Device Classification Name |
Stimulator, Nerve, Transcutaneous, Over-The-Counter
|
510(k) Number |
K130150 |
Device Name |
TCM MASSAGER |
Applicant |
ANHUI JINJIANQIAO MED-TECH CO,. LTD. |
05C.FUHAI KANGLE BUILDING |
NANSHAN DISTRICT SHENZHEN |
SHENZHEN, GUANGDONG,
CN
518000
|
|
Applicant Contact |
FIELD FU |
Correspondent |
ANHUI JINJIANQIAO MED-TECH CO,. LTD. |
05C.FUHAI KANGLE BUILDING |
NANSHAN DISTRICT SHENZHEN |
SHENZHEN, GUANGDONG,
CN
518000
|
|
Correspondent Contact |
FIELD FU |
Regulation Number | 882.5890
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/22/2013 |
Decision Date | 09/26/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|