(205 days)
No
The description mentions a "microprocessor controlled pump" but provides no indication of AI or ML capabilities. The intended use and device description are consistent with a standard pneumatic compression device.
Yes
The device is intended to treat medical conditions such as lymphedema and dysfunction of the muscle pump, which are therapeutic applications.
No
The description of the EUREDUC TP03 focuses on therapeutic applications for lymphedema and muscle pump dysfunction, and pre/post-surgical phases, rather than identifying or characterizing a medical condition.
No
The device description explicitly mentions a "pneumatic unit in a plastic casing" with a "microprocessor controlled pump" and "garments connectable to the unit," indicating it includes hardware components.
Based on the provided information, the EUREDUC TP03 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use describes the treatment of conditions like lymphedema and muscle pump dysfunction. This involves applying physical pressure to the body, not analyzing samples taken from the body.
- Device Description: The device is a pneumatic unit with garments that connect to it. This is consistent with a physical therapy or medical device used externally on the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. The EUREDUC TP03's function is to apply external pressure for therapeutic purposes.
N/A
Intended Use / Indications for Use
The EUREDUC TP03 is intended for : - Lymphedema of lower extremities; post surgical or congenital ; - Postmastectomy lymphedema ; - Dysfunction of the muscle pump ; - Pre, post phases of surgery.
Product codes
74JOW
Device Description
EUREDUC TP03 is comprised of: a pneumatic unit in a plastic casing with : - a microprocessor controlled pump; - a control panel a range of garments connectable to the unit: - leg boots; - arm sleeves;
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower extremities, arm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.5800 Compressible limb sleeve.
(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).
0
SEP 2 6 1996
5- 510(k) SUMMARY as required by 807.92 (c)
| Submitter's name | EUREDUC |
|---|---|
| Submitter's address | 35, rue des Broderies 78310 COIGNIERES FRANCE |
| Phone # (33) 1 34 61 01 61 Fax # (33) 1 34 61 40 61 | |
| Name of contact person: | Mr Didier CAUZOT |
| Device Trade name: | EUREDUC TP03 |
| Device common name: | Pneumatic Drainage System |
| Classification name: | Sleeve Limb Compressible 74JOW CFR Section 870 58 00 |
| Predicate device name: | JOBST EXTREMITY PUMP(R) SYSTEM 7500 |
| Predicate device 510(k): | K882683 |
EUREDUC TP03 is comprised of:
a pneumatic unit in a plastic casing with :
- a microprocessor controlled pump;
- a control panel
- a range of garments connectable to the unit:
- leg boots;
- arm sleeves;
The EUREDUC TP03 is intended for :
-
Lymphedema of lower extremities; post surgical or congenital ;
-
Postmastectomy lymphedema ;
-
Dysfunction of the muscle pump ;
-
Pre, post phases of surgery.
... / ...
1
| DEVICE NAME | JOBST EXTREMITY
PUMP (R) | EUREDUC
TP03 |
|--------------------------------|-----------------------------|-----------------|
| DEVICE 510(k) | K8826 83 | NA |
| PRESSURE RANGE | 30 to 100 mm Hg | 15 to 99 mm Hg |
| TREATMENT CYCLE | 200 s | Up to 37 s |
| TREATMENT SESSION | NA | 30 mn |
| POWER | 15 Watts | 24 Watts |
| SLEEVES: No OF
COMPARTMENTS | Up to 3 | Up to 3 |
Compared technical characteristics and performances (from attached labeling)
The EUREDUC TP03 has similare technical characteristics and performances, identical indications and contraindications to the JOBST EXTREMITY PUMP(R).
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