JWG-1— 510(k) K252101
Substantially EquivalentYamaha Motor Co., Ltd.
FDA 510(k) clearance K252101 for JWG-1, Substantially Equivalent on 2026-03-19. Applicant: Yamaha Motor Co., Ltd.. Device class: 2.
Summary
Yamaha Motor's JWG-1 is filed under ITI, powered wheelchairs. The record gives only that short designation as the device name.
Class II, 21 CFR 890.3860. Physical Medicine is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Yamaha Motor filed from Iwata City, Japan. Review took 259 calendar days (July 3, 2025 to March 19, 2026).
Clearance details
- Applicant
- Yamaha Motor Co., Ltd.
- Product code
- Product code ITI
- Device class
- Class 2
- Regulation
- 21 CFR 890.3860
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Iwata City, JP
Recent devices under product code ITI
view allMore clearances from Yamaha Motor Co., Ltd.
view allAdverse events under product code ITI
product code ITI- Death
- 34
- Injury
- 778
- Malfunction
- 1,085
- Other
- 1
- Total
- 1,898
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.