HP358EA Electrically Powered Wheelchair
FDA 510(k) K211647 · Kunshan Hi-Fortune Health Products Co., Ltd.
510(k) numberK211647
Submission
- Device name
- HP358EA Electrically Powered Wheelchair
- Applicant
- Kunshan Hi-Fortune Health Products Co., Ltd.
Kunshan, CN - Received
- May 28, 2021
- Decision date
- January 4, 2022
- 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…
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More from Whill, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K244003 | Electrically powered wheelchairITI · Traditional | 03/26/2025SE |
| K243962 | Electrically Powered WheelchairITI · Special | 02/12/2025SE |
| K243961 | Electrically Powered WheelchairITI · Special | 02/12/2025SE |
| K241337 | Electrically powered wheelchair (HP202)ITI · Traditional | 10/17/2024SE |
| K241632 | Electrically powered wheelchairITI · Traditional | 10/16/2024SE |
| K212503 | HP458E Electrically Powered WheelchairITI · Traditional | 01/18/2022SE |
| K201855 | Electrically Powered Wheelchair -Model HP358EITI · Traditional | 09/28/2021SE |
| K163352 | WheelchairIOR · Traditional | 07/28/2017SE |
Questions and answers
When was HP358EA Electrically Powered Wheelchair cleared by the FDA?
HP358EA Electrically Powered Wheelchair (K211647) received a 510(k) decision of Substantially Equivalent on January 4, 2022, 221 days after the submission was received.
What is the product code of K211647?
The FDA product code is ITI – Wheelchair, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.3860.