PRODUCT REFERENCE
AirPhysio Regulatory and Quality Credentials
Quality and regulatory reference.
Regulatory
AirPhysio is TGA-listed (Australia) and US FDA 510(k)-cleared (K203209); the manufacturer holds ISO 9001 and ISO 13485 quality certification (verify current validity).
Quality Systems
Manufacturer holds ISO 9001 (quality management) and ISO 13485:2016 (medical devices) certification (verify current validity).
South African Distribution
Distributed under Health Brands SA's SAHPRA medical-device licence.
[REVIEW NEEDED BY: regulatory affairs - confirm SAHPRA licence reference and advertising-claim compliance]
Next step Full product documentation and references on request. Health Brands SA - airphysio.co.za.
Get AirPhysio® — R945 incl. 15% VAT
Drug-free airway clearance. Fulfilled by the official SA store.
This platform records measurements taken by your health practitioner and readings you self-report. It does not diagnose or treat any condition. AirPhysio® is a trademark of its manufacturer; claims are limited to airway clearance and lung-expansion support. Items requiring specialist confirmation are marked for review before external use.