COMPRESSIBLE LIMB THERAPY SYSTEM

K113275 · Wonjin Mulsan Co., Ltd. · IRP · Feb 27, 2012 · Physical Medicine

Device Facts

• Record ID: K113275
• Device Name: COMPRESSIBLE LIMB THERAPY SYSTEM
• Applicant: Wonjin Mulsan Co., Ltd.
• Product Code: IRP · Physical Medicine
• Decision Date: Feb 27, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is indicated 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 injures, Postimmobilization edema, Venous insufficiencies, Lymphedema.

Device Story

Power-Q1000 Premium is a pneumatic pressure treatment system using four-chamber nylon garments for sequential limb compression. It aims to improve blood circulation and prevent blood clots. The device features a power unit with visual status and fault indicators, allowing variable pressure (0-240 mmHg), cycle time, and gradient settings. It is intended for use by medical professionals or patients at home under medical supervision. The system operates by repeatedly inflating sleeves to provide sequential compression therapy. The healthcare provider or patient sets the mode (A, B, C, D, E), interval, and duration (5-99 minutes) to manage edema and venous conditions. The device provides therapeutic benefit by facilitating lymphatic and venous return.

Clinical Evidence

Bench testing only. The device was tested for compliance with EN60601-1 (General safety), EN60601-2-10 (Nerve and muscle stimulators), and EN60601-1-2 (Electromagnetic compatibility). No clinical data provided.

Technological Characteristics

Pneumatic sequential compression system; 4-chamber nylon applicator garments; pressure range 0-240 mmHg; variable cycle time and gradient settings. Complies with EN ISO14971, EN60601-1, EN60601-2-10, and EN60601-1-2. Power source 220-240V 50/60Hz.

Indications for Use

Indicated for medical professionals and patients under medical supervision for treatment of primary lymphedema, edema following trauma/sports injuries, postimmobilization edema, venous insufficiencies, and lymphedema. Contraindicated for acute pulmonary edema, acute thrombophlebitis, acute congestive cardiac failure, acute infections, deep vein thrombosis, pulmonary embolism, wounds/lesions/tumors at application site, conditions where increased venous/lymphatic return is undesirable, and bone fractures/dislocations at application site.

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

• Compressible Limb Therapy system (WHF-324 POWER-Q1000 PLUS) (K100656)

Submission Summary (Full Text)

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FEB 2 7 2012

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# 510(k) Summary [As required by 807.92(c)]

Date of issue: Jan 25, 2012

## A. 510k Number

- B. Applicant/Applicant Company Name: BSR KOREA Corp. Company Name: DSR ROREA Corp:
Address: Migun Techno World 2 C-dong, 524, #533-1 Yongsan-dong, Yuseong-gu, Daejeon, KOREA. Tel: [phone] Fax:[phone] Contact person: Eileen Yang
- C. Proprietary and Established Names: WONJIN MULSAN Co., Ltd. Address: 10B-7L 623-6 Namchon-dong, Namdong-gu Incheon, 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 (Power-Q1000 Premium)
- 4. Classification /Product Code: Class 2, IRP(21 CFR 890.5650)
- E. Intended Use

Power-Q1000 Premium is intended for use by medical professionals and patients at home, Fower-Q1000 Trennant is meeting many conditions, such as: Primary lymphedema, Edema following trauma and sport injuries, Postimmobilization edema, Venous insufficiencies, Lymphedema.

#### F. Device Description

Device Deseription
Power Q1000 Premium 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.

| Name | Power-Q1000 Premium |
|-----------------|--------------------------------------------------------------------------------------------------------------------------|
| Pressure (mmHg) | 0~240mmHg |
| Mode | A, B, C, D(D1, D2, D3, D4), E selection. (The initial set : Mode A) |
| Interval | Interval : 0, 5, 10, 15, 20, 25, 30 sec, selection. (The initial set :<br>0sec) |
| Time(min) | Time(min) : 5~99min, selection. (The initial set : 15min) |
| Pressure Time | Pressure : 0~240mmHg, selection (The initial set : 200mmHg)<br>0~240 : A, B, D(D1, D2, D3, D4) Mode<br>0~130 : C, E Mode |

Technological characteristics

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K113275

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- H. Substantial Equivalence Information
- l. Predicate Device
- -510(k) Number: 100656

-510(R) Namber: 100050
-Name: Compressible Limb Therapy system(WHF-324 POWER-Q1000 PLUS) -Classification: 2

