(79 days)
Not Found
No
The summary describes a compressible limb therapy system with adjustable pressure, cycle time, and gradient settings. There is no mention of AI, ML, image processing, or any data-driven learning capabilities. The performance studies focus on compliance with standards and equivalence to a predicate device, not on AI/ML performance metrics.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use... in treating many conditions" such as lymphedema, trauma and sports injuries, and venous insufficiencies, which are therapeutic applications. Additionally, the device is referred to as a "Compressible Limb Therapy System" in the performance studies section.
No
The "Intended Use / Indications for Use" section states that the device is intended for "treating many conditions," such as lymphedema, edema, and venous insufficiencies. This indicates a therapeutic or treatment purpose, rather than a diagnostic one.
No
The device description explicitly mentions a "Power unit" and "four chamber garments," indicating physical hardware components beyond just software. The performance studies also reference standards related to electrical equipment and physical devices.
Based on the provided information, this 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 is a therapeutic application, not a diagnostic one.
- Device Description: The description details a system that uses compression garments and controls pressure and cycle time. This is consistent with a physical therapy or treatment device, not a device that analyzes samples from the body.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
- Regulatory Standards: The listed regulatory standards (Council Directive 93/42/EEC, IEC 60601 series, ISO 13485, etc.) are typical for medical devices used for treatment or physical therapy, not specifically for in vitro diagnostics.
In vitro diagnostics are devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
WHF-324 (POWER-Q1000 PLUS) 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
WHF-314 (POWER Q1000) is Used with four chamber garments for full leg, and period has its own variable duration.pressure, cvcle 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
Not Found
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)
Not Found
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
MAY 2 6 2010
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: 714-523-1592 Fax: 714-523-1592
C. Proprietary and Established Names: WONJIN MULSAN Co., Ltd Address: 10B-7L 623-6 Namchon-dong, Namdong-gu Incheon, Korea
D. Requlatory Information
-
- Classification Name: Massager, Powered Inflatable Tube
- Common / Usual Name: Powered Inflatable Tube Massager 2.
- ဒေ Proprietary Name: Compressible Limb Therapy System (WHF-324 (POWER-Q1000 PLUS))
- ধ, Classification / Product Code: Class II / IRP (21 CFR 890.5650)
E. Intended Use
WHF-324 (POWER-Q1000 PLUS) 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
WHF-314 (POWER Q1000) is Used with four chamber garments for full leg, and period has its own variable duration.pressure, cvcle time and gradient setting. Power unit features visual operation statusand fault indicators.
G. Substantial Equivalence Information
-
- Predicate Device
- 510(k) number: K080134
- Name: Compressible Limb and Circulation Therapy Systems (WHF-314
(POWER-Q1000))
- Classification: 2
2. Comparison with predicate
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
1
performance characteristics.
After analyzing both bench as well as laboratory testing to applicable standards, it is the conclusion of WONJIN MULSAN Co., Ltd. that Compressible Limb Therapy System (WHF-324 (POWER-Q1000 PLUS)) 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)
WONJIN MULSAN Co., Ltd. that Compressible Limb Therapy System (WHF-324 (POWER-Q1000 PLUS)) 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 60601-2-10:2000/A1:01, Medical electrical equipment Part 2-10: Particular requirements for the safety of nerve and muscle stimulators
- IEC 60601-1-2:2001/A1:2006, 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 logo for the Department of Health & Human Services - USA. The logo consists of a stylized image of an eagle or other bird with outstretched wings. The bird is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 2 5 2010
Wonjin Mulsan Co., Ltd. % Pats Corporation Mr. Brandon Choi 49 Candlewood Way Buena Park, California 90621
Re: K100656
Trade/Device Name: Compressible Limb Therapy System (WHF-324 (POWER-01000 PLUS)) Regulation Number: 21 CFR 890.5650 Regulation Name: Powered inflatable tube massager Regulatory Class: II Product Code: IRP Dated: May 1, 2010 Received: May 6, 2010
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
3
Page 2 - Mr. Brandon Choi
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 (800) 638-2041 or (301) 796-7100 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
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Compressible Limb Therapy System (WHF-324 (POWER-Q1000 PLUS))
Indications For Use: WHF-324 (POWER-Q1000 PLUS) is intended for use by WHF-324 (r OWEN & 1000 P & 000) at home, who are under medical professionals and pullomany conditions, such as :
medical supervision, in treating many conditions, and enort medical supervision, in themaling trauma and sport Philialy lymphedema, 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)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K.100656