Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K052785
Device Classification Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
More FDA Info for this Device
510(K) Number
K052785
Device Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant
WELL-LIFE HEALTHCARE LIMITED
5 FL., STE 504,EMPIRE CENTRE
68 MODY ROAD, TSIMSHATSUIM
KOWLOON HK
Other 510(k) Applications for this Company
Contact
GRACE CHANG
Other 510(k) Applications for this Contact
Regulation Number
882.5890
More FDA Info for this Regulation Number
Classification Product Code
NUH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/03/2005
Decision Date
03/17/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact