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 |
|---|---|---|---|
| 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 |
| K251458 | foshan dahao medical technology co | Electric Wheelchair (DH01168) | January 15, 2026 |
| K251159 | zhenjiang assure medical equipment co | Power wheelchair | December 22, 2025 |
| K252862 | foshan dahao medical technology co | Electric Wheelchair (DH01126) | December 8, 2025 |
| K252494 | nanjing kangni smart technology co | Electrically powered wheelchair (KZ301B) | December 5, 2025 |
| K252829 | suzhou kd intelligent device co | Powered Wheelchair (PL001-9001) | November 12, 2025 |
| K250819 | rollz international | Electric Wheelchair (Rollz Motion Electric 2M) | November 7, 2025 |
| K252671 | hebei dansong medical technology co | Electric wheelchair (NSDS-01) | November 3, 2025 |
| K251565 | zhejiang topwe tools manufacturing co | Wheelchair (N817) | October 6, 2025 |
| K252428 | superpi robot co | Electric Wheelchair (Model P2) | September 18, 2025 |
| K251891 | shandong guyue healthcare appliance co | Electric Wheelchair (GY-E001) | September 9, 2025 |
| K250729 | vive health | Power Wheelchair (MOB1107) | July 2, 2025 |
| K251285 | zhejiang automwheel tech co | Electric Wheelchair (HG-630) | July 2, 2025 |
| K251606 | anhui jbh medical apparatus co | Power Wheelchair (D26) | June 25, 2025 |
| K251248 | jinhua qidian vehicle co | ELECTRIC WHEELCHAIR (QDWP-A01,QDWP-B02) | June 20, 2025 |
| K250475 | ningbo baichen medical devices co | Electric Wheelchair (BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3) | May 27, 2025 |