Clearance Summary
SPLASH & GO II received FDA 510(k) clearance under submission number K955295, sponsored by Kid'S Wheel-Chairs. 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 1995-11-30.
- Submission: K955295
- Applicant / Sponsor: Kid'S Wheel-Chairs
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3850
- Decision date: 1995-11-30
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.