Certifications

CERTIFICATIONS & STANDARDS

Manufactured in Canada since 2009 under an ISO 13485 certified quality management system, with materials tested to ISO 10993 biocompatibility standards.

[ ISO ]ISO 13485:2016

MEDICAL DEVICE QUALITY MANAGEMENT SYSTEM

Produced in Canada under an ISO 13485:2016 certified quality management system.

Scope: Canadian Manufacturing Facility

[ ISO ]ISO 9001:2015

PARTNER QUALITY MANAGEMENT

ISO 9001 quality management certification held by key manufacturing and materials partners supporting Modulus tape products.

Scope: Canadian Manufacturing Facility

[ CLASS I ]Medical Device

MEDICAL DEVICE CLASSIFICATION

Classified and registered as Class I medical devices under applicable Health Canada and U.S. FDA regulations.

Issuer: Health Canada
Scope: Canada

[ US HEALTH ]HSA / FSA

HEALTHCARE ACCOUNT ELIGIBILITY

May be eligible for purchase using Health Savings Account (HSA) or Flexible Spending Account (FSA) in the United States when sold as kinesiology tape.

Scope: United States

[ BIO ]ISO 10993-5

CYTOTOXICITY

Materials are tested to ISO 10993 standards, with no cytotoxic effects observed.

Issuer: Accredited Third-Party Lab

[ DERMAL ]ISO 10993-10

SENSITIZATION

Testing met ISO 10993 sensitization requirements, indicating low potential for sensitization response.

Issuer: Accredited Third-Party Lab

[ DERMAL ]ISO 10993-10

SKIN IRRITATION

Testing met ISO 10993 irritation requirements, supporting skin compatibility during application and wear.

Issuer: Accredited Third-Party Lab

[ RESEARCH ]Research & Clinical Insights

RESEARCH & CLINICAL INSIGHTS

Kinesiology tape has been extensively studied across a range of applications, with research exploring its role in movement, rehabilitation, and performance support.

[ FABRIC ]95 : 5 Cotton–Spandex

PREMIUM FIBER BLEND

A precise 95-part cotton, 5-part spandex construction engineered for elasticity, breathability, and prolonged skin contact in therapeutic applications.

[ ADHESIVE ]Medical-Grade Acrylic

SKIN-COMPATIBLE FORMULA

Medical-grade acrylic adhesive selected for skin compatibility, secure wear, and reduced irritation across the full duration of treatment, sourced from qualified suppliers.

[ ORIGIN ]Made in Canada

CANADIAN MANUFACTURING

Every Modulus tape product is manufactured in our ISO-certified Canadian facility, supporting direct oversight of quality, traceability, and regulatory compliance.