(371 days)
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
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
The provided 510(k) summary for the WONJIN MULSAN Co., Ltd. WHF-314 (POWER Q1000) device does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria.
The document is a submission for substantial equivalence to a predicate device, focusing on regulatory information, intended use, device description, and a comparison with the predicate. There is no mention of a performance study, clinical trial, or any data presented to establish device performance against predefined acceptance criteria.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and the reported device performance: This information is not present.
- Sample size used for the test set and the data provenance: This information is not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
- Adjudication method: This information is not present.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: This information is not present.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This information is not present.
- The type of ground truth used: This information is not present.
- The sample size for the training set: This information is not present.
- How the ground truth for the training set was established: This information is not present.
The document primarily focuses on establishing substantial equivalence based on the device's design, intended use, and comparison to existing devices, rather than presenting new performance data. The section "Performance Characteristics (If/when applicable)" explicitly states "See the Exhibits," but these exhibits are not included in the provided 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 +82 32 816 0552
- Fax +82 32 816 0557
- 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
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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 (240) 276-0120 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 (240) 276-3474 For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464 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 (800) 638-2041 or (240) 276-3150 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}
§ 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).