Scout Boss
FDA 510(k) K023961 · Burke, Inc.
510(k) numberK023961
Submission
- Device name
- Scout Boss
- Applicant
- Burke, Inc.
Kansas City, KS, US - Received
- November 29, 2002
- Decision date
- December 24, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| K260335 | Electric Wheelchair (S500-6)ITI · Traditional | Zhongshan Sulenz Intelligent Technology Co., Ltd. | 06/15/2026SE |
| K261175 | WHILL (WHILL Model C2)ITI · Traditional | Whill, Inc. | 06/12/2026SE |
More from Whill, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K061912 | FusionINI · Traditional | 08/01/2006SE |
| K982158 | ScoutITI · Traditional | 08/31/1998SE |
| K965123 | Pace Saver, Little Junior (Modification)(Motorized Three-Wheeled Vehicle)INI · Traditional | 07/17/1997SE |
| K911943 | Concept Model 5200 Thermal Therapy SystemILO · Traditional | 07/19/1991SE |
| K893706 | Cold/Hot Fluid Radiation Pad NeutechILO · Traditional | 06/22/1989SE |
| K834506 | Pacesaver & ScoutINI · Traditional | 01/30/1984SE |
Questions and answers
When was Scout Boss cleared by the FDA?
Scout Boss (K023961) received a 510(k) decision of Substantially Equivalent on December 24, 2002, 25 days after the submission was received.
What is the product code of K023961?
The FDA product code is ITI – Wheelchair, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.3860.