Folding Wheelchair
FDA 510(k) K915108 · Guardian Products Co., Inc.
510(k) numberK915108
Submission
- Device name
- Folding Wheelchair
- Applicant
- Guardian Products Co., Inc.
North Hollywood, CA, US - Received
- November 13, 1991
- Decision date
- January 13, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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| 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 |
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| K790299 | Forearm-CaneIPS · Traditional | 02/21/1979SE |
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Questions and answers
When was Folding Wheelchair cleared by the FDA?
Folding Wheelchair (K915108) received a 510(k) decision of Substantially Equivalent on January 13, 1992, 61 days after the submission was received.
What is the product code of K915108?
The FDA product code is IOR – Wheelchair, Mechanical, a Class I (low risk) device regulated under 21 CFR 890.3850.