(75 days)
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No
The description details a purely mechanical, inflatable device with no mention of computational processing, algorithms, or learning capabilities.
Yes
Explanation: The device description clearly states "The patient repeats this process until the therapy session is completed," indicating its use for therapeutic purposes. Additionally, the predicate device is an "Intermittent Compression System," which also points towards a therapeutic function.
No
Explanation: The device description indicates it is an "inflatable garment or boot" used for therapy, and the predicate device is an "Intermittent Compression System", which suggests a therapeutic rather than diagnostic function. There is no mention of measurement, analysis, or detection of any medical conditions.
No
The device description clearly describes a physical, inflatable garment (boot) with chambers, air passageways, a hand pump, and a valve. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that this device is an inflatable garment or boot used on a patient's lower limbs. It involves mechanical action (inflation and deflation) and is applied externally to the body.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting biomarkers, or any other activity typically associated with in vitro diagnostics.
Therefore, this device falls under the category of a medical device, but not an IVD.
N/A
Intended Use / Indications for Use
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Product codes (comma separated list FDA assigned to the subject device)
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Device Description
This device is an inflatable garment or boot that is intended for use on patients' lower limbs. It consists of two chambers. The upper chamber envelopes the lower extremity and the lower chamber is located under the foot.
When pressure is applied to the lower chamber by the patient's foot, air moves from the lower chamber to the upper chamber through the air passageways shaded in blue. The boot is placed on the patient and then inflated by attaching a hand pump to the port at the top of the boot. The boot is inflated to the desired pressure
The patient repeats this process until the therapy session is completed. To deflate the boot, the patient presses inward on the valve stem with his/her finger or uses the cap that is attached to the valve. The deflated boot is then easily removed.
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
lower limbs
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): 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.
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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).
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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).
0
Ka64957
FEB 2 4 1997
EISCHCO, Inc. EISCHCO Inflatable Massager Boot Premarket Notification Summary
Device Description: ડ.
This device is an inflatable garment or boot that is intended for use on patients' lower limbs. It consists of two chambers. The upper chamber envelopes the lower extremity and the lower chamber is located under the foot.
When pressure is applied to the lower chamber by the patient's foot, air moves from the lower chamber to the upper chamber through the air passageways shaded in blue. The boot is placed on the patient and then inflated by attaching a hand pump to the port at the top of the boot. The boot is inflated to the desired pressure
The patient repeats this process until the therapy session is completed. To deflate the boot, the patient presses inward on the valve stem with his/her finger or uses the cap that is attached to the valve. The deflated boot is then easily removed.
Substantial Equivalency Comparisons: 6.
EISCHCO's Inflatable Massager Boot is substantially equivalent to Chattanooga Group's. Inc. Intermittent Compression System K832920. A companson of EISCHCO's Inflatable Massager Boot and the predicate device in Table I shows that both devices are the same except for the method for inflating the garment
The EISCHCO boot provides intermittent pressure to the garment by manual means, i.e. by actual exercise by the wearer. Pressing against a floor, wall, footboard of a bed, or possibly the foot rest of a wheelchair causes air to pass through the lower chamber to the upper chamber. As a result, pressure increases in the upper chamber and to the patient's limbs. The predicate device provides intermittent pressure to the garment by the presssion pump.
7. Conclusion:
The EISCHCO Inflatable Massager Boot is substantially equivalent to Chattanooga Group's, Inc. Intermittent Compression System K832920