Clearance Summary
HEALTHMASTER- MODEL 8320 MOTORIZED TREADMILL received FDA 510(k) clearance under submission number K844779, sponsored by Roadmaster 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 1985-06-28.
- Submission: K844779
- Applicant / Sponsor: Roadmaster Corp.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5380
- Decision date: 1985-06-28
Classification & Regulation
This clearance is catalogued under FDA product code BXB and 21 CFR 890.5380, within the Physical Medicine review panel as a Class I device.