Powered Wheelchair
FDA 510(k) K962565 · Orthofab, Inc.
510(k) numberK962565
Submission
- Device name
- Powered Wheelchair
- Applicant
- Orthofab, Inc.
Quebec, Quebec, CA - Received
- July 1, 1996
- Decision date
- March 20, 1997
- 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…
Other 510(k)s with product code ITI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260229 | Electric wheelchair (HC819N, HC830N, HC831N)ITI · Traditional | Yongkang Hengyi Vehicle Co., Ltd. | 09/08/2026SE |
| K260053 | Power Wheelchair (OS-R-M01I)ITI · Traditional | Beijing OrionStar Technology Co., Ltd. | 09/08/2026SE |
| K261354 | Electric wheelchair (D03)ITI · Traditional | Foshan Sowell Medical Technology Co., Ltd. | 08/21/2026SE |
| K261149 | Electric Wheelchair (DY611A-2, DY612A-1)ITI · Traditional | Zhejiang Lumbre Electric Appliance Co., Ltd. | 07/10/2026SE |
| K261396 | Electric WheelchairITI · Traditional | Ningbo Resshidi Medical Devices Co., Ltd. | 07/08/2026SE |
| K261164 | Electric wheelchair (XW-LY007 )ITI · Traditional | Yongkang Ruihe Metal Product Co., Ltd. | 07/07/2026SE |
| K260937 | Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK)ITI · Traditional | Shanghai Waylong Intelligent Technology Co.,Ltd | 06/24/2026SE |
| K253812 | Power Wheelchair (W5915B, W5915C, W5915D)ITI · Traditional | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 06/18/2026SE |
| 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 |
|---|---|---|
| K952675 | Orthofab WheelchairITI · Traditional | 05/07/1996SE |
| K950904 | Orthofab Wheelchair Astra (Folding Manual Wheelchair)IOR · Traditional | 04/05/1995SE |
| K950903 | Orthofab Wheelchair Ultima (Rigid Frame Manual Wheelchair)IOR · Traditional | 04/05/1995SE |
| K884812 | Karma-Rs, Karma-Fs WheelchairsITI · Traditional | 12/27/1988SE |
| K860095 | Digikit Nonpneumatic TourniquetKCY · Traditional | 01/24/1986SE |
| K852661 | Apollo Sterile BladesGES · Traditional | 07/11/1985SE |
Questions and answers
When was Powered Wheelchair cleared by the FDA?
Powered Wheelchair (K962565) received a 510(k) decision of Substantially Equivalent on March 20, 1997, 262 days after the submission was received.
What is the product code of K962565?
The FDA product code is ITI – Wheelchair, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.3860.