Teh Lin Power Scooter, Model TL-822

FDA 510(k)

Class II (US FDA 510(k))

510(k) K042012

by Teh Lin Prosthetic & Orthopaedic, Inc.

Identifiers

510(k) Number: K042012 FDA 510(k)
FDA Product Code: INI FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 890.3800 FDA 510(k)
Regulation Number: 890.3800 FDA 510(k)
Advisory Committee: Physical Medicine FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The Teh Lin Power Scooter, Model TL-822, is a motorized vehicle designed for indoor and outdoor mobility. It features a four-wheeled base, a seat, and hand controls located on the steering column that allow the rider to operate the device.

This battery-operated scooter is designed for individuals restricted to a seated position and is disassemblable for transport. It includes an onboard battery charger and is regulated under FDA 510(k) clearance K042012.

Frequently asked questions

What is the intended use of the Teh Lin Power Scooter, Model TL-822?

The Teh Lin Power Scooter, Model TL-822, is a motorized vehicle intended to provide mobility for individuals who are restricted to a seated position. It is suitable for both indoor and outdoor use.

Is the scooter portable or easy to transport?

The scooter is designed to be disassemblable, which allows for easier transport. It also includes an onboard battery charger to facilitate convenient battery maintenance.

What is the regulatory status of this device?

The Teh Lin Power Scooter, Model TL-822, is regulated under FDA 510(k) clearance K042012, which confirms it has been found substantially equivalent to other legally marketed devices.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: TEH LIN POWER SCOOTER, MODEL TL-822 - Innolitics, TEH LIN POWER SCOOTER, MODEL TL-822 by TEH LIN PROSTHETIC & ORTHOPAEDIC ..., K042012 FDA 510 (k) - TEH LIN POWER SCOOTER

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K042012	Class II	Active

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Manufacturer

Manufacturer: Teh Lin Prosthetic & Orthopaedic, Inc.

Sources (1)

FDA 510(k) K042012 24 fields · synced Oct 6, 2026