Geronimo
FDA 510(k) K935750 · Redman, Inc.
510(k) numberK935750
Submission
- Device name
- Geronimo
- Applicant
- Redman, Inc.
Tucson, AZ, US - Received
- November 26, 1993
- Decision date
- February 3, 1995
- Decision
- Substantially Equivalent for Some Indications (SN)
- 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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| K261396 | Electric WheelchairITI · Traditional | Ningbo Resshidi Medical Devices Co., Ltd. | 07/08/2026SE |
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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 |
|---|---|---|
| K940920 | Road SavageITI · Traditional | 02/03/1995SN |
| K940919 | Chief SRIPL · Traditional | 02/03/1995SN |
| K940852 | Chief Standup WheelchairIPL · Traditional | 02/03/1995SN |
| K940851 | Red Pack Manlual Power Wheelchair Conversion KitITI · Traditional | 02/03/1995SN |
| K935751 | Geronimo PRITI · Traditional | 02/03/1995SN |
| K935749 | Road WarriorITI · Traditional | 01/13/1995SN |
| K870298 | Redman AccessoriesKNO · Traditional | 02/26/1987SE |
| K870299 | Redman Upholstery Series for WheelchairsKNN · Traditional | 02/10/1987SE |
| K870297 | Dakota Model 102C WheelchairITI · Traditional | 02/10/1987SE |
| K870296 | Mohave Model 102W WheelchairIOR · Traditional | 02/10/1987SE |
Questions and answers
When was Geronimo cleared by the FDA?
Geronimo (K935750) received a 510(k) decision of Substantially Equivalent for Some Indications on February 3, 1995, 434 days after the submission was received.
What is the product code of K935750?
The FDA product code is ITI – Wheelchair, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.3860.