510(k) Premarket Notification

• Device Classification Name: stimulator, nerve, transcutaneous, over-the-counter
• 510(K) Number: K122744
• Models: PL009, PL009A, PL029
• Device Name: PROSPERA OTC TENS ELECTRONIC PULSE MASSAGER
• Applicant: PROSPERA CORPORATION; 5776 stoneridge mall rd; suite 288; pleasanton, CA 94588
• Contact: leon e jew
• Regulation Number: 882.5890
• Classification Product Code: NUH
• Subsequent Product Code: NGX
• Date Received: 09/07/2012
• Decision Date: 03/28/2013
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Neurology
• Review Advisory Committee: Neurology
• summary: summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No