Electrically Powered Wheelchair, Joy Rider— 510(k) K220156
Substantially EquivalentTung Keng Enterprise Co., Ltd.
FDA 510(k) clearance K220156 for Electrically Powered Wheelchair, Joy Rider, Substantially Equivalent on 2022-10-07. Applicant: Tung Keng Enterprise Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Tung Keng Enterprise Co., Ltd.
- Product code
- Code ITI
- Device class
- Class 2
- Regulation
- 21 CFR 890.3860
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Taichung City, CN
Recent devices under product code ITI
view allMore clearances from Tung Keng Enterprise Co., Ltd.
view all- K033220 — BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S280
- K033240 — BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S200
- K033219 — BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S600
- K033239 — BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S500
- K033241 — BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S320
Adverse events under product code ITI
product code ITI- Death
- 34
- Injury
- 778
- Malfunction
- 1,085
- Other
- 1
- Total
- 1,898
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.