(146 days)
Not Found
No
The summary describes a pneumatic compression device with adjustable settings, but there is no mention of AI, ML, or any learning or adaptive capabilities.
Yes.
The device is intended for use in treating various medical conditions such as lymphedema, edema, and venous insufficiencies, indicating its therapeutic purpose.
No
The device description and intended use indicate it is used for treating conditions like lymphedema and edema, not for identifying or diagnosing them. It is a therapy device (e.g., compressible limb therapy system).
No
The device description explicitly mentions a "Power unit" and "four chamber garments," which are hardware components. The summary also references standards related to electrical safety (IEC 60601-1, IEC 60601-1-2), further indicating a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes treating conditions like lymphedema and edema. This involves applying physical therapy (compression) to the body.
- Device Description: The device description talks about a power unit and four-chamber garments for the leg, used for applying pressure and cycles. This is a physical therapy device.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are used to examine specimens in vitro (outside the body) to provide information about a person's health.
This device is a therapeutic medical device, specifically a pneumatic compression device used for physical therapy.
N/A
Intended Use / Indications for Use
MK300L 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
MK300L 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
full 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)
MK300L 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 60601-1-2, 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
510(K) SUMMARY
[as required by 807.92(c)]
JAN 1 7 2012
A. 510k Number:
B. Applicant:
Company name: PATS CORP Address: 205 S Broadway, Suite 718, Los Angeles California 90012 USA Contact person: Daniel Nam Phone: 213-626-1544
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 MK300L
-
- Classification / Product Code: Class II / IRP (21 CFR 890.5650)
E. Intended Use
MK300L 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
MK300L 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: K012320
- Name: LX-7
- Classification: 2
Predicate Device 3
- 510(k) number: K102319
- Name: WIC-2008
1
-
Classification: 2
-
- Comparison with predicate
Compressible Limb Therapy System MK300L has substantial equivalent intended use as the-market-cleared LX-7 and has substantial equivalent technological and performance characteristics with Lympha press plus and WIC-2008.After analyzing both bench as well as laboratory testing to applicable standards, it is the conclusion of Compressible Limb Therapy System MK300L 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.
- Comparison with predicate
Consequently, it is clear that it substantially equivalent to the predicate devices.
-
H. Performance Characteristics (If/when applicable)
MK300L 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 60601-1-2, 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 logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three overlapping wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
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. Daniel Nam 205 South Broadway, Suite 718 Los Angeles, California 90012
JAN 1 7 2012
Re: K112441
Trade/Device Name: Compressible Limb Therapy System MK300L Regulation Number: 21 CFR 890.5650 Regulation Name: Powered inflatable tube massager Regulatory Class: Class II Product Code IRP Dated: December 5, 2011 Received: December 9, 2011
Dear Mr. Nam:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becaused 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 conimeree prof to riay =classified in accordance with the provisions of the Federal Food, devices that have been totact) that do not require approval of a premarket approval application Drag, and obsince, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual the ree." The general conneces, good manufacturing practice, labeling, and prohibitions against regiountion, maning or arrange: 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 your device to additional controls. Existing major regulations affecting your device can it may be subject to additions, 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 I teast be actived that FDT I o teamination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You the ret of the Act's requirements, including, but not limited to: registration and linest comply with an the riot of the eart 801); medical device reporting (reporting of
3
Page 2 -- Mr. Daniel Nam
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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Indications for Use
510(k) Number (if known):
Device Name: Compressible Limb Therapy System MK300L
Indications For Use: MK300L 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.
X ____________________________________________________________________________________________________________________________________________________________________________ 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)
Yung D. Luth
gn-Off) (Diylsion (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112441