H-WAVE


Device Classification Name

stimulator, muscle, powered

510(k) Number K103738
Device Name H-WAVE
Applicant
ELECTRONIC WAVEFORM LABORATORY, INC.
16168 beach blvd., suite 232
huntington beach, 
CA 
92647

Applicant Contact ryan p heaney
Correspondent
ELECTRONIC WAVEFORM LABORATORY, INC.
16168 beach blvd., suite 232
huntington beach, 
CA 
92647

Correspodent Contact ryan p heaney
Regulation Number 890.5850
Classification Product Code
IPF  
Date Received 12/22/2010
Decision Date 06/01/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No