Clearance Summary
HLE-1000 HIGH/LOW TREATMENT TABLE received FDA 510(k) clearance under submission number K883659, sponsored by Rich-Mar 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 1988-10-13.
- Submission: K883659
- Applicant / Sponsor: Rich-Mar Corp.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3760
- Decision date: 1988-10-13
Classification & Regulation
This clearance is catalogued under FDA product code INQ and 21 CFR 890.3760, within the Physical Medicine review panel as a Class I device.