Wu's Powered Wheelchair, Mambo F 120
FDA 510(k) K050011 · Wu'S Tech Co., Ltd.
510(k) numberK050011
Submission
- Device name
- Wu's Powered Wheelchair, Mambo F 120
- Applicant
- Wu'S Tech Co., Ltd.
Hsin-Chu City, TW - Received
- January 3, 2005
- Decision date
- February 11, 2005
- 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…
Other 510(k)s with product code ITI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260229 | Electric wheelchair (HC819N, HC830N, HC831N)ITI · Traditional | Yongkang Hengyi Vehicle Co., Ltd. | 09/08/2026SE |
| K260053 | Power Wheelchair (OS-R-M01I)ITI · Traditional | Beijing OrionStar Technology Co., Ltd. | 09/08/2026SE |
| K261354 | Electric wheelchair (D03)ITI · Traditional | Foshan Sowell Medical Technology Co., Ltd. | 08/21/2026SE |
| K261149 | Electric Wheelchair (DY611A-2, DY612A-1)ITI · Traditional | Zhejiang Lumbre Electric Appliance Co., Ltd. | 07/10/2026SE |
| K261396 | Electric WheelchairITI · Traditional | Ningbo Resshidi Medical Devices Co., Ltd. | 07/08/2026SE |
| K261164 | Electric wheelchair (XW-LY007 )ITI · Traditional | Yongkang Ruihe Metal Product Co., Ltd. | 07/07/2026SE |
| K260937 | Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK)ITI · Traditional | Shanghai Waylong Intelligent Technology Co.,Ltd | 06/24/2026SE |
| K253812 | Power Wheelchair (W5915B, W5915C, W5915D)ITI · Traditional | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 06/18/2026SE |
| K260335 | Electric Wheelchair (S500-6)ITI · Traditional | Zhongshan Sulenz Intelligent Technology Co., Ltd. | 06/15/2026SE |
| K261175 | WHILL (WHILL Model C2)ITI · Traditional | Whill, Inc. | 06/12/2026SE |
More from Whill, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K222729 | Electrical Scooter, WT-T4QP2INI · Traditional | 03/28/2023SE |
| K192308 | Wu's Electrical ScooterINI · Traditional | 12/21/2020SE |
| K181163 | Wu's Powered WheelchairITI · Traditional | 02/16/2019SE |
| K091212 | Wu's 3 Wheeled Electrical Scooter, WT-T3HINI · Traditional | 05/27/2009SE |
| K082963 | Wu's 4-WHEELED Neo Scooter, WT-M3AINI · Traditional | 11/24/2008SE |
| K072337 | Wu's 4-WHEELED Neo Scooter, Model WT-M4AINI · Traditional | 09/21/2007SE |
| K070655 | Wu's Powered Wheelchair, Mambo 36ITI · Traditional | 04/02/2007SE |
| K062790 | Wu's 3-WHEELED Neo Scooter, Model WT-T3EINI · Traditional | 10/11/2006SE |
| K052559 | Wu's Powered Wheelchair, Mambo 2ITI · Traditional | 09/26/2005SE |
| K050042 | Wu's 4-WHEELED Neo Scooter, WT-XL4INI · Traditional | 03/14/2005SE |
Questions and answers
When was Wu's Powered Wheelchair, Mambo F 120 cleared by the FDA?
Wu's Powered Wheelchair, Mambo F 120 (K050011) received a 510(k) decision of Substantially Equivalent on February 11, 2005, 39 days after the submission was received.
What is the product code of K050011?
The FDA product code is ITI – Wheelchair, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.3860.