Teh Lin Powered Wheelchair, Model MDG-201
FDA 510(k) K022696 · Teh Lin Prosthetic & Orthopaedic, Inc.
510(k) numberK022696
Submission
- Device name
- Teh Lin Powered Wheelchair, Model MDG-201
- Applicant
- Teh Lin Prosthetic & Orthopaedic, Inc.
Hsin Chu City, TW - Received
- August 13, 2002
- Decision date
- February 7, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ITI – Wheelchair, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.3860
- Specialty
- Physical Medicine
A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. FDA interprets mobility to persons restricted to a sitting position to mean the device type is intended to provide mobility to individuals who have mobility impairments and require an assistive device for mobility. NOTE: This type…
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| K261175 | WHILL (WHILL Model C2)ITI · Traditional | Whill, Inc. | 06/12/2026SE |
More from Whill, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K051118 | Model TL-360 Power ScooterINI · Traditional | 05/31/2005SE |
| K051116 | Model TL-560 Power ScooterINI · Traditional | 05/31/2005SE |
| K042012 | Teh Lin Power Scooter, Model TL-822INI · Traditional | 09/24/2004SE |
| K042011 | Power Scooter, Model TL0821INI · Traditional | 09/24/2004SE |
| K042010 | Power Scooter, Model TL-688INI · Traditional | 09/01/2004SE |
| K041752 | Teh Lin Powered Wheelchair, MDG-601ITI · Traditional | 08/05/2004SE |
| K022697 | Teh Lin Jupiter Power Chair, Model TL-320ITI · Traditional | 01/24/2003SE |
| K022698 | Scooter Mars Series, Model TL-588INI · Traditional | 12/02/2002SE |
Questions and answers
When was Teh Lin Powered Wheelchair, Model MDG-201 cleared by the FDA?
Teh Lin Powered Wheelchair, Model MDG-201 (K022696) received a 510(k) decision of Substantially Equivalent on February 7, 2003, 178 days after the submission was received.
What is the product code of K022696?
The FDA product code is ITI – Wheelchair, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.3860.