Clearance Summary
RE-HEATER, HOT PACK received FDA 510(k) clearance under submission number K863654, sponsored by K & L Ent.. 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 1986-10-23.
- Submission: K863654
- Applicant / Sponsor: K & L Ent.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5700
- Decision date: 1986-10-23
Classification & Regulation
This clearance is catalogued under FDA product code IME and 21 CFR 890.5700, within the Physical Medicine review panel as a Class I device.