805 Power Chair Conversion System
FDA 510(k) K883671 · Rolcontrol Products, Co., Inc.
510(k) numberK883671
Submission
- Device name
- 805 Power Chair Conversion System
- Applicant
- Rolcontrol Products, Co., Inc.
Camarillo, CA, US - Received
- August 18, 1988
- Decision date
- September 13, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| 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 |
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| 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 |
|---|---|---|
| K885106 | Removable Battery Power SystemKNN · Traditional | 12/27/1988SE |
| K885105 | Sliding Arm SupportKNN · Traditional | 12/27/1988SE |
| K885104 | Laydown Arm Support MechanismKNN · Traditional | 12/27/1988SE |
| K885103 | 1600 Light Touch ControlITI · Traditional | 12/27/1988SE |
| K883679 | Wheels-Off Quick Release Axle SystemKNN · Traditional | 09/13/1988SE |
| K883678 | 4007 Model Recliner ControllerITI · Traditional | 09/13/1988SE |
| K883674 | Manual Swing ArmITI · Traditional | 09/13/1988SE |
| K883673 | Power Mechanical ReclinerITI · Traditional | 09/13/1988SE |
| K883672 | Paralyzed Veterans of America Power ReclinerITI · Traditional | 09/13/1988SE |
Questions and answers
When was 805 Power Chair Conversion System cleared by the FDA?
805 Power Chair Conversion System (K883671) received a 510(k) decision of Substantially Equivalent on September 13, 1988, 26 days after the submission was received.
What is the product code of K883671?
The FDA product code is ITI – Wheelchair, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.3860.