The following data is part of a premarket notification filed by Sun-rain System Corp. with the FDA for Sun-tens Palm Type R5/compact Wireles M2 Ems Series.
| Device ID | K011913 |
| 510k Number | K011913 |
| Device Name: | SUN-TENS PALM TYPE R5/COMPACT WIRELES M2 EMS SERIES |
| Classification | Stimulator, Muscle, Powered |
| Applicant | SUN-RAIN SYSTEM CORP. NO. 58, FU-CHIUN ST. Hsin-chu City, TW |
| Contact | Yang Tien-hising |
| Correspondent | Yang Tien-hising SUN-RAIN SYSTEM CORP. NO. 58, FU-CHIUN ST. Hsin-chu City, TW |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-19 |
| Decision Date | 2001-10-26 |