Clearance Summary
POWER SCOOTER, MODEL TL0821 received FDA 510(k) clearance under submission number K042011, sponsored by Teh Lin Prosthetic & Orthopaedic, 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 2004-09-24.
- Submission: K042011
- Applicant / Sponsor: Teh Lin Prosthetic & Orthopaedic, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3800
- Decision date: 2004-09-24
Classification & Regulation
This clearance is catalogued under FDA product code INI and 21 CFR 890.3800, within the Physical Medicine review panel as a Class II device.