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Merits Wheelchair

FDA 510(k)

Class II (US FDA 510(k))

510(k) K933662

by Merits Health Products., Inc.

Identifiers

510(k) Number
K933662 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
SN FDA 510(k)

This device is a powered wheelchair. It is classified as a Class II medical device under the FDA product code ITI and regulation number 890.3860.

The device received traditional 510(k) clearance (K933662) on March 30, 1994, following submission on July 27, 1993. It is manufactured by Merits Health Products, Inc. and is intended for use in physical medicine settings.

Frequently asked questions

What is the Merits Wheelchair intended for?

The Merits Wheelchair is intended for use in physical medicine settings, as stated in its device description and supported by its classification under FDA product code ITI and regulation number 890.3860, which pertains to powered wheelchairs used in rehabilitation and mobility assistance.

How was the Merits Wheelchair cleared for market release?

The Merits Wheelchair received traditional 510(k) clearance from the FDA under submission K933662, which was submitted on July 27, 1993, and cleared on March 30, 1994, based on a determination of substantial equivalence for some indications.

What regulatory classification does the Merits Wheelchair hold?

The Merits Wheelchair is classified as a Class II medical device by the FDA, as indicated in the device data under the product code ITI and regulation number 890.3860, which governs powered wheelchairs used in physical medicine applications.

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: Merits Health Products | Enhancing Life Through Mobility, Merits Health Products | Enhancing Life Through Mobility, Power Wheelchairs - Merits Health Products, Leader In Mobility Solutions - Merits Health Products, Merits Mobility Scooters and Electric Wheelchairs

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Merits Health Products., Inc.

Sources (1)

  • FDA 510(k) K933662 24 fields · synced Oct 1, 2026