ITI — Wheelchair, Powered Class II
FDA product code ITI covers "Wheelchair, Powered", a Class II medical device regulated under 21 CFR 890.3860. Submissions are reviewed by the Physical Medicine panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- ITI
- Device Class
- Class II
- Regulation Number
- 890.3860
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Definition
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 of device is not intended to climb stairs (see product code: IMK).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261149 | zhejiang lumbre electric appliance co | Electric Wheelchair (DY611A-2, DY612A-1) | July 10, 2026 |
| K261396 | ningbo resshidi medical devices co | Electric Wheelchair | July 8, 2026 |
| K261164 | yongkang ruihe metal product co | Electric wheelchair (XW-LY007 ) | July 7, 2026 |
| K260937 | shanghai waylong intelligent technology co | Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK) | June 24, 2026 |
| K253812 | zhejiang innuovo rehabilitation devices co | Power Wheelchair (W5915B, W5915C, W5915D) | June 18, 2026 |
| K260335 | zhongshan sulenz intelligent technology co | Electric Wheelchair (S500-6) | June 15, 2026 |
| K261175 | whill | WHILL (WHILL Model C2) | June 12, 2026 |
| K260056 | zhejiang innuovo rehabilitation devices co | Power Wheelchair (N5515A, N5516, N5517A, N5519) | June 5, 2026 |
| K260373 | jiangsu yveelt medical equipment co | Electric Wheelchair (DF506) | June 3, 2026 |
| K253241 | jiangsu intco medical products co | Electric Wheelchair (Y207BL) | May 13, 2026 |
| K253806 | zhejiang innuovo rehabilitation devices co | Power Wheelchair (N5919 series) | April 20, 2026 |
| K253952 | beijing orionstar technology co | Power Wheelchair (OS-R-M01S) | April 7, 2026 |
| K253340 | zhongshan a and j medical equipment co | Electric Wheelchair (AL-208S-063) | April 3, 2026 |
| K253980 | yurob rehabilitation medical co | Electrically Powered Wheelchair (Model YC-01) | March 27, 2026 |
| K254206 | ningbo zhishan medical technology co | Power wheelchair (ZS-EW8026) | March 27, 2026 |
| K253307 | foshan dahao medical technology co | Electric wheelchair | March 27, 2026 |
| K254012 | nanjing caremoving rehabilitation equipment co | Electric Wheelchair (E201) | March 24, 2026 |
| K253849 | zhejiang j and j mobility co | Electric wheelchair (JJW-7002, JJW-7003) | March 20, 2026 |
| K252101 | yamaha motor co | JWG-1 | March 19, 2026 |
| K253870 | suzhou master machinery manufacturing co | Electric Wheelchair (MP148) | March 4, 2026 |