Product Certifications

Primary Certifications:
 IEC 60601-1-1
 IEC 60601-1-2
 IEC 60601-1-3
 ISO-13485: 2012

M320:
 Regulatory class: Class I, exempt
 Regulation #: 21 CFR 890.5380
 Regulation name: Powered exercise equipment
 Product code: BXB

Bionic Leg:
 Regulatory class: Class I, exempt
 Regulation #: 21 CFR 890.5380
 Regulation name: Powered exercise equipment
 Product code: BXB