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K Number
K974376
Device Name
JTECH ADJUSTER REFLEX GUN
Manufacturer
J-TECH MEDICAL, INC.
Date Cleared
1998-02-18

(90 days)

Product Code
LXM
Regulation Number
N/A
Type
Traditional
Panel
PM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The JTECH Adjuster Reflex Gun is designed to be used when the practitioner deems manual adjustment not to be effective, possible or desirable. It can be used for stimulating segments of the cervical spine, thoracic spine and lumbar spine as well as the sacrum, ilium and extremities.

Device Description

JTECH Adjuster Reflex Gun

AI/ML Overview

I'm sorry, I cannot fulfill your request to describe the acceptance criteria and study proving device performance based on the provided text. The document is an FDA 510(k) clearance letter for the "JTECH Adjuster Reflex Gun," indicating it has been found "substantially equivalent" to predicate devices. This type of document does not contain the detailed information you're asking for regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert qualifications.

The letter focuses on regulatory clearance, not on providing the results of a specific performance study against defined acceptance criteria. Therefore, I cannot extract the requested information from the given text.

N/A