APEX MEDICAL DIGITAL EMS TS1311, TS1312


Device Classification Name

stimulator, muscle, powered

510(k) Number K021754
Device Name APEX MEDICAL DIGITAL EMS TS1311, TS1312
Original Applicant
APEX MEDICAL CORP.
10th floor, no.31, lane 169
kang ning street
hsi-chih city, taipei hsien, 

TW

Original Contact alan chang
Regulation Number 890.5850
Classification Product Code
IPF  
Date Received 05/29/2002
Decision Date 06/28/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

Neurology

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No