(58 days)
No
The document does not mention AI, ML, or any related concepts like training sets, test sets, or specific algorithms. The performance study focuses on comparison with DEXA and repeatability, not AI/ML model validation.
No
The device is described as a bioimpedance meter used to estimate body fat percentage and is intended for use by normal, healthy people. Its function is for measurement and estimation, not for treating, preventing, or mitigating any disease or condition.
No
The device is a bioimpedance meter used to estimate body fat percentage. While it measures a physiological parameter, its stated purpose is for estimation of body fat, not for diagnosing diseases or conditions. The "Intended Use" explicitly states it's for "normal, healthy people only" and does not mention any diagnostic claims.
No
The device description explicitly states it is a "hand-held, non-sterile, reusable Body Fat Analyzer," indicating it is a physical hardware device, not software only.
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 uses bioimpedance to estimate body fat percentage. It does not analyze samples taken from the body. It measures electrical impedance through the body itself.
- Intended Use: The intended use is to estimate body fat percentage in a home setting for normal, healthy people. This is a general wellness or fitness-related measurement, not a diagnostic test for a disease or condition.
Therefore, the HEALTH & LIFE HL 188 & HL 189 BODY FAT METER falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The HEALTH & LIFE HL 188 & HL 189 BODY FAT METER is intended for estimation of the body fat of percentage in the home.
The device is a noninvasive bioimpedance meter used to estimate body fat percentage in the home setting. The device is for normal, healthy people only, and the applicable age range is 10 to 80 years old.
The device is to be used in a home environment having normal temperature and humidity conditions.
Product codes
74 MNW
Device Description
HEALTH & LIFE HL 188 & HL 189 BODY FAT METER is a hand-held, non-sterile, reusable Body Fat Analyzer intended for estimation of the body fat of percentage in the home.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
10 to 80 years old.
Intended User / Care Setting
Home setting.
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)
In terms of operating specification, Safety & EMC requirements, the device conforms to applicable standards included IEC 60601-1 and IEC 60601-1-2 requirements. Moreover, A comparison study with device that use DEXA(Dual energy X-ray absorptiometry) technology was performed to validate the performance of the HEALTH & LIFE HL 188 & HL 189 BODY FAT METER. Subjects were grouped as male/ female, ages. The comparison study demonstrated that the clinical repeatability of HEALTH & LIFE HL 188 & HL 189 BODY FAT METER is statistically and clinically acceptable in all age/weight/height groups.
bench testing contained in this submission and clinical testing supplied demonstrate that any differences in their technological characteristics do not raise and new questions of safety or effectiveness.
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
§ 870.2770 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.
0
K043414
PAGE 1 OF 2
FEB - 9 2005 510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92
| 1.0 Submitter's Name: | Health & Life Co., Ltd. |
|---|---|
| Address: | 9 F, No. 168, Jian Yi Road, Chung Ho City, Taipei County, Taiwan |
| ZIP code : 235 | |
| Phone: | 886-2-82271300 |
| Fax: | 886-2-82271301 |
| Contact: | Mr. Paul Yang / President |
| 2.0 Device Name: | HEALTH & LIFE HL 188 & HL 189 BODY FAT METER |
| 3.0 Predicate Device: | • LONG WELL LW-6Dxx Body Fat Analyzer (K030203) marketed |
| by LONG WELL ELECTRONICS CORP. & | |
| • Omron HBF-306 Body Fat Analyzer (K011652) marketed by | |
| Omron Healthcare INC. | |
| 4.0 Device Description: | HEALTH & LIFE HL 188 & HL 189 BODY FAT METER is a |
| hand-held, non-sterile, reusable Body Fat Analyzer intended for | |
| estimation of the body fat of percentage in the home. | |
| 5.0 Intended Use: | The HEALTH & LIFE HL 188 & HL 189 BODY FAT METER is |
| intended for estimation of the body fat of percentage in the home. | |
| 6.0 Performance Summary: | In terms of operating specification, Safety & EMC requirements, |
| the device conforms to applicable standards included IEC 60601-1 | |
| and IEC 60601-1-2 requirements. Moreover, A comparison study | |
| with device that use DEXA(Dual energy X-ray absorptiometry) | |
| technology was performed to validate the performance of the | |
| HEALTH & LIFE HL 188 & HL 189 BODY FAT METER. |
Subjects were grouped as male/ female, ages. The comparison
study demonstrated that the clinical repeatability of HEALTH &
LIFE HL 188 & HL 189 BODY FAT METER is statistically and
clinically acceptable in all age/weight/height groups. |
.
1
7. Conclusions:
The HEALTH & LIFE HL 188 & HL 189 BODY FAT METER have the same intended use and similar technological characteristics as LONG WELL LW-6Dxx Body Fat Analyzer (K030203) marketed by LONG WELL ELECTRONICS CORP. and Omron HBF-306 Body Fat Analyzer( K011652 )marketed by Omron Healthcare INC.. Moreover, bench testing contained in this submission and clinical testing supplied demonstrate that any differences in their technological characteristics do not raise and new questions of safety or effectiveness. Thus, the HEALTH & HL 188 & HL 189 BODY FAT METER is substantially equivalent to the predicate devices. LIFE
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three horizontal lines representing its wings. The eagle is positioned to the right of a circular emblem containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
HEALTH & LIFE CO., LTD. c/o Ms. Jennifer Reich Harvest Consulting Corporation 3892 South America West Trail FLAGSTAFF AZ 86001
Re: K043414
Trade/Device Name: HEALTH & LIFE HL 188 & HL 189 BODY FAT METER Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: 74 MNW Dated: December 3, 2004 Received: December 13, 2004
FEB - 9 2005
Dear Ms. Reich:
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.
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); 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.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally prematics notificate device results in a classification for your device 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 11 you atter office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrl/dsmadsmamain.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
4
Indications for Use
510(k) Number (if known): _______K043414
Device Name: HEALTH & LIFE HL 188 & HL 189 BODY FAT METER Health & Life Co., Ltd.
Indications For Use:
The device is a noninvasive bioimpedance meter used to estimate body fat percentage in the home setting. The device is for normal, healthy people only, and the applicable age range is 10 to 80 years old.
The device is to be used in a home environment having normal temperature and humidity conditions.
Prescription Use (Part 21 CFR 801 Subpart D)
510(k) Number
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices 40/12/14
Abdominal.t
Page 1 of 1