510(k) Premarket Notification

• Device Classification Name: pad, heating, powered
• 510(K) Number: K111273
• Model: EH-6601, 6603, 6604 THRU 6614
• Device Name: FIR HEAT THERAPHY SYSYEMS
• Applicant: SHENZHEN ANPAN TECHNOLOGY CO., LTD.; #44, 2nd road, xiakeng, tongle; community, long gang town; shenzhen,
• Contact: wang tao
• Regulation Number: 890.5740
• Classification Product Code: IRT
• Subsequent Product Code: ILY
• Date Received: 05/04/2011
• Decision Date: 11/08/2011
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Physical Medicine
• Review Advisory Committee: Neurology
• summary: summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No