SM TENS & PMS


Device Classification Name

stimulator, muscle, powered, for muscle conditioning

510(k) Number K121719
Device Name SM TENS & PMS
Applicant
HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED
room 1706, no. 128 songle rd
songjiang area
shanghai, 

CN

201600

Applicant Contact doris dong
Correspondent
HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED
room 1706, no. 128 songle rd
songjiang area
shanghai, 

CN

201600

Correspodent Contact doris dong
Regulation Number 890.5850
Classification Product Code
NGX  
Subsequent Product Code
NUH  
Date Received 06/11/2012
Decision Date 05/10/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

Physical Medicine

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No