EA STIMULATOR


Device Classification Name

stimulator, nerve, transcutaneous, for pain relief

510(k) Number K080221
Device Name EA STIMULATOR
Applicant
HELIO MEDICAL SUPPLIES, INC.
606 charcot ave.
san jose, 
CA 
95131

Applicant Contact yukuo hso
Correspondent
HELIO MEDICAL SUPPLIES, INC.
606 charcot ave.
san jose, 
CA 
95131

Correspodent Contact yukuo hso
Regulation Number 882.5890
Classification Product Code
GZJ  
Date Received 01/29/2008
Decision Date 09/09/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No