Power Wheelchair (D03, D05, D06, D09, D11, D16, D22, D23, D26, D36)
FDA 510(k) K242448 · Anhui Jbh Medical Apparatus Co., Ltd.
Submission
- Device name
- Power Wheelchair (D03, D05, D06, D09, D11, D16, D22, D23, D26, D36)
- Applicant
- Anhui Jbh Medical Apparatus Co., Ltd.
Chuzhou, CN - Received
- August 16, 2024
- Decision date
- January 2, 2025
- 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 |
| 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 |
|---|---|---|
| K251606 | Power Wheelchair (D26)ITI · Special | 06/25/2025SE |
| K241374 | Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009)IOR · Traditional | 02/28/2025SE |
| K242468 | Power Wheelchair (D10, D12, D15, D17, D20, D37)ITI · Traditional | 12/31/2024SE |
| 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 (D03, D05, D06, D09, D11, D16, D22, D23, D26, D36) cleared by the FDA?
Power Wheelchair (D03, D05, D06, D09, D11, D16, D22, D23, D26, D36) (K242448) received a 510(k) decision of Substantially Equivalent on January 2, 2025, 139 days after the submission was received.
What is the product code of K242448?
The FDA product code is ITI – Wheelchair, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.3860.