Identifiers
- 510(k) Number
- K982066 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)
A powered wheelchair designed for individuals with limited ambulation ability and insufficient upper-body strength to propel a manual wheelchair. The device provides motorised propulsion to assist users in mobility, enhancing independence for those with physical impairments.
The MP-3 Power Base Chair is intended for clinical use in physical medicine settings and has received FDA 510(k) clearance under the Traditional pathway. It is classified as a Class II device and is supplied as a reusable medical product. No specific sterility or MRI safety information is provided in the regulatory data.
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: K982066 FDA 510 (k) - MP-3 POWER BASE CHAIR, MP-3 POWER BASE CHAIR (K982066) — FDA 510(k) | Innolitics, Merits Health Products., Inc. FDA 510(k) Products (1993-2001), Mp-3 Power Base Chair 510 (k) FDA Premarket Notification K982066 MERITS ..., Electric wheelchair - P310 (MP-3C) - Merits Health Products - outdoor ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K982066 | Class II | Active |
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Manufacturer
- Manufacturer
- Merits Health Products., Inc.
Sources (1)
- FDA 510(k) K982066 24 fields · synced Sep 19, 2026