LogoFDA 510(k) Search
K Number
K940954
Device Name
SYNAPTIC 3000
Manufacturer
THE SYNAPTIC CORP.
Date Cleared
1997-06-20

(1207 days)

Product Code
GZJ,84G
Regulation Number
882.5890
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Not Found

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a device called "Synaptic 3000". It does not contain information about acceptance criteria, device performance details, study design, or ground truth establishment. Therefore, I cannot extract the requested information from the provided text.

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).