COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL LX7(V7)

K102320 · Daesung Maref Co., Ltd. · IRP · Mar 4, 2011 · Physical Medicine

Device Facts

• Record ID: K102320
• Device Name: COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL LX7(V7)
• Applicant: Daesung Maref Co., Ltd.
• Product Code: IRP · Physical Medicine
• Decision Date: Mar 4, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

LX7(V7) 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 LX7(V7) is a powered inflatable tube massager; provides sequential compression therapy to limbs using four to eight chamber garments. Power unit controls variable duration, pressure (0-230mmHg), cycle time, and gradient settings; features visual operation status and fault indicators. Used in clinical or home settings under medical supervision. Device applies pneumatic pressure to limbs to treat edema and venous conditions; helps reduce fluid accumulation; improves circulation. Healthcare providers prescribe therapy parameters; patients operate device at home. Benefits include management of lymphedema and post-traumatic swelling.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench and laboratory testing to international standards, including EN 60601-1 (safety), EN 60601-2-10 (nerve/muscle stimulators), and EN 60601-1-2 (EMC).

Technological Characteristics

Powered inflatable tube massager; 4-8 chamber nylon garments. Sequential compression mode. Pressure range 0-230mmHg. Power: 230V, 50/60Hz. Standards: EN ISO 14971, EN 60601-1, EN 60601-2-10, EN 60601-1-2, IEC 980, IEC 1041, ISO 13485, ISO 14155-1.

Indications for Use

Indicated for patients with primary lymphedema, edema following trauma or sports injuries, post-immobilization edema, venous insufficiencies, and lymphedema. Intended for use by medical professionals or patients at home under medical supervision.

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)
• Compressible Limb and Circulation Therapy Systems (K100656)

Submission Summary (Full Text)

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K102320
Page 1 of 3

MAR - 4 2011

## 510(K) SUMMARY

[as required by 807.92(c)]

### A. 510k Number:

- B. Applicant:
Company name: PATS CORP Address: 49 Candlewood Way, Buena Park, CA 90621, USA Contact person: Mr Brandon Choi Phone: [phone] Fax: [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 LX7(V7)
- 4. Classification / Product Code: Class II / IRP (21 CFR 890.5650)

#### E. Intended Use

LX7(V7) 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

LX7(V7) 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: K100656
- Name: Compressible Limb and Circulation Therapy Systems

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K102320
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# (WHF-324 (POWER-Q1000 PLUS))

# 2. Comparison with predicate

| Model Name | LX7(V7) | Lympha press plus | WHF-324<br>(POWER-Q1000 Plus) |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | None yet | K013331 | K100656 |
| Classification | Class II Device / IRP (21<br>CFR 890.5650) | Class II Device / JOW (21<br>CFR 870.5800) | Class II Device / IRP (21<br>CFR 890.5650) |
| Intended Use | LX7(V7) is intended for<br>use by medical<br>professionals and patients<br>at home, who are under<br>medical supervision, in<br>treating many conditions,<br>such as:<br>Primary lymphedema,<br>Edema following trauma<br>and sport injuries, Post<br>immobilization edema,<br>Venous insufficiencies,<br>Lymphedema. | Treatment of Lymphatic<br>disorders, Venous disorder,<br>Post-mastectomy<br>Lymphedema and<br>Dysfunction of the Muscle<br>Pump. | The WHF-324 (POWER<br>Q1000 Plus) device is<br>intended for use by medical<br>professionals and patients<br>at home, who are under<br>medical supervision, in<br>treating many conditions,<br>such as:<br>Primary lymphedema,<br>Edema following trauma<br>and sport injuries,<br>Post immobilization edema,<br>Venous insufficiencies,<br>Lymphedema. |
| Standard | EN ISO 14971<br>EN 60601-1<br>EN 60601-2-10<br>EN 60601-1-2 | EN ISO 14971<br>EN 60601-1<br>EN 60601-2-10<br>EN 60601-1-2 | EN ISO 14971<br>EN 60601-1<br>EN 60601-2-10<br>EN 60601-1-2 |
| Indications | Primary lymphedema,<br>Edema following trauma<br>and sport injuries,<br>Postimmobilization<br>edema,<br>Venous insufficiencies,<br>Lymphedema. | - | Primary lymphedema,<br>Edema following trauma<br>and sport injuries,<br>Post immobilization edema,<br>Venous insufficiencies,<br>Lymphedema. |
| Mode of<br>Compression | Sequential | Sequential | Sequential |
| Mode description | 2 modes | 2 modes<br>(Lympha, Gradient12,<br>Wave, Ballancer, and<br>Pre-Therapy) | 1 mode |
| Power Source | Electricity Supply:<br>230 V~,50/60 Hz<br>Electricity<br>consumption: ,35W | Electricity Supply:<br>230 V~,50/60 Hz | Electricity Supply:<br>220~240V 50/60Hz<br>consumption: 25 watts |
| Therapy Time | 0-30 minutes | 0-10 minutes | 0-30 minutes |
| Maximum and<br>Minimum<br>Pressure | 0-230mmHg | 0-200mmHg | 0-235mmHg |
| Number of<br>Chambers | 4 to 8 chamber | 12 chamber | 4 to 8 chamber |
| Compression<br>Cycle Time | 30min | 30 min | 30min |
| Garments Sleeve<br>Material | Nylon | - | Nylon |

3. Conclusion

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K102320
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Compressible Limb Therapy System (LX7(V7)) has substantial equivalent intended use as the-market-cleared WHF-324 (POWER-Q1000 Plus) and has substantial equivalent technological and performance characteristics with Lympha Press plus .

After analyzing both bench as well as laboratory testing to applicable standards, it is the conclusion of Compressible Limb Therapy System (LX7(V7)) 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)

- LX7(V7)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 60601-2-10, 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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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

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. Brandon Choi 205 S. Broadway, Suite 718 Los Angeles, CA 90012

MAR - 4 2011

Re: K102320

Trade/Device Name: Compressible Limb Therapy System LX7(V7) Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: February 25, 2011 Received: March 1, 2011

Dear Mr. Choi:

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 comply with all the Act's requirements, including, but not limited to: registration and listing (21

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#### Page 2 - Mr. Brandon Choi

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

Sincerely yours,

Aling B. R. Ja.

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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# Indications for Use

510(k) Number (if known): | | | | | 2 3 2 2

Device Name: Compressible Limb Therapy System LX7(V7)

Indications For Use: LX7(V7) 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 × (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)

Sign-Off

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

510(k) Number K102320