Bruno Electra-Ride III Stairway Elevator System, Model CRE-2100
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K033829 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 Bruno Electra-Ride III Stairway Elevator System, Model CRE-2100, is a powered patient transport device. It is designed to assist individuals with mobility limitations by providing a mechanical means of navigating stairways.
This device is a battery-powered stairway elevator that has received FDA 510(k) clearance. It is intended for installation by authorized dealers to ensure proper setup and maintenance. The system is classified as a class 2 medical device under regulation number 890.5150.
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: BRUNO ELECTRA-RIDE III INSTALLATION MANUAL Pdf Download, Bruno ELECTRA-RIDE III CRE-2100 Operator's Manual | Manualzz, Bruno - Electra Ride III - Cre 2100 - Install Manual - 03 08 ... - Scribd, Bruno Electra-Ride CRE-2100 Stairway Elevator Operator's Manual
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K033829 | Class II | Active |
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Manufacturer
- Manufacturer
- Bruno Independent Living Aids, Inc.
Sources (1)
- FDA 510(k) K033829 24 fields · synced Sep 21, 2026