Clearance Summary
STANDARD WHEELCHAIR received FDA 510(k) clearance under submission number K963301, sponsored by L & M Resource Information Service, Inc.. 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 1996-10-23.
- Submission: K963301
- Applicant / Sponsor: L & M Resource Information Service, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3850
- Decision date: 1996-10-23
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.