(467 days)
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No
The summary describes a system that collects physical fitness measurements using standard sensors and a computer interface, with no mention of AI or ML in the device description, intended use, or specific sections for AI/ML mentions.
No
The device is described as a "physical fitness assessment device" used to "test and to measure... medical fitness levels." It measures various fitness parameters but does not provide therapy or treatment.
No
The device is described as a "physical fitness assessment device" that measures "medical fitness levels" through metrics like body weight, strength, flexibility, body fat, and heart rate. It is intended for testing and measuring fitness levels, not for diagnosing diseases or medical conditions.
No
The device description explicitly lists multiple hardware components (computer, scale, strength handle, flexibility tester, caliper, heart rate monitor, interface box) that are part of the system.
Based on the provided information, the TriFIT 700M is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- TriFIT 700M Function: The TriFIT 700M assesses physical fitness through direct measurements of the body (weight, strength, flexibility, skin-fold thickness, heart rate). It does not analyze biological samples taken from the body.
- Device Components: The components listed (weight scale, strength handle, flexibility tester, skin-fold caliper, heart rate monitor) are all designed for direct physical measurements, not for analyzing biological specimens.
Therefore, the TriFIT 700M falls under the category of a physical fitness assessment device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The TriFIT 700M is a physical fitness assessment device which can be used in both professional environments and at home for individuals to test and to measure their physical fitness levels. The assessment includes body weight, biceps strength, flexibility, skin-fold thickness (to estimate percentage body fat), and heart rate.
Product codes
DRT
Device Description
The TriFIT 700M consists of the following components:
-
- A standard desktop computer to include the monitor, keyboard, mouse, and printer
- Platform weight scale 2.
-
- Strength measuring handle
-
- Flexibility tester
-
- Skin-fold caliper
-
- Heart rate monitor
These components all attach to an interface box. This interface box attaches to the computer via a serial cable. Some components are optional.
- Heart rate monitor
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
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Indicated Patient Age Range
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Intended User / Care Setting
professional environments and at home
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.)
Not Found
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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§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
0
MAR 1 - 2005 KO336 46 Polar HealthFirst
510(k) Summary
Applicant: Polar HealthFirst Corporation 9600 San Mateo Blvd N.E. Albuquerque, New Mexico 87113 Phone (505) 344-1400 Fax (505) 344-1200
Point of Contact: Mr. Jay Skolnik, P.E.
Prepared By: Skolnik Engineering 1317-B Central Avenue S.E., Suite 115 Albuquerque, New Mexico 87123-5549 Phone (505) 299-1157 Fax (505) 299-3647
Date Prepared: December 23, 2004
Trade Name: TriFIT 700M
Common Name: Physical Fitness Assessment System
Classification Name: Computer, Diagnostic, Pre-Programmed, Single-Function
Equivalent Legally Marketed Device: TriFIT 700M is similar in function to the Microfit fitness evaluation system made by Microfit, Inc. in Mountain View, CA.
Description of Device: The TriFIT 700M consists of the following components:
-
- A standard desktop computer to include the monitor, keyboard, mouse, and printer
- Platform weight scale 2.
-
- Strength measuring handle
-
- Flexibility tester
-
- Skin-fold caliper
-
- Heart rate monitor
1
These components all attach to an interface box. This interface box attaches to the computer via a serial cable. Some components are optional.
Intended Use: The TriFIT 700M is used to measure an individual's physical fitness level. Measurements include body weight, biceps strength, flexibility, skin-fold thickness (to estimate percentage body fat), and heart rate.
Technological Characteristics: The TriFIT 700M is substantially equivalent to the recentorogical Characteristics.
Microfit Fitness Evaluation Systems are both operated by a PC, and consist of a bike and ancillary components for measurements that are basically identical.
| Comparison Table | ||
|---|---|---|
| Microfit | TriFIT 700M | |
| Intended Use | ||
| Physical fitness assessment device to be used on apparently healthy population | * | * |
| Interactive Assessments | ||
| Body Weight | * | * |
| Biceps Strength | * | * |
| Sit and Reach Flexibility Test | * | * |
| Skin-fold Calipers for Body Composition | * | * |
| Bike with Heart Rate Receiver and RPM pickup | * | * |
| Data Entry/Software | ||
| Demographic Information (address, phone, email, etc.) | * | * |
| Health Risk Questionnaires | * | * |
| Fields tests-manual keyboard entry | * | * |
| Exercise Programming | * | * |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
MAR 1 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Polar HealthFirst Corporation c/o Mr. Jay Skolnik, PE Skolnik Engineering 13170-B Central Ave. SE Suite 115 Albuquerque, NM 87123
K033646 Re: Trade Name: TriFIT 700M Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate and alarm) Regulatory Class: II (two) Product Code: DRT Dated: December 23, 2004 Received: December 27, 2004
Dear Mr. Skolnik:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your bector of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encrosure) to regard) the enactment date of the Medical Device Amendments, or to conniner that have been reclassified in accordance with the provisions of the Federal Food, Drug, devices that have been resulted in ause approval of a premarket approval application (PMA). alle Cosment Act (Act) that do not require the general controls provisions of the Act. The r ou may, mercroro, market of the Act include requirements for annual registration, listing of general exhilitions providers of abeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your device is etablifiedal controls. Existing major regulations affecting your device it may or subject to bach additions, Title 21, Parts 800 to 898. In addition, FDA ean be found in the over ents concerning your device in the Federal Register
3
Page 2 - Mr. Jay Skolnik, PE
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualles of a substainter open ies with other requirements of the Act that FDA has made a decemination administered by other Federal agencies. You must a or any Federal Statutes and regulations daministered or registration and listing (21 comply with an the Act s requirements, mo; good manufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 820); and 1f applicable, the electronic iorul in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Deceible over device as described in your Section 510(k) I his letter will anow you to begin manceing your as revivalence of your device to a legally premarket notification. "The PDT Imaxing of cation 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 If you desire specific advice for your ac not an each of each and of the regulation entitled, colliact the Office of Complance at (176) = 16 = 21 = 21 807.97). You may obtain "Misoranding by refected to premainter notifical with the Act from the Division of Small other gelleral Information on your response Assistance at its toll-free number (800) 638-204) or Manufacturers, Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Brimmer for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(K) Number (if known): K033646
Device Name: TriFIT 700M
Indications For Use:
The TriFIT 700M is a physical fitness assessment device which can be used in both The THFTF 700M IS a physical Inness assess for individuals to test and to measure their medical fitness levels. The assessment includes body weight, biceps strength, flexibility, phySical Intriess foven. "It estimate percentage body fat), and heart rate.
Prescription Use: No (Parl 21 CFR 801 Subpart D)
And/Or
Over-The-Counter Use: Yes (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)
B. Bammma
(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number -
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