INI — Vehicle, Motorized 3-Wheeled Class II
FDA product code INI covers "Vehicle, Motorized 3-Wheeled", a Class II medical device regulated under 21 CFR 890.3800. 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
- INI
- Device Class
- Class II
- Regulation Number
- 890.3800
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261859 | anhui jbh medical apparatus co | Electric Scooter (FDB08, FDB08A, FDB12) | September 19, 2026 |
| K260176 | zhejiang innuovo rehabilitation devices co | Mobility Scooter (W3483, W3483A) | August 10, 2026 |
| K260094 | zhejiang innuovo rehabilitation devices co | Mobility Scooter (W3465, W3902 (S50 Carbon)) | August 10, 2026 |
| K261232 | jochu technology co | IERO Mobility Scooter (IERO-01) | July 14, 2026 |
| K261163 | yongkang ruihe metal product co | Mobility Scooter (R200) | July 7, 2026 |
| K253257 | jiangsu intco medical products co | Virgo Mobility Scooter (Virgo-D,Virgo-F) | June 8, 2026 |
| K253600 | yurob rehabilitation medical co | Scooter (YD-03) | June 3, 2026 |
| K260717 | suzhou sweetrich vehicle industry technology co | Mobility Scooter (Air Carbon) | May 20, 2026 |
| K260237 | wuyi aichi industry and trade co | Mobility Scooter (X-12, X-14, X-17) | April 22, 2026 |
| K252813 | lerado zhongshan peaceful cove business trading co | Electrical Scooter (SM4226) | March 17, 2026 |
| K253936 | nanjing mijo technology co | Power Mobility Scooter (MJMA01, MJMA02) | March 12, 2026 |
| K253631 | zhejiang wei ling new energy technology co | Mobility Scooter (CL-Q3, CL-Q4) | February 23, 2026 |
| K253643 | shenzhen zhimahuaerkai technology co | Mobility Scooter (S3) | February 18, 2026 |
| K252349 | dongguan smarfody mobility technology co | Electric Scooter (Mojo-T330) | January 29, 2026 |
| K252347 | dongguan smarfody mobility technology co | Electric Scooter (Mojo-T580) | January 29, 2026 |
| K252275 | zhejiang nysin medical co | Electric Scooter (DDF100) | January 29, 2026 |
| K253075 | suzhou sweetrich vehicle industry technology co | Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scoot | January 9, 2026 |
| K252817 | ningbo baichen medical devices co | Mobility Scooter (BC-MS310) | January 2, 2026 |
| K252835 | guangdong prestige technology co | Electric Scooter (S202572J, S2060, M2089, S2050) | December 23, 2025 |
| K252588 | zhejiang taotao vehicle co | Mobility Scooter (T5) | December 4, 2025 |