Electric Wheelchair (MP148)
FDA 510(k) K253870 · Suzhou Master Machinery Manufacturing Co.,Ltd
510(k) numberK253870
Submission
- Device name
- Electric Wheelchair (MP148)
- Applicant
- Suzhou Master Machinery Manufacturing Co.,Ltd
Kunshan, CN - Received
- December 4, 2025
- Decision date
- March 4, 2026
- 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 |
|---|---|---|
| K252687 | Manual Wheelchair (HM305-Air1, HM305-Air2)IOR · Traditional | 11/21/2025SE |
| K251638 | Mobility Scooter (MS160C)INI · Traditional | 07/22/2025SE |
| K242982 | Mobility Scooter (MS160A)INI · Traditional | 01/31/2025SE |
| K241463 | Electric Wheelchair (MP201C); Electric Wheelchair (MP201L)ITI · Traditional | 07/18/2024SE |
| K222711 | HS186B ScooterINI · Traditional | 01/09/2023SE |
Questions and answers
When was Electric Wheelchair (MP148) cleared by the FDA?
Electric Wheelchair (MP148) (K253870) received a 510(k) decision of Substantially Equivalent on March 4, 2026, 90 days after the submission was received.
What is the product code of K253870?
The FDA product code is ITI – Wheelchair, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.3860.