Clearance Summary
J & S WHEELCHAIRS MODELS 500, 500B, 502, 503, 504 AND 500T received FDA 510(k) clearance under submission number K951621, sponsored by J&S Associates. 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 1995-06-22.
- Submission: K951621
- Applicant / Sponsor: J&S Associates
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3850
- Decision date: 1995-06-22
Classification & Regulation
This clearance is catalogued under FDA product code IOR and 21 CFR 890.3850, within the Physical Medicine review panel as a Class I device.