MODELS EMS 5.0, EMS 5.1


Device Classification Name

stimulator, muscle, powered

510(k) Number K072795
Device Name MODELS EMS 5.0, EMS 5.1
Applicant
KOALATY PRODUCTS, INC.
5015 n. clark ave.
tampa, 
FL 
33614

Applicant Contact jeff lenoir
Regulation Number 890.5850
Classification Product Code
IPF  
Date Received 10/01/2007
Decision Date 11/27/2007
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