Regulartory and Reimbursement

Anodyne^® Therapy
The Trusted Name in Light Therapy

13570 Wright Circle
Tampa, FL 33626
800-521-6664

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Regulatory & Reimbursement
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Regulatory Documents

U.S. Food and Drug Administration

• FDA Clearance Letter Explanation
• FDA 510(k) Clearance
• Letter from FDA - Name Change
• Letter from FDA - Correction of Classification

Certificates

• ISO 13485 Certificate of Registration
• OSHA Safety Certification to UL/CSA 60601-1 (480)
• OSHA Safety Certification to UL/CSA 60601-1 (120)
• CE Certificate

Product Documentation

• Trademark, Patent Info and Product Warranty

U.S. Reimbursement

• Medicare NCD Clarification
• Billing Codes for Part B
• ICD-9 Coding
• When Reimbursement is Denied

Anodyne® Therapy is an FDA-Cleared medical device for temporarily increasing circulation and
reducing pain, stiffness and muscle spasm.
Anodyne® Therapy and MIRE™ are registered trademarks of Anodyne Therapy, LLC.
Anodyne Therapy is patented in the United States, Canada and Europe.