Device Classification Name |
Stimulator, Nerve, Transcutaneous, For Pain Relief
|
510(k) Number |
K081835 |
Device Name |
ACTICARE IC AND TSE |
Applicant |
BIOINDUCTION LIMITED |
2300 MCDERMOTT ROAD |
SUITE 200-207 |
PLANO,
TX
75025
|
|
Applicant Contact |
KRISTA OAKES |
Correspondent |
BIOINDUCTION LIMITED |
2300 MCDERMOTT ROAD |
SUITE 200-207 |
PLANO,
TX
75025
|
|
Correspondent Contact |
KRISTA OAKES |
Regulation Number | 882.5890
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/27/2008 |
Decision Date | 03/19/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|