(199 days)
Not Found
No
The description focuses on basic device parameters (pressure, cycle time, gradient) and standard regulatory compliance, with no mention of AI, ML, or related concepts.
Yes
The device is intended for treating conditions such as lymphedema, edema, and venous insufficiencies, which falls under therapeutic use.
No
The device is described as a treatment device for conditions like lymphedema and edema, and it focuses on delivering therapy (variable duration, pressure, cycle time, and gradient setting) rather than identifying or analyzing medical conditions.
No
The device description explicitly mentions a "Power unit" and "four chamber garments," indicating hardware components beyond just software.
Based on the provided information, the LX7(V7) 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 direct physical therapy and treatment of the patient's body.
- Device Description: The description mentions a power unit and four-chamber garments for the leg, used for applying pressure and cycles. This aligns with a physical therapy or compression device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to perform tests on biological samples outside of the body. The LX7(V7) is a therapeutic device that interacts directly with the patient's limb.
N/A
Intended Use / Indications for Use
LX7(V7) 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
IRP
Device Description
LX7(V7) 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
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K102320
Page 1 of 3
MAR - 4 2011
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: DAESUNG MAREF CO LTD Address: 689-31 Gumjung-dong, Gunpo-si Gyeonggi-do 451-864 KOREA
D. Regulatory Information
-
- Classification Name: Massager, Powered Inflatable Tube
-
- Common / Usual Name: Powered Inflatable Tube Massager
-
- Proprietary Name: Compressible Limb Therapy System LX7(V7)
-
- Classification / Product Code: Class II / IRP (21 CFR 890.5650)
E. Intended Use
LX7(V7) 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
LX7(V7) 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
- -- Predicate Device 1
- 510(k) number: K013331
- Name: Lympha Press Plus
- Classification: 2
Predicate Device 2
- 510(k) number: K100656
- Name: Compressible Limb and Circulation Therapy Systems
1
K102320
page 2 of 3
(WHF-324 (POWER-Q1000 PLUS))
2. Comparison with predicate
| Model Name | LX7(V7) | Lympha press plus | WHF-324
(POWER-Q1000 Plus) |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | None yet | K013331 | K100656 |
| Classification | Class II Device / IRP (21
CFR 890.5650) | Class II Device / JOW (21
CFR 870.5800) | Class II Device / IRP (21
CFR 890.5650) |
| Intended Use | LX7(V7) 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. | Treatment of Lymphatic
disorders, Venous disorder,
Post-mastectomy
Lymphedema and
Dysfunction of the Muscle
Pump. | The WHF-324 (POWER
Q1000 Plus) 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. |
| Standard | EN ISO 14971
EN 60601-1
EN 60601-2-10
EN 60601-1-2 | EN ISO 14971
EN 60601-1
EN 60601-2-10
EN 60601-1-2 | EN ISO 14971
EN 60601-1
EN 60601-2-10
EN 60601-1-2 |
| Indications | Primary lymphedema,
Edema following trauma
and sport injuries,
Postimmobilization
edema,
Venous insufficiencies,
Lymphedema. | - | Primary lymphedema,
Edema following trauma
and sport injuries,
Post immobilization edema,
Venous insufficiencies,
Lymphedema. |
| Mode of
Compression | Sequential | Sequential | Sequential |
| Mode description | 2 modes | 2 modes
(Lympha, Gradient12,
Wave, Ballancer, and
Pre-Therapy) | 1 mode |
| Power Source | Electricity Supply:
230 V~,50/60 Hz
Electricity
consumption: ,35W | Electricity Supply:
230 V~,50/60 Hz | Electricity Supply:
220~240V 50/60Hz
consumption: 25 watts |
| Therapy Time | 0-30 minutes | 0-10 minutes | 0-30 minutes |
| Maximum and
Minimum
Pressure | 0-230mmHg | 0-200mmHg | 0-235mmHg |
| Number of
Chambers | 4 to 8 chamber | 12 chamber | 4 to 8 chamber |
| Compression
Cycle Time | 30min | 30 min | 30min |
| Garments Sleeve
Material | Nylon | - | Nylon |
- Conclusion
2
K102320
page 3 of 3
Compressible Limb Therapy System (LX7(V7)) has substantial equivalent intended use as the-market-cleared WHF-324 (POWER-Q1000 Plus) and has substantial equivalent technological and performance characteristics with Lympha Press plus .
After analyzing both bench as well as laboratory testing to applicable standards, it is the conclusion of Compressible Limb Therapy System (LX7(V7)) 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)
- LX7(V7)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, 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
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Daesung Maref Co., Ltd. % PATS Corporation Mr. Brandon Choi 205 S. Broadway, Suite 718 Los Angeles, CA 90012
MAR - 4 2011
Re: K102320
Trade/Device Name: Compressible Limb Therapy System LX7(V7) Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: February 25, 2011 Received: March 1, 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) 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
4
Page 2 - Mr. Brandon Choi
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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Aling B. R. Ja.
Mark N. Melkerson Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): | | | | | 2 3 2 2
Device Name: Compressible Limb Therapy System LX7(V7)
Indications For Use: LX7(V7) 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.
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)
Sign-Off
(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102320