Device Classification Name
|
STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF
|
Regulation Number
|
882.5890
|
510(k) Number
|
K896948
|
Device Name
|
"ALPHA-STIM CS"
|
Applicant
|
ELECTROMEDICAL PRODUCTS, INC.
|
12591 CRENSHAW BLVD
|
HAWTHORNE, CA 90250
|
|
Contact
|
L KIRSCH
|
Product Code
|
GZJ
|
Date Received
|
12/13/1989
|
Decision Date
|
02/23/1990
|
Decision
|
SUBSTANTIALLY EQUIVALENT (SE)
|
Classification Advisory Committee
|
Neurology
|
Review Advisory Committee
|
Neurology
|
Statement/Summary/Purged Status
|
Purged, no summary or statement
|
Type
|
Traditional
|
Reviewed by Third Party
|
No
|