INSIGHT

Stimulator, Nerve, Transcutaneous, For Pain Relief

STAODYNAMICS, INC.

The following data is part of a premarket notification filed by Staodynamics, Inc. with the FDA for Insight.

Pre-market Notification Details

• Device ID: K811345
• 510k Number: K811345
• Device Name: INSIGHT
• Classification: Stimulator, Nerve, Transcutaneous, For Pain Relief
• Applicant: STAODYNAMICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: GZJ
• CFR Regulation Number: 882.5890 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1981-05-12
• Decision Date: 1981-07-10