JWX-1 Plus (Navigo 16/Navigo 24)
FDA 510(k) K203806 · Yamaha Motor Co., Ltd.
510(k) numberK203806
Submission
- Device name
- JWX-1 Plus (Navigo 16/Navigo 24)
- Applicant
- Yamaha Motor Co., Ltd.
Iwata, JP - Received
- December 28, 2020
- Decision date
- May 21, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ITI – Wheelchair, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.3860
- Specialty
- Physical Medicine
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…
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Questions and answers
When was JWX-1 Plus (Navigo 16/Navigo 24) cleared by the FDA?
JWX-1 Plus (Navigo 16/Navigo 24) (K203806) received a 510(k) decision of Substantially Equivalent on May 21, 2021, 144 days after the submission was received.
What is the product code of K203806?
The FDA product code is ITI – Wheelchair, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.3860.