Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K192264
Device Classification Name
Stimulator, Muscle, Powered, For Muscle Conditioning
More FDA Info for this Device
510(K) Number
K192264
Device Name
Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant
Hivox Biotek Inc.
5F., No. 123, Xinde Rd.
Sanchong Dist.
New Taipei City 24158 TW
Other 510(k) Applications for this Company
Contact
Marx Lee
Other 510(k) Applications for this Contact
Regulation Number
890.5850
More FDA Info for this Regulation Number
Classification Product Code
NGX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/21/2019
Decision Date
11/08/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact