Certifications
Pelstar LLC, maker of Health o meter® Professional scales, is a certified ISO 13485:2016 and ISO 9001:2015 company. These certifications mean 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. ISO 9001:2015 are the standards used to manage our quality management system ensuring the company consistently provides products and services that meet customer and regulatory requirements and demonstrates continuous improvement.
Download ISO 13485:2016 Certificate Download ISO 9001:2015 Certificate
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.
weigheasier®
Refer to a scale’s product page to learn about specific certifications.
CSA
Products bearing this symbol meet the public safety and quality standards set by the Canadian Standards Association.
cMetus
The MET Mark indicates that the product has been evaluated for safety by an approved independent lab in accordance with the national standard and in compliance by virtue of MET’s equivalent accreditations to UL and CSA.
cMet
The MET Mark indicates that the product has been evaluated for safety by an approved independent lab in accordance with the national standard and in compliance by virtue of MET’s equivalent accreditations to the Canadian Standards Association.
CE
Certifies that the product bearing this symbol has passed the appropriate European quality assurance tests conducted by a qualified third party. CE stands for fulfillment of the European Directive 93/42 EEC for medical devices and declares the conformity.
NTEP
Scales bearing this symbol are certified as Legal for Trade by the National Conference on Weights and Measures.
TAA Compliant
Manufacturing of this scale meets the rules and requirements of the Trade Agreements Act.