Merits E600 Series Stair Lift
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K073110 FDA 510(k)
- FDA Product Code
- ILK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5150 FDA 510(k)
- Regulation Number
- 890.5150 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Merits E600 Series Stair Lift is a Powered Patient Transport Device designed to assist in the vertical movement of patients or mobility-impaired individuals between floors via staircases. It falls under the classification of a motorized stairway chairlift, providing safe and controlled transfers where ramps or elevators are impractical.
This device is intended for use in clinical, home, or institutional settings and is supplied as a reusable, non-sterile medical transport solution. It operates within the constraints of FDA 510(k) clearance (K073110, Product Code ILK) and is classified as a Class II device under the Physical Medicine specialty. Storage and maintenance instructions are provided by the manufacturer to ensure proper functionality and safety.
Frequently asked questions
What types of environments is the Merits E600 Series Stair Lift intended for use in?
The Merits E600 Series Stair Lift is designed for use in clinical settings like hospitals, as well as home or institutional environments where staircases are present and ramps or elevators are not feasible. Its purpose is to safely transport patients or mobility-impaired individuals vertically between floors.
Is the Merits E600 Series Stair Lift reusable or single-use, and what does that mean for maintenance?
The Merits E600 Series Stair Lift is a reusable device, meaning it is not intended for one-time use. This design allows for repeated use in different settings, but it requires proper cleaning, maintenance, and storage as outlined by the manufacturer to ensure safety and functionality over time.
How is the Merits E600 Series Stair Lift classified under FDA regulations, and what does that imply for its use?
The device is classified as a Class II medical device under the FDA’s Physical Medicine specialty, with a 510(k) clearance (K073110). This classification means it has undergone regulatory review to ensure safety and effectiveness for its intended purpose—assisting in the vertical transport of patients or mobility-impaired individuals—while adhering to established standards for motorized stairway chairlifts.
What does the non-sterile designation mean for the Merits E600 Series Stair Lift, and how should it be handled?
The Merits E600 Series Stair Lift is non-sterile, meaning it is not intended for use in sterile procedures or environments where infection control requires sterile equipment. However, it should still be cleaned and maintained according to the manufacturer’s guidelines to prevent contamination and ensure safe, hygienic use for patient transport.
What should I consider when storing the Merits E600 Series Stair Lift to ensure its longevity and functionality?
The manufacturer provides specific storage and maintenance instructions to preserve the device’s functionality and safety. While exact details aren’t provided here, typical considerations for a reusable stair lift include keeping it in a dry, protected environment away from extreme temperatures, ensuring components are properly secured, and following any lubrication or inspection protocols outlined in the user manual.
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 E600 SERIES STAIR LIFT (K073110) — FDA 510 (k) | Innolitics, Stair Lifts - Merits Health Products, Merits E600 Series Stair Lift - Beudamed, Merits E600 Series Stair Lift 510 (k) FDA Premarket Notification ..., PDF K073110 - MERITS E600 SERIES STAIR LIFT - 510kdatabase.net
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K073110 | Class II | Active |
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Manufacturer
- Manufacturer
- Merits Health Products Co., Ltd.
Sources (1)
- FDA 510(k) K073110 24 fields · synced Sep 19, 2026