Clearance Summary
PRECISION TDP, HEAT AND INFRARED LAMPS AND MARVEL AND WONDER LAMPS received FDA 510(k) clearance under submission number K081720, sponsored by Prime Herbs Corporation. 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 2009-06-16.
- Submission: K081720
- Applicant / Sponsor: Prime Herbs Corporation
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5500
- Decision date: 2009-06-16
Classification & Regulation
This clearance is catalogued under FDA product code ILY and 21 CFR 890.5500, within the Physical Medicine review panel as a Class II device.