The following data is part of a premarket notification filed by Sun-rain System Corp. with the FDA for Sun-rain Ultrasonic Therapy, Su-100.
| Device ID | K024013 |
| 510k Number | K024013 |
| Device Name: | SUN-RAIN ULTRASONIC THERAPY, SU-100 |
| Classification | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat |
| Applicant | SUN-RAIN SYSTEM CORP. NO. 58, FU-CHIUN ST. Hsin-chu City, TW |
| Contact | R. Jen Ke-min |
| Correspondent | R. Jen Ke-min SUN-RAIN SYSTEM CORP. NO. 58, FU-CHIUN ST. Hsin-chu City, TW |
| Product Code | IMI |
| CFR Regulation Number | 890.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-04 |
| Decision Date | 2003-10-31 |