MODELS TENS 7000, EMS 7500 AND TWIN STIM


Device Classification Name

stimulator, muscle, powered

510(k) Number K080661
Device Name MODELS TENS 7000, EMS 7500 AND TWIN STIM
Applicant
KOALATY PRODUCTS, INC.
845 aronson lake court
roswell, 
GA 
30075

Applicant Contact jay mansour
Regulation Number 890.5850
Classification Product Code
IPF  
Subsequent Product Code
GZJ  
Date Received 03/10/2008
Decision Date 03/24/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No