Power Wheelchair (D10, D12, D15, D17, D20, D37)
FDA 510(k) K242468 · Anhui Jbh Medical Apparatus Co., Ltd.
Submission
- Device name
- Power Wheelchair (D10, D12, D15, D17, D20, D37)
- Applicant
- Anhui Jbh Medical Apparatus Co., Ltd.
Chuzhou, CN - Received
- August 20, 2024
- Decision date
- December 31, 2024
- 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
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|---|---|---|---|
| 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 |
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| 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 |
|---|---|---|
| K251606 | Power Wheelchair (D26)ITI · Special | 06/25/2025SE |
| K241374 | Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009)IOR · Traditional | 02/28/2025SE |
| K242448 | Power Wheelchair (D03, D05, D06, D09, D11, D16, D22, D23, D26, D36)ITI · Traditional | 01/02/2025SE |
| K242252 | Power WheelchairITI · Traditional | 12/27/2024SE |
| K241854 | Power WheelchairITI · Traditional | 10/04/2024SE |
| K212092 | Portable Folding Electric Wheelchair (Model: DC01)ITI · Traditional | 05/06/2022SE |
| K212090 | Electric ScooterINI · Traditional | 04/22/2022SE |
| K210302 | Disposable Medical maskFXX · Traditional | 05/14/2021SE |
Questions and answers
When was Power Wheelchair (D10, D12, D15, D17, D20, D37) cleared by the FDA?
Power Wheelchair (D10, D12, D15, D17, D20, D37) (K242468) received a 510(k) decision of Substantially Equivalent on December 31, 2024, 133 days after the submission was received.
What is the product code of K242468?
The FDA product code is ITI – Wheelchair, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.3860.