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Found 2 results

510(k) Data Aggregation

K Number

Device Name

HES ULTRASONIC THERAPY APPLIANCE, MODELS HS-3008 (1MHZ), HS3026 (2MHZ), HS-3040 (3MHZ)

Manufacturer

HWANG SUN ENTERPRISE CO., LTD.

Date Cleared

2005-07-14

(147 days)

Product Code

IMI

Regulation Number

890.5300

Why did this record match?

Applicant Name (Manufacturer) :

HWANG SUN ENTERPRISE CO., LTD.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

The HES® Ultrasonic Therapy Appliance generates deep heat within body tissues for the treatment of selected medical conditions such as temporary relief of minor pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.

Device Description

The HES® Ultrasonic Therapy Appliance generates deep heat within body tissues.

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K Number

Device Name

HES ULTRASONIC THERAPY APPLIANCE

Manufacturer

HWANG SUN ENTERPRISE CO., LTD.

Date Cleared

2004-08-04

(128 days)

Product Code

IMI

Regulation Number

890.5300

Why did this record match?

Applicant Name (Manufacturer) :

HWANG SUN ENTERPRISE CO., LTD.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

The HES® Ultrasonic Therapy Appliance generates deep heat within body tissues for the treatment of selected medical conditions such as temporary relief of minor pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.

Device Description

Not Found

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