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.

AI/ML Overview

This 510(k) premarket notification (K032449) is for a physical therapy table, not an AI/ML powered device. As such, information regarding AI/ML specific acceptance criteria, study designs, sample sizes for test and training sets, expert qualifications, adjudication methods, or MRMC studies for AI performance is not present in the provided document.

The "Performance Data" section of the document describes the device's compliance with safety and electrical standards, which serve as its acceptance criteria.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Standard)	Reported Device Performance
UL 2601 2nd Edition (1997) "Medical Electrical Equipment, Part 1: General Requirements for Safety 2nd Edition Including Amendments 1 and 2"	The Model HY5000 Thermassage Energy Product has been tested to and meets the requirements of this standard.
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"	The Model HY5000 Thermassage Energy Product has been tested to and meets the requirements of this standard.
EN 60601-1 (1990), "Medical Electrical Equipment Part 1, General Requirements for Safety including Amendments A1 and A2"	The Model HY5000 Thermassage Energy Product has been tested to and meets the requirements of this standard.
IEC 60601-1, 2nd Edition (1998) "Medical Equipment General requirements for Safety + A1:91 and A2:95."	The Model HY5000 Thermassage Energy Product has been tested to and meets the requirements of this standard.
IEC 60601-2-38 1st Edition (1996) "Medical Electrical Equipment Part 2: Particular Requirements for the Safety of Electrically Operated Beds."	The Model HY5000 Thermassage Energy Product has been tested to and meets the requirements of this standard.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable and is not provided in the document. The performance data is based on compliance with electrical and safety standards, not on clinical testing with a patient sample set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and is not provided in the document. "Ground truth" in the context of expert consensus is relevant for diagnostic or AI/ML performance studies, not for the safety and electrical compliance of a physical therapy table. The "experts" in this context would be the testing laboratories and engineers who verify compliance with the specified standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and is not provided in the document. Adjudication methods are typically used in clinical studies or for establishing ground truth in AI/ML performance evaluations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This information is not applicable as the device is a physical therapy table, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

No. This information is not applicable as the device is a physical therapy table and does not involve an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable in the context of the provided document. The "ground truth" for this device's performance is its conformity to established international safety and electrical standards, as demonstrated through testing by accredited bodies (e.g., Underwriters Laboratories).

8. The sample size for the training set

This information is not applicable as the device is a physical therapy table and does not involve AI or machine learning that would require a training set.

9. How the ground truth for the training set was established

This information is not applicable as the device is a physical therapy table and does not involve AI or machine learning that would require a training set or its associated ground truth establishment.

Summary

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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: (561) 563-9800 Fax: (561) 564-9666

Sponsor

Migun Medical Instrument Co., LTD Dae-Jun City Dong-Ku, Yong-Jun Dong 68-21 South Korea Phone: 82-42-222-3340 Fax: 82-42-623-0507

Contact Person

Edward A. Kroll Representative Consultant for Migun Medical Spectre Solutions, Inc. 5905 Fawn Lane Cleveland, Ohio 44141 Phone: (440) 546-9810 Fax: (330) 253-4374

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

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K032 449/51

Predicate Devices

1. LSI International's Quantum Intersegmental Roller Traction Table (K002390)
1. 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

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"
1. 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"
1. EN 60601-1 (1990), "Medical Electrical Equipment Part 1, General Requirements for Safety including Amendments A1 and A2'
1. IEC 60601-1, 200 Edition (1998) "Medical Equipment General requirements for Safety + A1:91 and A2:95."
1. IEC 60601-2-38 157 Edition (1996) "Medical Electrical Equipment Part 2: Particular Requirements for the Safety of Electrically Operated Beds."

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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.

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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 (301) 594-1308. 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 (800) 638-2041 or (301) 443-6597 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

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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

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Number K032944

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).