ITI — Wheelchair, Powered Class II
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 |
|---|---|---|---|
| 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 |
| K253307 | foshan dahao medical technology co | Electric wheelchair | March 27, 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 |
| 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 |
| K253789 | zhejiang yikang medical technology co | Electric wheelchair | February 25, 2026 |
| K253707 | shenzhen zhimahuaerkai technology co | Electric wheelchair (W1,W3) | February 24, 2026 |
| K253599 | ningbo shenyu medical equipment co | Electric Wheelchair (W-A807, W-A807L) | February 17, 2026 |
| K253276 | shanghai bangbang robotics co | Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E | January 15, 2026 |