| 510k Review Panel |
Neurology
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|