Certificate of Compliance Certificate Number: Zynex-60601-04-COC Date Issued: October 5, 2011 Issued to: Zynex Medical, inc. ‘9990 Park Meadows Drive Lone Tree Colorado 80124, USA. Attention: Mr. Alex Russo PRODUCTS ‘Transcutaneous Electrical Nerve Stimulator, model NexWave, portable handheld type, internally powered (9Vde non-rechargeable type alkaline battery) or externally powered (Class I! medical grade power supply with output rated 12Vde 1.25) with Type BF Patient Appied Parts. APPLIGABLE REQUIREMENTS General Requirements: BS EN60601-1:2008 —_- Medical Electrical Equipment - Part 1: General Requirements For Basic Safety and Essential Performance BS EN60601-2-10: 2001 - Safety of Nerve and Muscle Stimulators (COMPLIANCE TO EU HARMONIZED STANDARDS & DIRECTIVE(S) ‘A sample of the subject product was evaluated, tested to, and found to be in compliance with the above Standards. The Manufacturer is therefore eligible to include the subject Standards in their Declaration of Conformity for CE Marking the subject product, subject to continuing compliance to all the provisions of the Medical Device Directive 93/42/EEC (as amended by 2007/47IEC). CONDITIONS OF ACCEPTABILITY “The equipment is provided with a User's Manual for its’ safe use in a national language that is acceptable to the authorities in the country where the equipment is to be used, Reference Test Repart No: Zynex-60601 -04, dated October 5, 2011 Xa, ax John tty Technical Manager Compliance Integrity Services 1822 Skyway Drive, Unit J Longmont Colorado 80504, USA