Penox Performer Wheelchair
FDA 510(k) K852109 · Penox Technologies, Inc.
510(k) numberK852109
Submission
- Device name
- Penox Performer Wheelchair
- Applicant
- Penox Technologies, Inc.
Pittston, PA, US - Received
- May 15, 1985
- Decision date
- August 22, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IOR – Wheelchair, Mechanical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3850
- Specialty
- Physical Medicine
A mechanical wheelchair is a manually 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/or require an assistive device for mobility.
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| K252370 | GEN 4 JOY WheelchairIOR · Traditional | Free Wheelchair Mission | 07/24/2026SE |
| K261076 | Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02)IOR · Traditional | GuangDong Yong Yi Rehabilitation Equipment… | 06/22/2026SE |
| K261075 | Manual Wheelchair (MS01);Manual Wheelchair (MA01)IOR · Traditional | GuangDong Yong Yi Rehabilitation Equipment… | 06/22/2026SE |
| K260849 | Icon 35; Icon 45; Icon 60; Icon 30FAFIOR · Traditional | Rehasense USA, Inc. | 06/11/2026SE |
| K260642 | Manual Wheelchair (LW01108)IOR · Traditional | Anhui Longway Medical Technology Co., Ltd. | 06/02/2026SE |
| K260295 | Helio Kids; Apex PIOR · Traditional | Motion Composites | 05/28/2026SE |
| K254141 | Manual Wheelchair (DY01903(2))IOR · Traditional | Guangdong Dayang Medical Technology Co., Ltd. | 05/21/2026SE |
| K260121 | Manual Wheelchair (7101L, 7102LHD)IOR · Traditional | Foshan Nanhai Hongchen Medical Equipment Co., Ltd. | 04/28/2026SE |
| K260319 | K5 wheelchair (16 with swing-away footrest 18 with swing-away footrest 20 with…IOR · Traditional | Zhenjiang Assure Medical Equipment Co., Ltd. | 03/31/2026SE |
More from Zhenjiang Assure Medical Equipment Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K864667 | Penox Hospital BedFNJ · Traditional | 01/21/1987SE |
| K863978 | Portable Liquid Oxygen Unit (Modification)BYJ · Traditional | 12/15/1986SE |
| K862654 | Modified Penox Lift ChairINO · Traditional | 07/18/1986SE |
| K853775 | Penox High Flow ManifoldBYJ · Traditional | 11/29/1985SE |
| K851218 | Penox Lift ChairINO · Traditional | 06/21/1985SE |
| K851219 | Fill Hose Safety AdapterCAM · Traditional | 06/18/1985SE |
| K851217 | Penox Dual Flow MinifoldCAM · Traditional | 06/18/1985SE |
| K851216 | Penox Dual Feed ManifoldCAM · Traditional | 06/18/1985SE |
| K851215 | T-Handle Adapter, U-Handle & L Handler AdapterCAM · Traditional | 06/18/1985SE |
Questions and answers
When was Penox Performer Wheelchair cleared by the FDA?
Penox Performer Wheelchair (K852109) received a 510(k) decision of Substantially Equivalent on August 22, 1985, 99 days after the submission was received.
What is the product code of K852109?
The FDA product code is IOR – Wheelchair, Mechanical, a Class I (low risk) device regulated under 21 CFR 890.3850.