(164 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on basic device parameters and regulatory standards.
Yes
The device is intended for "treating many conditions, such as: Primary lymphedema, Edema following trauma and sport injuries, Postimmobilization edema, Venous insufficiencies, Lymphedema," which qualifies it as a therapeutic device.
No
The device description and intended use state that the WIC-2008 is used for treating conditions like lymphedema and edema, and it features variable settings for pressure and cycle time. It does not mention any function for diagnosing conditions or generating diagnostic information.
No
The device description explicitly mentions a "Power unit" and "four chamber garments," which are hardware components. The performance studies also reference standards related to electrical equipment and physical medical devices (IEC 60601-1, IEC 60601-2-10).
Based on the provided information, the WIC-2008 device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used for treating conditions like lymphedema and edema. This involves applying physical therapy (compression) to the body, not analyzing samples taken from the body.
- Device Description: The description mentions a power unit and four-chamber garments for the leg, which are components of a physical therapy device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostics.
- Anatomical Site: The device is applied to the limb (full leg), which is an external application, not an in vitro analysis.
- Predicate Device: The predicate device (K100656) is described as "Compressible Limb and Circulation Therapy Systems," which aligns with a physical therapy device, not an IVD.
In summary, the WIC-2008 is a therapeutic device used for physical treatment, not a diagnostic device that analyzes samples outside of the body.
N/A
Intended Use / Indications for Use
WIC-2008 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.
Product codes (comma separated list FDA assigned to the subject device)
IRP
Device Description
WIC-2008 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
leg
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professionals and patients at home, who are under medical supervision
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
WIC-2008has 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
K102319
Page 1 of 2
510(K) SUMMARY
[as required by 807.92(c)]
JAN 2 8 2011
A. 510k Number:
B. Applicant:
Company name: PATS CORP Address: 49 Candlewood Way, Buena Park, CA 90621, USA Contact person: Mr Brandon Choi Phone: 714-523-1592 Fax: 714-523-1592
C. Proprietary and Established Names: WON INDUSTRY CO LTD
Address: 22-5,Daeya-dong,Siheung-si,Gyeonggi-do, Korea
D. Regulatory Information
-
- Classification Name: Massager, Powered Inflatable Tube
-
- Common / Usual Name: Powered Inflatable Tube Massager
-
- Proprietary Name: Compressible Limb Therapy System WIC-2008
-
- Classification / Product Code: Class II / IRP (21 CFR 890.5650)
E. Intended Use
WIC-2008 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
WIC-2008 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
Predicate Device
- Classification: 2
- 510(k) number: K100656
- Name: Compressible Limb and Circulation Therapy Systems
(WHF-324 (POWER-Q1000 PLUS))
1. Comparison with predicate
Compressible Limb Therapy System WIC-2008 has substantial equivalent intended use as the-market-cleared WHF-324 (POWER-Q1000 PLUS) and has substantial equivalent technological and performance characteristics. After analyzing both bench as well as laboratory testing to applicable standards,
1
it is the conclusion of WON INDUSTRY Co Ltd. that Compressible Limb Therapy System WIC-2008 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. Concerns. Concerns it is clear that it substantially equivalent to the predicate devices
102319
page 2 of 2
H. Performance Characteristics (If/when applicable)
WIC-2008has 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
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three tail feathers, representing the department's commitment to health, services, and human well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Contro} Room -WO66-G609 Silver Spring, MD 20993-0002
Won Industrial Co. % PATS Corporation Mr. Brandon Choi 205 S. Broadway, Suite 718 Los Angeles, CA 90012
JAN 2 8 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 -
Re: K102319
Trade/Device Name: Compressible Limb Therapy System WIC-2008 Regulation Number: 21 CFR 890.5650 Regulation Name: Powered inflatable tube massager Regulatory Class: Class II Product Code: IRP Dated: January 20, 2011 Received: January 25, 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 (Act do not require approval of a provisions of the Pederal Food, Drug,
You may, therefore, market the desires and in a premarket approval application ( 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 misling 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 of class III (PMA)
found in the Code of Foderal Parchives Titler Titler 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
3
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 fou 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" (2) CFR 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
A. B. R.
for.
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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