Clearance Summary
HEFFINGTON KNEE REST received FDA 510(k) clearance under submission number K862925, sponsored by Lex-Ton Orthopedics. 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 1986-08-14.
- Submission: K862925
- Applicant / Sponsor: Lex-Ton Orthopedics
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3750
- Decision date: 1986-08-14
Classification & Regulation
This clearance is catalogued under FDA product code INW and 21 CFR 890.3750, within the Physical Medicine review panel as a Class I device.