(111 days)
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No
The summary describes a pneumatic massage system with no mention of AI or ML capabilities, data processing, or performance studies related to algorithmic analysis.
No
The device is indicated for temporary relief of minor muscle aches and pains and temporary increase of circulation, which are symptomatic relief and not therapeutic.
No
Explanation: The device description and intended use indicate that the Ballancer 505 is a pneumatic massage system used for temporary relief and circulation, not for diagnosing medical conditions.
No
The device description explicitly states it is a "pneumatic massage system" and mentions an "inflatable garment," indicating it includes hardware components beyond just software.
Based on the provided information, the Ballancer 505 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Ballancer 505 Function: The description clearly states the Ballancer 505 is a "pneumatic massage system" that applies "gradient pressure" to the body using an inflatable garment. Its intended uses are related to physical manipulation of tissues and temporary effects on circulation and muscle aches.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens.
Therefore, the Ballancer 505 falls under the category of a physical therapy or massage device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Ballancer 505 is a pneumatic massage system intended to provide gradient pressure in areas, which the inflatable garment is applied.
The Ballancer 505 System is indicated for:
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Simulating kneading and stroking of the tissues by use of an inflatable garment
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Temporary increase circulation in areas which the garment is applied
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Temporary relief of minor muscle aches and pains
Product codes
IRP
Device Description
Ballancer 505 is a pneumatic massage system
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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Image /page/0/Picture/1 description: The image shows a black and white logo. The logo features the Department of Health & Human Services seal on the left side. To the right of the seal, the letters 'DEP' are written in bold, sans-serif font, with a horizontal line underneath.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 26, 2015
Mego Afek AC Ltd. Mrs. Liat Winter OA and RA Manager Kibbutz Afek, 3004200 Israel
Re: K150269
Trade Name: Ballancer® 505 System, Model 1201-AC Regulation Number: 21 CFR 890.5650 Regulation Name: Powered inflatable tube massager Regulatory Class: Class II Product Code: IRP Dated: April 20, 2015 Received: April 23, 2015
Dear Mrs. Winter:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,
Felipe Aquel -S
Carlos L. Peña. PhD. MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Ballancer 505 System, Model 1201-AC
Indications for Use (Describe)
Ballancer 505 is a pneumatic massage system intended to provide gradient pressure in areas, which the inflatable garment is applied.
The Ballancer 505 System is indicated for:
-
Simulating kneading and stroking of the tissues by use of an inflatable garment
-
Temporary increase circulation in areas which the garment is applied
-
Temporary relief of minor muscle aches and pains
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
× Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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