Clearance Summary
ROLL A BOUT WALKER received FDA 510(k) clearance under submission number K941301, sponsored by Roll A Bout 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 1994-05-02.
- Submission: K941301
- Applicant / Sponsor: Roll A Bout Corp.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3850
- Decision date: 1994-05-02
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.