DEVICE: Echolight S.p.a. (08052461860091)
Device Identifier (DI) Information
Device Characteristics
| Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 36022 | Bioelectrical body composition analyser |
An electronic device designed to estimate body composition (i.e., percent body fat, lean, bone, and/or hydration) with regards to bioelectrical impedance analysis (BIA) and often personal characteristics (e.g., age, gender, height, weight). It may be in the form of a unit with electrodes applied to the surface of the patient’s body, or a scale(s) placed on the floor and upon which the patient stands to measure total body weight. Both types perform BIA by passing a low electrical current through the body; personal characteristics may be manually entered. Data are analysed to provide measurements that may include body mass index (BMI), fat/muscle/bone mass, and total body water percent.
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Active | false |
| 40779 | Bone absorptiometric ultrasound system |
An assembly of devices used to produce bone density measurements and other calculations based on data obtained from transmitted and reflected ultrasound (US) waves. Also called a bone densitometer, it has an integrated ultrasound transducer to deliver an ultrasound beam to an anatomical region of interest. Information obtained from detection and analysis of resulting echoes is used in calculations to estimate bone mineral density or subcutaneous fat, or to make other quantitative assessments (e.g., fracture risk). It typically incorporates an ultrasound transducer, detection electronics, a control panel, a computer, software programs, a video display, and a patient positioning system (PPS).
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Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| MUA | Bone Sonometer |
| OMV | Ultrasonic Body Composition Analyzer |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K202514 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
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| No storage/handling found |
Clinically Relevant Size
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| No Device Sizes |
Device Record Status
95d38485-b273-4889-910b-01786dcbd3a6
April 17, 2025
1
April 09, 2025
April 17, 2025
1
April 09, 2025
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Secondary DI
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|---|---|
| No Secondary DIs found | |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined