HEARTWAY Electrically Powered Wheelchairs
FDA 510(k) K142731 · Heartway Medical Products Co., Ltd.
510(k) numberK142731
Submission
- Device name
- HEARTWAY Electrically Powered Wheelchairs
- Applicant
- Heartway Medical Products Co., Ltd.
Taichung City, TW - Received
- September 23, 2014
- Decision date
- February 27, 2015
- 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…
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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 |
|---|---|---|
| K220227 | Auto Folding Scooter, S21FINI · Traditional | 10/12/2022SE |
| K151656 | HEARTWAY Power Mobility ScooterINI · Traditional | 11/25/2015SE |
| K150998 | HEARTWAY Power Mobility ScooterINI · Traditional | 09/29/2015SE |
| K150987 | HEARTWAY Power Mobility Scooter, BRIO S19INI · Traditional | 09/22/2015SE |
| K142783 | HEARTWAY Electrically Powered Wheelchair P27ITI · Traditional | 06/12/2015SE |
| K132855 | Heartway Power Mobility ScooterINI · Traditional | 08/29/2014SE |
| K132856 | Heartway Power WheelchairITI · Traditional | 07/15/2014SE |
| K101143 | Heartway Power Mobility Scooter, S11INI · Traditional | 05/26/2010SE |
| K101142 | Heartway Lightweight Power Mobility Scooter, S34INI · Traditional | 05/26/2010SE |
| K100327 | Heartway Power Chair, P23ITI · Traditional | 03/22/2010SE |
Questions and answers
When was HEARTWAY Electrically Powered Wheelchairs cleared by the FDA?
HEARTWAY Electrically Powered Wheelchairs (K142731) received a 510(k) decision of Substantially Equivalent on February 27, 2015, 157 days after the submission was received.
What is the product code of K142731?
The FDA product code is ITI – Wheelchair, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.3860.