THERMASSAGE ENERGY PRODUCT, MODEL HY5000

• K Number: K032449
• Device Name: THERMASSAGE ENERGY PRODUCT, MODEL HY5000
• Manufacturer: MIGUN MEDICAL INSTRUMENT CO. LTD.
• Date Cleared: 2003-10-22 ( 75 days)
• Product Code: JFB ILY
• Regulation Number: 890.5880

Intended Use

The intended use of the Migun Model HY5000 Thermassage Energy Product is to provide patients with muscle relaxation therapy by delivering heat and soothing massage. Additionally, the infrared lamps provide topical heating for; - temporary relief of minor muscle and joint pain, and stiffness o - the temporary relief of minor joint pain associated with arthritis o - the temporary increase in local circulation where applied O - relaxation of muscles o

Device Description

The Migun Model HY5000 Thermassage Energy Product is an electrically powered, motorized, multifunctional physical therapy table. It's intended function and use is to provide patients with muscle relaxation therapy by delivering heat and soothing massage. The massage function is delivered by way of two (2) independent carriages, which are mounted under a pad of the table torso section. The heat function is delivered by use of ten (10) infrared lights, which are mounted directly to the traversing carriages. Each carriage has five (5) infrared lights. During use, these carriages traverse from lower torso to upper torso and apply light pressure as well as heat to the supine user.

Predicate Devices

K002390, K933443

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use focus on mechanical and thermal therapy, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".

Therapeutic

Yes
The device is described as a "multifunctional physical therapy table" that provides "muscle relaxation therapy" and "topical heating for temporary relief of minor muscle and joint pain, and stiffness" and other therapeutic benefits, which are characteristic descriptions of a therapeutic device.

Diagnostic

No

The device is described as a physical therapy table delivering heat and massage for muscle relaxation and temporary pain relief, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is an "electrically powered, motorized, multifunctional physical therapy table" with physical components like carriages, infrared lights, and a pad. This indicates it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
• Device Function: The Migun Model HY5000 Thermassage Energy Product is a physical therapy table that applies heat and massage externally to the patient's body. It does not analyze any biological samples.
• Intended Use: The intended use is for muscle relaxation, pain relief, increased circulation, and muscle relaxation through external application of heat and massage. These are not diagnostic purposes based on analyzing biological samples.

Therefore, the device's function and intended use clearly fall outside the scope of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The intended use of the Migun Model HY5000 Thermassage Energy Product is to provide patients with muscle relaxation therapy by delivering heat and soothing massage. Additionally, the infrared lamps provide topical heating for;

• temporary relief of minor muscle and joint pain, and stiffness
• the temporary relief of minor joint pain associated with arthritis
• the temporary increase in local circulation where applied
• relaxation of muscles

Product codes

JFB, ILY

Device Description

The Migun Model HY5000 Thermassage Energy Product is an electrically powered, motorized, multifunctional physical therapy table. It's intended function and use is to provide patients with muscle relaxation therapy by delivering heat and soothing massage.

The massage function is delivered by way of two (2) independent carriages, which are mounted under a pad of the table torso section. The heat function is delivered by use of ten (10) infrared lights, which are mounted directly to the traversing carriages. Each carriage has five (5) infrared lights. During use, these carriages traverse from lower torso to upper torso and apply light pressure as well as heat to the supine user.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The Model HY5000 Thermassage Energy Product has been tested to and meets the requirements of the following standards.

• 1. Underwriters Laboratories (U.L.) Standard UL 2601 2nd Edition (1997) "Medical Electrical Equipment, Part 1: General Requirements for Safety 2nd Edition Including Amendments 1 and 2"
• 2. CAN/CSA C22.2 No. 601.1-M90, "Medical Equipment-Part 1: General Requirements for Safety, including C22.2 No. 601.1S1-94. IEC 601.1. Amendment, 1:1991 Supplement No. 1-94 to CAN/CSA 22.2 No. 601.1-M90"
• 3. EN 60601-1 (1990), "Medical Electrical Equipment Part 1, General Requirements for Safety including Amendments A1 and A2'
• 4. IEC 60601-1, 200 Edition (1998) "Medical Equipment General requirements for Safety + A1:91 and A2:95."
• 5. IEC 60601-2-38 157 Edition (1996) "Medical Electrical Equipment Part 2: Particular Requirements for the Safety of Electrically Operated Beds."

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K002390, K933443

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 890.5880 Multi-function physical therapy table.

(a)
Identification. A multi-function physical therapy table is a device intended for medical purposes that consists of a motorized table equipped to provide patients with heat, traction, and muscle relaxation therapy.(b)
Classification. Class II (performance standards).

