WIC -2008S is intended for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as : Primary lymphedema, Edema following trauma and sport injuries, Postimmobilization edema, Venous insufficiencies, Lymphedema.

Device Description

WIC-2008S is used with four chamber garments for full leg, and period has its own variable duration,pressure, cycle time and gradient setting. Power unit features visual operation statusand fault indicators.

AI/ML Overview

This document describes a medical device, the Compressible Limb Therapy System WIC-2008S, which is a "Powered inflatable tube massager." The submission is for a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a predicate device, not necessarily to prove efficacy through extensive clinical trials.

Therefore, the provided text does not contain information about acceptance criteria, detailed device performance metrics, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth for training sets was established.

The document focuses on:

Device Description: It's a system that uses four-chamber garments for full legs and has variable duration, pressure, cycle time, and gradient settings.
Intended Use: To treat conditions like primary lymphedema, edema following trauma and sports injuries, post-immobilization edema, venous insufficiencies, and lymphedema.
Substantial Equivalence: The primary argument is that the WIC-2008S is substantially equivalent to a previously cleared device (WIC-2008, K102319) in terms of intended use, technological, and performance characteristics, without raising new safety or effectiveness concerns.
Performance Characteristics (Standards Applied): Instead of reporting specific device performance against acceptance criteria, the document lists a series of national and international standards the device has conducted and applied, which are common for medical devices to ensure safety, quality, and regulatory compliance. These standards include:
- Council Directive 93/42/EEC (Medical Devices)
- IEC 980:2008 (Graphical symbols for use in labeling)
- IEC 1041:2008 (Information supplied by manufacturer)
- ISO 13485:2003 (Quality management systems)
- ISO 14155-1:2003 (Clinical investigation of medical devices for human subjects - General requirements)
- ISO 14971:2007 (Application of risk management)
- IEC 60601-1 (General requirements for safety of medical electrical equipment)
- IEC 60601-2-10 (Particular requirements for safety of nerve and muscle stimulators)
- IEC 60601-1-2 (Electromagnetic compatibility)

Conclusion:

Based on the provided text, it's not possible to populate the requested table or answer most of the questions, as this is a 510(k) submission focused on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria often seen for novel devices that require efficacy data.

The "performance characteristics" listed are the standards applied (bench and laboratory testing to applicable standards), not specific performance metrics like sensitivity, specificity, accuracy, or effect sizes from clinical studies. The FDA's letter explicitly states that they "have determined the device is substantially equivalent... to legally marketed predicate devices," which means they accepted the manufacturer's argument based on design, materials, and engineering testing to relevant safety standards, rather than new clinical outcome studies.

Therefore, the requested information (performance acceptance criteria, sample sizes, ground truth, expert qualifications, MRMC studies, etc.) is not present in the provided 510(k) summary.

Summary

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510(K) SUMMARY

Pg 1 of 2

[as required by 807.92(c)]

A. 510k Number:

B. Applicant:

Company name: PATS CORP Address: 4568 W. 1st Street, Suite 104 Los Angeles, CA 90004, USA Contact person: Mr Daniel Nam Phone: 213-626-1544 FAX: 213-626-1548

C. Proprietary and Established Names: WON INDUSTRY CO LTD

Address: 22-5,Daeya-dong,Siheung-si,Gyeonggi-do, Korea

D. Regulatory Information

1. Classification Name: Massager, Powered Inflatable Tube
1. Common / Usual Name: Powered Inflatable Tube Massager
1. Proprietary Name: Compressible Limb Therapy System WIC-2008S
1. Classification / Product Code: Class II / IRP (21 CFR 890.5650)

E. Intended Use

WIC-2008S is intended for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as : Primary lymphedema, Edema following trauma and sport injuries, Postimmobilization edema, Venous insufficiencies, Lymphedema.

F. Device Description

G. Substantial Equivalence Information

Predicate Device

510(k) number: K102319
Name: Compressible Limb and Circulation Therapy Systems

(WIC-2008)

Classification: 2
1. Comparison with predicate

Compressible Limb Therapy System WIC-2008S has substantial equivalent intended use as the-market-cleared Compressible Limb Therapy System WIC-2008 and has substantial equivalent technological and performance characteristics.

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K120166
Pg 2 of 2

After analyzing both bench as well as laboratory testing to applicable standards, it is the conclusion of WON INDUSTRY Co Ltd. that Compressible Limb Therapy System WIC-2008S is as safe and effective as the predicate devices, has few technological differences, but there are no new indications for use and without raising any new safety and/or effectiveness concerns. Consequently, it is clear that it substantially equivalent to the predicate devices

H. Performance Characteristics (If/when applicable)

WIC-2008has conducted and applied by standard of

Council Directive 93/42/EE.C of 14 June 1993 concerning medical devices .
IEC 980:2008, Graphical symbols for use in the labeling of medical devices
IEC1041:2008, Information supplied by the manufacturer with medical devices
ISO 13485:2003. Medical devices Quality management systems -Requirements for regulatory purposes
ISO 14155-1:2003, Clinical investigation of medical devices for human subjects - Part 1: General requirements
ISO 14971:2007, Medical devices Application of risk management to medical devices
IEC 60601-1. Medical electrical equipment Part 1: General requirements for safety (IEC 60601-1:1988/A1:91/A2:95)
IEC 60601-2-10, Medical electrical equipment Part 2-10: Particular requirements for the safety of nerve and muscle stimulators
IEC 60601-1-2, Medical electrical equipment Part 1: General requirements for safety - Collateral standard: Electromagnetic compatibility -Requirements and tests

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized eagle with outstretched wings, with three wavy lines below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAY 1 4 2012

Won Industrial Co. % PATS Corporation Mr. Daniel Nam 4568 West 1st Street, Suite 104 Los Angeles, California 90004

Re: K120166

Trade/Device Name: Compressible Limb Therapy System WIC-2008S Regulation Number: 21 CFR 890.5650 Regulation Name: Powered inflatable tube massager Regulatory Class: Class II Product Code: IRP Dated: April 27, 2012 Received: May 3, 2012

Dear Mr. Nam:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Mr. Daniel Nam

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

fee-0616
ns. lr
ns. R

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K120166
pg 1 of 1

Indications for Use

510(k) Number (if known):

Device Name: Compressible limb therapy system WIC-2008S

Indications for Use: WIC -2008S is intended for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as : Primary lymphedema, Edema following trauma and sport injuries, Postimmobilization edema, Venous insufficiencies, Lymphedema.

Prescription Use AND/OR Subpart D) (21 CFR 801 Subpart C) Over-The-Counter Use ______ (Part 21 CFR 801

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K120166

Regulation Number and Section

§ 890.5650 Powered inflatable tube massager.

(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).