Ki Power Tilt System
FDA 510(k) K201869 · Ki Mobility, LLC
510(k) numberK201869
Submission
- Device name
- Ki Power Tilt System
- Applicant
- Ki Mobility, LLC
Stevens Point, WI, US - Received
- July 7, 2020
- Decision date
- September 5, 2023
- 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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| K261175 | WHILL (WHILL Model C2)ITI · Traditional | Whill, Inc. | 06/12/2026SE |
More from Whill, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K200583 | Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTLIOR · Traditional | 09/05/2023SE |
| K223533 | Little Wave Arc; Little Wave FlipLBE · Traditional | 08/31/2023SE |
| K223527 | Little Wave Clik, Rogue XP, Little Wave XP, SparkIOR · Traditional | 08/31/2023SE |
| K062660 | CatalysyIOR · Traditional | 10/24/2006SE |
Questions and answers
When was Ki Power Tilt System cleared by the FDA?
Ki Power Tilt System (K201869) received a 510(k) decision of Substantially Equivalent on September 5, 2023, 1,155 days after the submission was received.
What is the product code of K201869?
The FDA product code is ITI – Wheelchair, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.3860.