Clearance Summary
POWER EXERCISE EQUIPMENT received FDA 510(k) clearance under submission number K874196, sponsored by Arc Motion , Ltd.. 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 1987-12-10.
- Submission: K874196
- Applicant / Sponsor: Arc Motion , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5380
- Decision date: 1987-12-10
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.