Clearance Summary
SUN-TENS PALM TYPE R5/COMPACT WIRELES M2 EMS SERIES received FDA 510(k) clearance under submission number K011913, sponsored by Sun-Rain System Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2001-10-26.
- Submission: K011913
- Applicant / Sponsor: Sun-Rain System Corp.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 2001-10-26
Classification & Regulation
This clearance is catalogued under FDA product code IPF and 21 CFR 890.5850, within the Physical Medicine review panel as a Class II device.