Summary

0

K03 2449

510(k) SUMMARY

Migun Corporation's Model HY5000 Thermassage Energy Product

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.

Submitter

John K. Purvis Noninvasive Health Products, Inc. 1875 Fourteenth Avenue Vero Beach, Florida 32960 Telephone: [phone] Fax: [phone]

Sponsor

Migun Medical Instrument Co., LTD Dae-Jun City Dong-Ku, Yong-Jun Dong 68-21 South Korea Phone: [phone] Fax: [phone]

Contact Person

Edward A. Kroll Representative Consultant for Migun Medical Spectre Solutions, Inc. 5905 Fawn Lane Cleveland, Ohio 44141 Phone: [phone] Fax: [phone]

Date Prepared: August 5, 2003

Name of Device: Model HY5000 Thermassage Energy Product

Common or Usual Name Massage Therapy Table

Classification Name

Multi-Functional Physical Therapy Table

1

K032 449/51

Predicate Devices

• 1. LSI International's Quantum Intersegmental Roller Traction Table (K002390)
• 2. Williams Healthcare's Combi 2.5 Intersegemental Traction Table (K933443)

Intended Use

The intended use of the Migun Model HY5000 Thermassage Energy Product is to provide patients with muscle relaxation therapy by delivering heat and soothing massage. Additionally, the device includes infrared lamps which emit energy in the infrared spectrum, and provide topical heating for the purpose of elevating tissue for the temporary relief of minor muscle and joint pain, and stiffness.

Device Description

The Migun Model HY5000 Thermassage Energy Product is an electrically powered, motorized, multifunctional physical therapy table. It's intended function and use is to provide patients with muscle relaxation therapy by delivering heat and soothing massage.

The massage function is delivered by way of two (2) independent carriages, which are mounted under a pad of the table torso section. The heat function is delivered by use of ten (10) infrared lights, which are mounted directly to the traversing carriages. Each carriage has five (5) infrared lights. During use, these carriages traverse from lower torso to upper torso and apply light pressure as well as heat to the supine user.

PERFORMANCE DATA

The Model HY5000 Thermassage Energy Product has been tested to and meets the requirements of the following standards.

• 1. Underwriters Laboratories (U.L.) Standard UL 2601 2nd Edition (1997) "Medical Electrical Equipment, Part 1: General Requirements for Safety 2nd Edition Including Amendments 1 and 2"
• 2. CAN/CSA C22.2 No. 601.1-M90, "Medical Equipment-Part 1: General Requirements for Safety, including C22.2 No. 601.1S1-94. IEC 601.1. Amendment, 1:1991 Supplement No. 1-94 to CAN/CSA 22.2 No. 601.1-M90"
• 3. EN 60601-1 (1990), "Medical Electrical Equipment Part 1, General Requirements for Safety including Amendments A1 and A2'
• 4. IEC 60601-1, 200 Edition (1998) "Medical Equipment General requirements for Safety + A1:91 and A2:95."
• 5. IEC 60601-2-38 157 Edition (1996) "Medical Electrical Equipment Part 2: Particular Requirements for the Safety of Electrically Operated Beds."

2

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a human figure with three arms or wings extending upwards.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 2 2003

Migun Medical Instrument Co., Ltd. C/o Mr. Edward A. Kroll Spectre Solutions, Inc. 5905 Fawn Lane Cleveland, Ohio 44141

Re: K032449

Trade/Device Name: Migun HY5000 Thermassage Energy Product Regulation Number: 21 CFR 890.5880, 21 CFR 890.5500 Regulation Name: Multi-function physical therapy table, Infrared lamp Regulatory Class: II Product Code: JFB, ILY Dated: September 24, 2003 Received: September 26, 2003

Dear Mr. Kroll:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

3

Page 2 - Mr. Edward A. Kroll

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

L. Mark N. Melkerson

Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

4

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): TBD

Device Name: Migun HY5000 Thermassage Energy Product

Indications For Use:

• The intended use of the Migun Model HY5000 Thermassage Energy . Product is to provide patients with muscle relaxation therapy by delivering heat and soothing massage. Additionally, the infrared lamps provide topical heating for;
  • temporary relief of minor muscle and joint pain, and stiffness o
  • the temporary relief of minor joint pain associated with arthritis o
  • the temporary increase in local circulation where applied O
  • relaxation of muscles o

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

Mark A. Milkman

vision Sign-Off ision of ! Pestorative

102000 10000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

Number K032944