TRIFIT 700

K033646 · Healthfirst Corp. · DRT · Mar 1, 2005 · Cardiovascular

Device Facts

• Record ID: K033646
• Device Name: TRIFIT 700
• Applicant: Healthfirst Corp.
• Product Code: DRT · Cardiovascular
• Decision Date: Mar 1, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2

Indications for Use

The TriFIT 700M is a physical fitness assessment device which can be used in both clinical and non-clinical settings 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.

Device Story

TriFIT 700M is a physical fitness assessment system. Inputs include body weight (via platform scale), biceps strength (via handle), flexibility (via tester), skin-fold thickness (via caliper), and heart rate (via monitor). Components connect to an interface box, which links to a standard desktop PC via serial cable. Software processes these inputs to provide fitness evaluations, health risk questionnaires, and exercise programming. Used in clinical or non-clinical settings by fitness professionals or individuals. Output allows healthcare providers or users to assess fitness levels and track progress, facilitating personalized exercise planning.

Clinical Evidence

No clinical data provided. The submission relies on bench testing and comparison of technological characteristics to the predicate device.

Technological Characteristics

System consists of a standard desktop PC, platform weight scale, strength measuring handle, flexibility tester, skin-fold caliper, and heart rate monitor. Components connect to an interface box linked to the PC via serial cable. Operates as a diagnostic, pre-programmed, single-function computer system.

Indications for Use

Indicated for individuals seeking to measure physical fitness levels, including body weight, biceps strength, flexibility, body fat percentage via skin-fold thickness, and heart rate. Suitable for use in clinical and non-clinical settings.

Regulatory Classification

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.

Predicate Devices

• Microfit fitness evaluation system (K033646)

Submission Summary (Full Text)

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## 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 [phone] Fax [phone]

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 [phone] Fax [phone]

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:

- 1. A standard desktop computer to include the monitor, keyboard, mouse, and printer
- Platform weight scale 2.
- 3. Strength measuring handle
- 4. Flexibility tester
- 5. Skin-fold caliper
- 6. Heart rate monitor

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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 | * | * |

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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

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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

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# 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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