COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM

K112441 · Daesung Maref Co., Ltd. · IRP · Jan 17, 2012 · Physical Medicine

Device Facts

• Record ID: K112441
• Device Name: COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM
• Applicant: Daesung Maref Co., Ltd.
• Product Code: IRP · Physical Medicine
• Decision Date: Jan 17, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MK300L 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 Story

Compressible Limb Therapy System MK300L is a powered inflatable tube massager used in clinical or home settings under medical supervision. The system utilizes four-chamber garments applied to the patient's limb. The power unit controls pneumatic inflation cycles, allowing for variable pressure, duration, and gradient settings. Visual indicators on the unit display operation status and fault conditions. By providing sequential compression, the device assists in managing edema and venous conditions, potentially improving patient outcomes through reduced swelling and improved circulation.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Powered inflatable tube massager; four-chamber garment system; variable pressure, duration, and cycle time controls. Complies with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), ISO 13485 (quality management), and ISO 14971 (risk management).

Indications for Use

Indicated for medical professionals and patients under medical supervision for treatment of primary lymphedema, edema following trauma/sports injuries, post-immobilization edema, venous insufficiencies, and lymphedema.

Regulatory Classification

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.

Predicate Devices

• Lympha press plus (K013331)
• LX-7 (K012320)
• WIC-2008 (K102319)

Submission Summary (Full Text)

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## 510(K) SUMMARY

[as required by 807.92(c)]

JAN 1 7 2012

#### A. 510k Number:

### B. Applicant:

Company name: PATS CORP Address: 205 S Broadway, Suite 718, Los Angeles California 90012 USA Contact person: Daniel Nam Phone: [phone]

C. Proprietary and Established Names: DAESUNG MAREF CO LTD Address: 689-31 Gumjung-dong, Gunpo-si Gyeonggi-do 451-864 KOREA

#### D. Regulatory Information

- 1. Classification Name: Massager, Powered Inflatable Tube
- 2. Common / Usual Name: Powered Inflatable Tube Massager
- 3. Proprietary Name: Compressible Limb Therapy System MK300L
- 4. Classification / Product Code: Class II / IRP (21 CFR 890.5650)

#### E. Intended Use

MK300L 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

MK300L 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.

#### G. Substantial Equivalence Information

- 1. Predicate Device
- Predicate Device 1
- 510(k) number: K013331
- Name: Lympha press plus
- Classification: 2

Predicate Device 2

- 510(k) number: K012320
- Name: LX-7
- Classification: 2

Predicate Device 3

- 510(k) number: K102319
- Name: WIC-2008

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- Classification: 2

- 2. Comparison with predicate
Compressible Limb Therapy System MK300L has substantial equivalent intended use as the-market-cleared LX-7 and has substantial equivalent technological and performance characteristics with Lympha press plus and WIC-2008.After analyzing both bench as well as laboratory testing to applicable standards, it is the conclusion of Compressible Limb Therapy System MK300L 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)
MK300L has conducted and applied by standard of

- Council Directive 93/42/EEC of 14 June 1993 concerning medical devices .
- IEC 980:2003, Graphical symbols for use in the labeling of medical devices .
- IEC1041:1998, 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 60601-1-2, Medical electrical equipment Part 1: General . requirements for safety - Collateral standard: Electromagnetic compatibility -

Requirements and tests

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

Daesung Maref Co. Ltd. % PATS Corporation Mr. Daniel Nam 205 South Broadway, Suite 718 Los Angeles, California 90012

JAN 1 7 2012

Re: K112441

Trade/Device Name: Compressible Limb Therapy System MK300L Regulation Number: 21 CFR 890.5650 Regulation Name: Powered inflatable tube massager Regulatory Class: Class II Product Code IRP Dated: December 5, 2011 Received: December 9, 2011

Dear Mr. Nam:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becaused 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 conimeree prof to riay =classified in accordance with the provisions of the Federal Food, devices that have been totact) that do not require approval of a premarket approval application Drag, and obsince, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual the ree." The general conneces, good manufacturing practice, labeling, and prohibitions against regiountion, maning or arrange: 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 your device to additional controls. Existing major regulations affecting your device can it may be subject to additions, 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 I teast be actived that FDT I o teamination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You the ret of the Act's requirements, including, but not limited to: registration and linest comply with an the riot of the eart 801); medical device reporting (reporting of

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#### Page 2 -- Mr. Daniel Nam

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Sincerely yours,

Mark N. Melkerson

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

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# Indications for Use

510(k) Number (if known):

Device Name: Compressible Limb Therapy System MK300L

Indications For Use: MK300L 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.

X ____________________________________________________________________________________________________________________________________________________________________________ Prescription Use_ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Yung D. Luth

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

510(k) Number K112441