# K042011: Power Scooter, Model TL0821

- Pathway: 510(k) (Traditional)
- Applicant: Teh Lin Prosthetic & Orthopaedic, Inc.
- Decided: Sep 24, 2004 after 60 days
- Product code: INI (Vehicle, Motorized 3-Wheeled)
- Device class: 2
- Regulation: 21 CFR 890.3800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K022698 (2002). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022698: Scooter Mars Series, Model TL-588, Teh Lin Prosthetic & Orthopaedic, Inc. (2002) Summary page 1.

## Most influential descendants
- K051118: Model TL-360 Power Scooter (2005), 0 descendants of its own
- K051116: Model TL-560 Power Scooter (2005), 0 descendants of its own

## Indications for use
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.

Source page: https://510kreport.com/device/K042011
Methodology: https://510kreport.com/methodology