Device Classification Name |
stimulator, nerve, transcutaneous, for pain relief
|
510(k) Number |
K113544 |
Device Name |
ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGER |
Applicant |
PROSPERA CORPORATION |
405 BOULDER CT |
SUITE 500 |
PLEASANTON,
CA
94566
|
|
Applicant Contact |
Kevin Walls |
Correspondent |
PROSPERA CORPORATION |
405 BOULDER CT |
SUITE 500 |
PLEASANTON,
CA
94566
|
|
Correspondent Contact |
Kevin Walls |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 12/01/2011 |
Decision Date | 07/27/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|