General Statement
Outlines regulatory status of WAKELIFE products and responsibilities of buyers/OEM/ODM partners. For informational purposes only.
Product Classification
Red light therapy devices are generally for wellness, cosmetic, or professional use. Medical device classification depends on local law, intended use, labeling, and marketing claims.
Regional Regulatory Differences
Requirements vary:
- NOUS: FDA
- UE: MDR
- ROYAUME-UNI: UK MDR
WAKELIFE does not guarantee compliance in all jurisdictions.
Buyer/OEM/ODM Responsibilities
- Determine classification
- Obtain registrations/approvals
- Ensure labeling and marketing compliance
- Conduct post-market surveillance
Certifications and Standards
May comply with CE, FCC, Rohs, ISO as applicable. Confirm per product.
No Guarantee of Regulatory Approval
Compliance with standards does not guarantee approval. Depends on intended use and local authority decisions.
Updates to Regulations
Buyers must stay informed of regulations in target markets.