Device Classification Name |
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
|
510(k) Number |
K112351 |
Device Name |
ULTRA BEAUTY |
Applicant |
JOHARI DIGITAL HEALTHCARE, LTD. |
ELECTRONIC HARDWARE TECHNOLOGY |
PARK, G-582-584, E.P.I.P |
BORANADA, JODHPUR, RAJASTHAN,
IN
342008
|
|
Applicant Contact |
POOJA JOHARI |
Correspondent |
JOHARI DIGITAL HEALTHCARE, LTD. |
ELECTRONIC HARDWARE TECHNOLOGY |
PARK, G-582-584, E.P.I.P |
BORANADA, JODHPUR, RAJASTHAN,
IN
342008
|
|
Correspondent Contact |
POOJA JOHARI |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 08/16/2011 |
Decision Date | 03/30/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|