Powered Wheelchair DYW30A(D09)
FDA 510(k) K170787 · Nanjing Jin Bai HE Medical Apparatus Co., Ltd.
510(k) numberK170787
Submission
- Device name
- Powered Wheelchair DYW30A(D09)
- Applicant
- Nanjing Jin Bai HE Medical Apparatus Co., Ltd.
Nanjing, CN - Received
- March 16, 2017
- Decision date
- August 9, 2017
- 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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| K201196 | Scooter (Model: FDB01)INI · Traditional | 06/25/2021SE |
Questions and answers
When was Powered Wheelchair DYW30A(D09) cleared by the FDA?
Powered Wheelchair DYW30A(D09) (K170787) received a 510(k) decision of Substantially Equivalent on August 9, 2017, 146 days after the submission was received.
What is the product code of K170787?
The FDA product code is ITI – Wheelchair, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.3860.