Pelstar LLC, maker of Health o meter® Professional scales, is a certified ISO 13485:2016 company. This certification means that we manage our company at the standards of the International Organization for Standardization (ISO). ISO 13485:2016 sets forth requirements for the management system of design and manufacture of medical devices such as meeting regulatory and customer requirements while also managing risk and efficiency.
Some of our products have been tested for additional certifications such as CSA/cMet, CE and Class III. Refer to a product’s Features and Benefits sheet to learn about specific certifications.
All of our products are registered with the US Food and Drug Administration as Class I medical devices.
Refer to a scale’s product page to learn about specific certifications.