Identifiers
- 510(k) Number
- K012927 FDA 510(k)
- FDA Product Code
- ITI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.3860 FDA 510(k)
- Regulation Number
- 890.3860 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The M71 Power Wheelchair is a rigid, non-folding, mid-wheel drive power wheelchair designed for mobility assistance. It features a steel tube frame, front-wheel walking beam suspension for obstacle negotiation, and rear anti-tipper casters. The device is powered by two 12V deep-cycle gel cell batteries.
It is supplied as a reusable device intended for use in mobility assistance settings. The device has received FDA 510(k) clearance under K012927 and is classified as a Class II medical device with product code ITI and regulation number 890.3860. It is manufactured by Invacare Corp. and authorized for distribution in the United States.
Frequently asked questions
What is the M71 Power Wheelchair used for?
The M71 Power Wheelchair is designed for mobility assistance, providing powered movement for individuals who require support with ambulation due to disability or injury.
Is the M71 Power Wheelchair reusable or single-use?
The M71 Power Wheelchair is supplied as a reusable device, intended for repeated use in mobility assistance settings rather than single-patient, single-use disposal.
What type of drive system does the M71 Power Wheelchair have?
The M71 Power Wheelchair features a mid-wheel drive system, which positions the drive wheels beneath the user's center of gravity for improved maneuverability and tight turning capability.
What power source does the M71 Power Wheelchair use?
The M71 Power Wheelchair is powered by two 12V deep-cycle gel cell batteries, which provide sustained energy for extended mobility use and are designed for repeated charging cycles.
What suspension and stability features does the M71 Power Wheelchair include?
The M71 Power Wheelchair includes front-wheel walking beam suspension to help negotiate obstacles and rear anti-tipper casters to enhance stability and prevent backward tipping during use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Invacare Pronto M71 Owner's Operator And Maintenance Manual, Invacare M71 Owner's Operator And Maintenance Manual, Invacare Pronto M71 : Power Wheelchair Owner's Operator ... - ManualShelf, M71 POWER WHEELCHAIR (K012927) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K012927 | Class II | Active |
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Manufacturer
- Manufacturer
- Invacare Corp.
Sources (1)
- FDA 510(k) K012927 24 fields · synced Sep 24, 2026