Clearance Summary
HOMECARE CLINICS INFRAHEAT #230 received FDA 510(k) clearance under submission number K854151, sponsored by Nelkin/Piper Intl.. 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 1986-01-30.
- Submission: K854151
- Applicant / Sponsor: Nelkin/Piper Intl.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5500
- Decision date: 1986-01-30
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.