Device Classification Name |
stimulator, muscle, powered, for muscle conditioning
|
510(k) Number |
K130723 |
Device Name |
FDES106 MINI TENS&EMS DEVICE,FDES106 MULTI-FUNCTION MINI TENS&EMS DEVICE,FDES105 PAIN RELIEF PLASTER,FDES107 ABDOMINAL |
Applicant |
FAMIDOC TECHNOLOGY CO., LTD |
No.212 Yilong Road, Hexi Industrial Zone, Jinxia, |
Changan Town |
Dongguan,
CN
523853
|
|
Applicant Contact |
REANNY WANG |
Correspondent |
FAMIDOC TECHNOLOGY CO., LTD |
No.212 Yilong Road, Hexi Industrial Zone, Jinxia, |
Changan Town |
Dongguan,
CN
523853
|
|
Correspondent Contact |
REANNY WANG |
Regulation Number | 890.5850
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/18/2013 |
Decision Date | 02/07/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|