(289 days)
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No
The summary describes a standard bioelectrical impedance scale with results displayed on an LCD panel. There is no mention of AI, ML, or any complex data processing beyond basic calculations of body fat percentage and BMI.
No.
The device measures body weight, impedance, body fat percentage, and BMI, which are diagnostic or monitoring functions, not therapeutic. It does not treat or alleviate any medical condition.
No
The device measures body weight, impedance, fat percentage, and BMI, which are general health metrics rather than diagnostic indicators of a specific disease or condition. Its intended use is for "normal subjects" and it does not claim to diagnose any medical conditions.
No
The description explicitly states the device measures body weight and impedance using Bioelectrical Impedance and displays results on an LCD panel, indicating the presence of hardware components beyond just software.
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 Function: This device measures body weight and impedance using Bioelectrical Impedance Analysis (BIA). It calculates body fat percentage and BMI based on these measurements.
- Lack of Sample Analysis: The device does not analyze any samples taken from the body. It interacts with the body externally to take measurements.
Therefore, while it provides health-related information, it does not fit the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The device measures body weight, and impedance using Bioelectrical Impedance The uevice measures body worgin, and cally fat percentage, BMI, with results displayed in LCD panel.
The intended use of this device is for 7 to 99 years old normal subjects and not for I he intended use of ans econmended personal with implanted internal device like pacemaker or pregnant women to use this device.
Product codes
74 MNW
Device Description
Oregon Scientific High Precision Body Weight Monitor with Body Fat Index Model: GA101
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
Not Found
Indicated Patient Age Range
7 to 99 years old
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
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Key Metrics
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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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§ 870.2770 Impedance plethysmograph.
(a)
Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.(b)
Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is a symbol of medicine and health. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
'JAN 2 8 2004
Mr. Stephen Li Vice President - Health Care Products IDT Technology Limited Block C, 9/F., Kaiser Estate Phase 1, 41 Man Yue Street Hunghom, Hong Kong, CHINA
Re: K031167
Trade/Device Name: Oregon Scientific High Precision Body Weight Monitor with Body Fat Index, Model GA101 Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: 74 MNW Dated: December 1, 2003 Received: December 10, 2003
Dear Dr. Li:
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 for answer a may 28, 1976, the enactment date of the Medical Device Amendments, or to oonimer of the rest to rial 2011 de noos that have been 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 I ou may, ato.es or visions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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 r tease be as 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 or any with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.
1
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin marketing for articlequivalence of your device to a legally premarket notification. The FDA inting or saccuman equivalias and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your device on our line following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on the promotion and and one the regulation entitled, "Mistranding Office of Compliance at (501) 554-1057. This, processor. The Division of Small by reference to premarket notification (21 CF CF Cr In C From the Division of Staall
information on your responsibilities under the Act the first from the (800) 638-2041 information on your responsibilities under Assistance at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-free decreenc Manufacturers, International and Collsums: 126.0001.10.10.2007/00/01/dsma/dsmamain.html.
(301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon.
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): 5031167
Device Name: Oregon Scientific High Precision Body Weight Monitor with Body Fat Index Model: GA101
Indications for Use:
The device measures body weight, and impedance using Bioelectrical Impedance The uevice measures body worgin, and cally fat percentage, BMI, with results displayed in LCD panel.
The intended use of this device is for 7 to 99 years old normal subjects and not for I he intended use of ans econmended personal with implanted internal device like pacemaker or pregnant women to use this device.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurence of CDRH, Office of Device Evaulation (ODE)
Prescription Use______________________________________________________________________________________________________________________________________________________________
OR
Over-the-Counter Use
David K. Lyonn
(Optional Format 3-10-98)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K031167