Clearance Summary
TAIWAN KING STRONG TC 04 MECHANICALWHEELCHAIR received FDA 510(k) clearance under submission number K042652, sponsored by Taiwan King Strong Co., 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 2004-11-04.
- Submission: K042652
- Applicant / Sponsor: Taiwan King Strong Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3850
- Decision date: 2004-11-04
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.