Strive

Stimulator, Nerve, Transcutaneous, For Pain Relief

DJO, LLC

The following data is part of a premarket notification filed by Djo, Llc with the FDA for Strive.

Pre-market Notification Details

• Device ID: K153704
• 510k Number: K153704
• Device Name: Strive
• Classification: Stimulator, Nerve, Transcutaneous, For Pain Relief
• Applicant: DJO, LLC 1430 DECISION ST. Vista, CA 92081
• Contact: Rand Daoud
• Correspondent: Rand Daoud; DJO, LLC 1430 DECISION ST. Vista, CA 92081
• Product Code: GZJ
• Subsequent Product Code: NUH
• Subsequent Product Code: NYN
• CFR Regulation Number: 882.5890 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-12-23
• Decision Date: 2016-06-03
• Summary: summary