Device Classification Name |
Stimulator, Nerve, Transcutaneous, For Pain Relief
|
510(k) Number |
K062641 |
Device Name |
BODY-STIM, BIOMODULATOR, BEST-RSI, BEST PRO, MODEL BEST-AV1 |
Applicant |
AVAZZIA, INC. |
13154 COIT RD., STE. 200 |
DALLAS,
TX
75240
|
|
Applicant Contact |
CATHERINE TONE |
Correspondent |
AVAZZIA, INC. |
13154 COIT RD., STE. 200 |
DALLAS,
TX
75240
|
|
Correspondent Contact |
CATHERINE TONE |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 09/06/2006 |
Decision Date | 04/30/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|