HEARTWAY Electrically Powered Wheelchair P27
FDA 510(k) K142783 · Heartway Medical Products Co., Ltd.
510(k) numberK142783
Submission
- Device name
- HEARTWAY Electrically Powered Wheelchair P27
- Applicant
- Heartway Medical Products Co., Ltd.
Taichung City, TW - Received
- September 26, 2014
- Decision date
- June 12, 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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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 |
| K142731 | HEARTWAY Electrically Powered WheelchairsITI · Traditional | 02/27/2015SE |
| 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 Wheelchair P27 cleared by the FDA?
HEARTWAY Electrically Powered Wheelchair P27 (K142783) received a 510(k) decision of Substantially Equivalent on June 12, 2015, 259 days after the submission was received.
What is the product code of K142783?
The FDA product code is ITI – Wheelchair, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.3860.