Electric Wheelchair (Model: S7110)
FDA 510(k) K200978 · Dongguan Prestige Sporting Goods Co., Ltd.
510(k) numberK200978
Submission
- Device name
- Electric Wheelchair (Model: S7110)
- Applicant
- Dongguan Prestige Sporting Goods Co., Ltd.
Dongguan, CN - Received
- April 13, 2020
- Decision date
- April 16, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K190737 | Solax Electric Scooter (Models: S204311M, S204161, S204143)INI · Traditional | 05/10/2021SE |
| K192190 | Solax Electric ScooterINI · Traditional | 04/23/2021SE |
| K202632 | Electric wheelchair (S7204/S7205)ITI · Traditional | 04/08/2021SE |
| K201508 | Infrared ThermometerFLL · Traditional | 03/09/2021SE |
| K202549 | Solax Electric Scooter (Model: S202261B)INI · Traditional | 02/26/2021SE |
| K191897 | Solax Electric Scooter (Models: S3023, S3024, S3025, S3026)INI · Traditional | 02/10/2021SE |
| K200857 | Electric wheelchair (Model: S7012)ITI · Traditional | 12/17/2020SE |
| K182400 | Solax Powered Wheelchair (Models: S7101, S7103)ITI · Traditional | 04/14/2020SE |
| K182576 | Solax Powered WheelchairITI · Traditional | 05/21/2019SE |
| K172440 | Solax Electric Scooter, Models: S302121, S302131, S302141, S302151INI · Traditional | 07/13/2018SE |
Questions and answers
When was Electric Wheelchair (Model: S7110) cleared by the FDA?
Electric Wheelchair (Model: S7110) (K200978) received a 510(k) decision of Substantially Equivalent on April 16, 2021, 368 days after the submission was received.
What is the product code of K200978?
The FDA product code is ITI – Wheelchair, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.3860.