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510(k) Data Aggregation

K Number

Device Name

RICH-MAR US500, US750, US1000 THERAPEUTIC UNLTRASOUND DEVICES

Manufacturer

Date Cleared

1998-11-19

(121 days)

Product Code

Regulation Number

Type

Panel

Physical Medicine

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

RICH-MAR US500, US750, US1000 THERAPEUTIC UNLTRASOUND DEVICES

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Rich-Mar Ultrasound devices are indicated to produce therapeutic deep heat for the following conditions:

l) Relief of pain
1. Muscle Spasms
1. Joint contractures
  But NOT for the treatment of malignancies

Device Description

Rich-Mar US500, US750, US1000, Therapeutic Ultrasound Devices

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for therapeutic ultrasound devices. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. Therefore, I cannot fulfill your request based on the provided text.

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