Device Classification Name |
stimulator, nerve, transcutaneous, for pain relief
|
510(k) Number |
K060246 |
Device Name |
INFREX |
Applicant |
JOHARI DIGITAL HEALTHCARE LTD. |
7131 FARRALONE AVE, #48, |
CANOGA PARK,
CA
91303
|
|
Applicant Contact |
POOJA JOHARI |
Correspondent |
JOHARI DIGITAL HEALTHCARE LTD. |
7131 FARRALONE AVE, #48, |
CANOGA PARK,
CA
91303
|
|
Correspondent Contact |
POOJA JOHARI |
Regulation Number | 882.5890
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/31/2006 |
Decision Date | 05/05/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|