Compliance Statement
OXYSPRINT®: STATEMENT OF PRODUCT CLASSIFICATION & COMPLIANCE
Product: OXYSPRINT® Portable Oxygen Canister (1000mL)
Trademark Registration Number: 229382
Classification: Recreational Wellness Supplement / Fitness Accessory
1. Product Intent & Usage
OXYSPRINT® is designed exclusively for recreational use by healthy individuals. The product is marketed as a lifestyle and performance accessory intended to assist with:
Athletic Recovery: Aiding revitalisation after high-intensity physical exertion.
Altitude Adjustment: Providing supplemental freshness for hikers and travellers in high-elevation environments.
General Wellness: Refreshing the user in poorly ventilated or high-density urban environments.
2. Regulatory Compliance & Non-Medical Status
OXYSPRINT® does not fall under the category of a "Medical Device" or "Prescription Drug" as defined by standard international commerce guidelines for the following reasons:
No Medical Claims: The product is not marketed to diagnose, treat, cure, or prevent any physical or mental disease or condition.
Non-Clinical Design: It is not intended for use in hospitals, ambulances, or for individuals with chronic respiratory illnesses.
Supplement Classification: OXYSPRINT® is categorized as a wellness supplement, similar to electrolyte beverages, vitamins, or topical sports accessories.
3. Safety and Quality Standards
While classified as a lifestyle product, OXYSPRINT® adheres to rigorous manufacturing standards to ensure consumer safety:
· ISO 9001 UCC Certified: Quality Management System compliant.
· SIS Certified (SIS621225CE057): Compliant with essential health, safety, and environmental protection standards for consumer goods.
· Non-Invasive: The delivery system is a non-invasive, ergonomic mask intended for external use only.
4. Commerce Policy Alignment
OXYSPRINT® aligns with Lifestyle and Fitness Accessories categories. It is an over-the-counter consumer good that contains no restricted substances, requires no prescription, and is available for general retail purchase.