Device Classification Name |
stimulator, muscle, powered, for muscle conditioning
|
510(k) Number |
K141921 |
FOIA Releasable 510(k) |
K141921
|
Device Name |
HIVOX SPOPAD EMS |
Applicant |
HIVOX BIOTEK, INC. |
5 F., NO. 123, Shingde Road |
San-chong District |
New Taipei City,
TW
24158
|
|
Applicant Contact |
Ke-Min Jen |
Correspondent |
HIVOX BIOTEK, INC. |
5 F., NO. 123, Shingde Road |
San-chong District |
New Taipei City,
TW
24158
|
|
Correspondent Contact |
Ke-Min Jen |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 07/16/2014 |
Decision Date | 01/16/2015 |
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
|
|
|