Electrically Powered Wheelchair, Joy Rider
FDA 510(k) K220156 · Tung Keng Enterprise Co., Ltd.
510(k) numberK220156
Submission
- Device name
- Electrically Powered Wheelchair, Joy Rider
- Applicant
- Tung Keng Enterprise Co., Ltd.
Taichung City, CN - Received
- January 19, 2022
- Decision date
- October 7, 2022
- 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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More from Whill, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K033240 | Be-Mobile 3-WHEELED Electric Scooter, Model DK S200INI · Traditional | 12/18/2003SE |
| K033220 | Be-Mobile 4-WHEELED Electric Scooter, Model DK S280INI · Traditional | 12/18/2003SE |
| K033239 | Be-Mobile 4-WHEELED Electric Scooter, Model DK S500INI · Traditional | 11/12/2003SE |
| K033219 | Be-Mobile 4-WHEELED Electric Scooter, Model DK S600INI · Traditional | 11/12/2003SE |
| K033241 | Be-Mobile 3-WHEELED Electric Scooter, Model DK S320INI · Traditional | 11/10/2003SE |
Questions and answers
When was Electrically Powered Wheelchair, Joy Rider cleared by the FDA?
Electrically Powered Wheelchair, Joy Rider (K220156) received a 510(k) decision of Substantially Equivalent on October 7, 2022, 261 days after the submission was received.
What is the product code of K220156?
The FDA product code is ITI – Wheelchair, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.3860.