Primary Certifications:
IEC 60601-1-1
IEC 60601-1-2
P200
Regulatory class: Class I
Regulation #: 21 CFR 890.5380
Regulation name: Powered exercise equipment
Product code: BXB
M300:
Regulatory class: Class I, exempt
Regulation #: 21 CFR 890.5380
Regulation name: Powered exercise equipment
Product code: BXB
GTrainer 510(k) : K072887
The M300 was found exempt from premarket notification based on our submission.