- 2. Comparison with predicate _________________________________________________________________________________________________________________________________________________

| Model Name | Power Q1000 Premium | WHF-324 (POWER-Q1000) (predicate device) |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | None yet | k100656 |
| Classification | Class II Device/ IRP (21 CFR 890. 5650) | Class II Device/ IRP (21 CFR 890. 5650) |
| Intended use | The device is indicated 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 injures, Postimmobilization edema, Venous insufficiencies, Lymphedema. | The device is indicated 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 injures, Postimmobilization edema, Venous insufficiencies, Lymphedema. |
| Description | Power Q1000 Premium is a pneumatic pressure treatment system that repeats expansion of sleeves to help blood circulation and prevent blood clots or clogs. | Power Q1000 PLUS is a pneumatic pressure treatment system that repeats expansion of sleeves to help blood circulation and prevent blood clots or clogs |
| Standard | EN ISO14971<br>EN60601-1<br>EN60601-2-10<br>EN60601-1-2 | EN ISO14971<br>EN60601-1<br>EN60601-2-10<br>EN60601-1-2 |
| Indications | Primary lymphedema, Edema following trauma and sport injuires, postimmobilization edema, Venous insufficiencies, Lymphedema. | Primary lymphedema, Edema following trauma and sport injuires, postimmobilization edema, Venous insufficiencies, Lymphedema. |
| Contraindications | Acute pulmonary edema<br>Acute throubophlebitis<br>Acute congestive cardiac failure<br>Acute infections, Deep vein thrombosis<br>Episodes of pulmonary embolism Wounds, lesions, or turmors at or in the vicinity of application | Acute pulmonary edema<br>Acute throubophlebitis<br>Acute congestive cardiac failure<br>Acute infections, Deep vein thrombosis<br>Episodes of pulmonary embolism Wounds, lesions, or turmors at or in the vicinity of application |
| | Where increased venous and<br>lymphatic return is undesirable,<br>Bone fractures or dislocation at<br>or in the vicinity of application | Where increased venous and<br>lymphatic return is undesirable,<br>Bone fractures or dislocation at<br>or in the vicinity of application |
| Mode of Compression | Sequential | Sequential |
| Power source | | Electricity Supply: 220-240V<br>50/60HZ |
| Therapy Time | 0~99 minutes | 0-30 minutes |
| Maximum and<br>Minimum Pressure | 0-240mm Hg | 0-300mm Hg |
| Number of Chambers | 4 Chambers for each unit | 4 Chambers for each unit |
| Compression<br>Applicator Garments | Nylon | Nylon |

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### J. Performance characteristics

The Model Power-Q1000 Premium has tested and meets the requirements of the following standard.

-EN60601-1, Medical electrical equipment - Part 1: General requirements for safety (IEC 60601-1:1988/A1:91/A2:9s)

-EN60601-2-10, Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators

-EN60601-1-2, Medical electrical equipment - Part 1: General requirements for safety -Collateral standard: Electromagnetic compatibility

#### K. Conclusion

Compressible Limb Therapy System WHF-324 (POWER-Q1000 PLUS)) has substantial equivalent intended use as the-market-cleared WHF-314(POWER-Q1000) and has substantial equivalent technological and performance characteristics. After analyzing Substantial equivately "connerogen" it is the conclusion of WONJIN MULSAN Co., Idol that Compressible Limb Therapy System (WHF-324 (POWER-Q10 PLUS)) is as safe and effective as the predicate devices, has few technological differences, but there are no new and chective as the productions any new safety and/or effectiveness concerns. mentations for about that it substantially equivalent to the predicate devices

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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### Public Health Service

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

FEB 2 7 2012

Wonjinmulsan Co., Ltd. % BSR Korea Ms. Eileen Yang D-524 Migun Techno World 2 533-1 Yongsan-Dongyuseong-Gu Daejeon Republic of Korea KS

Re: K113275

Trade/Device Name: Compressible Limb Therapy System Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: February 14, 2012 Received: February 14, 2012

Dear Ms. Yang:

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 I ou may , arons 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.

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# Page 2 - Ms. Eileen Yang

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); 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

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

all

Enclosure

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K113275

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# INDICATIONS FOR USE

510(k) Number (if known):

Model No. POWER-Q1000 Premium Device Name: Compressible Limb Therapy System

Indications for Use:

The device is indicated 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 injures, Postimmobilization edema, Venous insufficiencies, Lymphedema.

Prescription Use _ x (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

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510(k) Number. K113275