Sun-Rain Ultrasonic Therapy, SU-100

FDA 510(k) K024013 · Sun-Rain System Corp.

Substantially Equivalent

510(k) numberK024013

Submission

Device name
Sun-Rain Ultrasonic Therapy, SU-100
Applicant
Sun-Rain System Corp.
Hsin-Chu City, TW
Received
December 4, 2002
Decision date
October 31, 2003
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
IMI – Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5300
Specialty
Physical Medicine

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More from Shenzhen Dongdixin Technology Co., Ltd.

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Questions and answers

When was Sun-Rain Ultrasonic Therapy, SU-100 cleared by the FDA?

Sun-Rain Ultrasonic Therapy, SU-100 (K024013) received a 510(k) decision of Substantially Equivalent on October 31, 2003, 331 days after the submission was received.

What is the product code of K024013?

The FDA product code is IMI – Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat, a Class II (moderate risk) device regulated under 21 CFR 890.5300.