OSSEOLITE is a Canadian innovation manufactured in North America according to medical quality controls for worldwide sales.
Osseolite devices are tested, and certified for your safety;
ISO 13485:2016 medical equipment quality control certified.
IEC 60601-2 (3rd) EMC/EMI approved.
CSA, NRTL approved, CMDCAS Health Canada licensed.
Cleared by FDA 510k process as a Class-II Medical equipment for Physical Medicine.
Designed and manufactured in Canada.
