Warranty14, Declaration of Conformity | Drive Medical Design 18605

warranty14

Manufacturer: Drive Medical Design & Manufacturing

99 Seaview Boulevard

Port Washington, NY 11050

Product Designation : Type/Model: 18605

We herewith declare that the above-mentioned product complies with the requirements of EC Directive 93/42/EEC and the following:

Class: IIa, Rule 2

Quality System Standards Applied: IS09001/ISO13485

Notified Body RWTUV

MDD Annex II Applied

Safety Standards Applied: EN60601-1/IEC 601-1:1988 including A1:1991 and A2:1995

CAN/CSA 22.2 No. 601.1-M90

UL 60601-1:2003

ISO 10079-1:1991

EMC (Electromagnetic Compatibility) Compliance to: EN 60601-1-2 (2001) [All applicable stan- dards available upon request]

EN55011 Class B

For Battery Operation Only: RTCA/DO-160D, Section 21 (Radiated Emissions), Category M. For Airline Use