The following data is part of a premarket notification filed by Apex Medical Corp. with the FDA for Ms104a, Newmini Ii (ems-ii), Model Ap-101050t And Medtrim (ems-v), Model Ap-102050t.
| Device ID | K002336 |
| 510k Number | K002336 |
| Device Name: | MS104A, NEWMINI II (EMS-II), MODEL AP-101050T AND MEDTRIM (EMS-V), MODEL AP-102050T |
| Classification | Stimulator, Muscle, Powered |
| Applicant | APEX MEDICAL CORP. 10TH FLOOR, NO.31, LANE 169 KANG NING STREET Hsi-chih City, Taipei Hsien, TW |
| Contact | Daniel Lee |
| Correspondent | Daniel Lee APEX MEDICAL CORP. 10TH FLOOR, NO.31, LANE 169 KANG NING STREET Hsi-chih City, Taipei Hsien, TW |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-01 |
| Decision Date | 2001-07-27 |