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K Number
K973914
Device Name
SENSE TECHNOLOGY INC. FRAS, SENSE TECHNOLOGY INC. PULSTAR
Manufacturer
SENSE TECHNOLOGY, INC.
Date Cleared
1998-06-30

(259 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

Indications for use of the PulStarFRAS include: musculoskeletal pain due to joint subluxation, restricted joint mobility, myofacial spasm, ligamentous strain.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a device called PulStarFRAS, indicating that it has been found substantially equivalent to a previously marketed device. It lists the indications for use but does not detail any performance metrics, studies, or acceptance criteria.

N/A