COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM, MODEL WHF-314 (POWER-Q1000)

K080134 · Wonjin Mulsan Co., Ltd. · IRP · Jan 23, 2009 · Physical Medicine

Device Facts

• Record ID: K080134
• Device Name: COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM, MODEL WHF-314 (POWER-Q1000)
• Applicant: Wonjin Mulsan Co., Ltd.
• Product Code: IRP · Physical Medicine
• Decision Date: Jan 23, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The WHF-314 (POWER Q1000) device 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, Post immobilization edema, Venous insufficiencies, Lymphedema

Device Story

WHF-314 (POWER Q1000) is a compressible limb and circulation therapy system. It utilizes four-chamber garments applied to the legs to provide pneumatic compression. The power unit allows for variable settings of duration, pressure, cycle time, and gradient. It features visual indicators for operation status and fault detection. Used in clinical or home settings under medical supervision to treat lymphedema, edema, and venous insufficiency. The device provides mechanical compression to assist circulation and reduce swelling. It excludes arm, forearm, and chest chambers and does not incorporate software.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Powered inflatable tube massager; four-chamber garment system; variable pressure, cycle time, and gradient controls; visual status/fault indicators. Complies with IEC 60601-1, IEC 60601-2-10, and IEC 60601-1-2 standards.

Indications for Use

Indicated for patients requiring treatment for primary lymphedema, edema following trauma or sports injuries, post-immobilization edema, and venous insufficiencies. 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

• TALLEY INTERMITTENT UNIT WITH CALF APPLIATOR (K915638)
• Biotouch Massage Therapy System (K013061)

Submission Summary (Full Text)

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Koro134

### 510(K) SUMMARY

[as required by 807 92(c)]

JAN 2 3 2009

#### A 510k Number

- B Applicant
Company name WONJIN MULSAN Co , Ltd

Address Namdong Industrial complex 10B-7L 623-6 Namchon-dong,

Namdong-gu Incheon, Korea

Tel [phone]

- Fax [phone]
- C Proprietary and Established Names WONJIN MULSAN Co , Ltd
- D Regulatory Information

-Classification Class 2

-Product cord IRP

-Regulation Number 890 5650

- E Intended use
The WHF-314 (POWER Q1000) device 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, Post immobilization edema, Venous insufficiencies, Lymphedema

- Device Description E
WHF-314 (POWER Q1000) 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 status and fault indicators

- G Substantial Equivalence Information
Predicate Device

- K915638/K013061

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## - TALLEY INTERMITTENT UNIT WITH CALF APPLIATOR/ Biotouch Massage Therapy System -Classification Class 2

#### 2 Comparison with predicate

Based on the above, we conclude that the Compressible Limb and Circulation Therapy Systems (WHF-314 (POWER Q1000)) are substantially equivalent to the marketed predicate device, but (WHF-314 (POWER Q1000)) exclude the arm, forearm, chest chamber and software, and do not raise any new issues of safety or effectiveness

- H Standard / Guidance Document Referenced (if applicable)
- 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 2000/A1 2003, Medical devices - Application of risk management to medical devices
- . IEC 60601-1 1990/A1 93/A295/A13 96, Medical electrical equipment - Part 1 General requirements for safety (IEC 60601-1 1988/A1 91/A2 95)
- . IEC 60601-2-10 2000/A1 01, Medical electrical equipment - Part 2-10 Particular requirements for the safety of nerve and muscle stimulators
- IEC 60601-1-2 2001, Medical electrical equipment Part 1 . General requirements for safety - Collateral standard Electromagnetic compatibility -Requirements and tests
- l Performance Characteristics (If/when applicable)
- See the Exhibits ー

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Wonjin Mulsan Co , Ltd % PATS Corporation Mr Brandon Cho1 Flemington Court #155 La Mirada, Calıfornia 90638

Re K080134

Trade Name Compressible Limb and Circulation Therapy System WHF-314(POWER-Q1000) Regulation Number 21 CFR 890 5650 Regulation Names Powered inflatable tube massager Regulatory Class II Product Code IRP Dated December 28, 2008 Received January 14, 2009

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. Insting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteratıon

JAN 2 3 2009

If your device is classified (see above) into etther 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 Brandon Choi

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone] Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807 97) For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Brometric's (OSB's) Division of Postmarket Surveillance at [phone] For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone] You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or Internet address http //www fda gov/cdrh/industry/support/index html

Sincerely yours.

Mark M. Mulkerson

Mark N Melkerson 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

510(k) Number (if known)

Device Name Compressible Limb and Circulation Therapy System (WHF-314)

Indications for Use The WHF-314 (POWER Q1000) device 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, Post immobilization 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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Division of General, Restorative, and Neurological Devic

510(k) Number \multicolumn{1}{l}{K80134}