Device Classification Name |
stimulator, muscle, powered, for muscle conditioning
|
510(k) Number |
K192264 |
Device Name |
HIVOX Spopad EMS SP-911, SP-921 |
Applicant |
Hivox Biotek Inc. |
5F., No. 123, Xinde Rd. |
Sanchong Dist. |
New Taipei City,
TW
24158
|
|
Applicant Contact |
Marx Lee |
Correspondent |
Hivox Biotek Inc. |
5F., No. 123, Xinde Rd. |
Sanchong Dist. |
New Taipei City,
TW
24158
|
|
Correspondent Contact |
Marx Lee |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 08/21/2019 |
Decision Date | 11/08/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|