US-101L, US-103S


Device Classification Name

ultrasonic diathermy for use in applying therapeutic deep heat

510(k) Number K112520
Device Name US-101L, US-103S
Applicant
ITO CO., LTD.
3-3-3 toyotama-minami
nerima-ku
tokyo, 

JP

176-0014

Applicant Contact haruhisa okada
Regulation Number 890.5300
Classification Product Code
IMI  
Date Received 08/31/2011
Decision Date 10/26/2011
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