Identifiers
- 510(k) Number
- K130864 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 C-Max Plus is a powered patient transport device designed for physical medicine applications. It functions as a stair climbing system to assist in the movement of patients.
This device is regulated as a Class 2 medical device and has received FDA 510(k) clearance. It is manufactured by Aat Alber Antriebstechnik GmbH and is subject to the requirements associated with product code ILK.
Frequently asked questions
What is the primary function of the C-Max Plus?
The C-Max Plus is a powered patient transport device engineered specifically for physical medicine applications. It functions as a stair climbing system to assist caregivers in the movement of patients, facilitating mobility in environments where stairs are present.
What is the regulatory classification of this device?
The C-Max Plus is regulated as a Class 2 medical device. It has received FDA 510(k) clearance under the product code ILK, which pertains to powered patient transport systems used within the field of physical medicine.
Who is the manufacturer of the C-Max Plus?
The device is manufactured by Aat Alber Antriebstechnik GmbH. The company manages the production and regulatory compliance of the system, which is documented under the FDA 510(k) clearance number K130864.
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: K130864 FDA 510 (k) - C-MAX+ (PLUS), AAT C-MAX USER MANUAL Pdf Download | ManualsLib, AAT c-max+ Original Bedienungsanleitung - ManualsLib
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K130864 | Class II | Active |
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Manufacturer
- Manufacturer
- Aat Alber Antriebstechnik GmbH
Sources (1)
- FDA 510(k) K130864 24 fields · synced Sep 22, 2026