HEART PROTECTOR (VER 1996)

K965158 · N.P.N.T., Inc. · DRT · Dec 9, 1997 · Cardiovascular

Device Facts

• Record ID: K965158
• Device Name: HEART PROTECTOR (VER 1996)
• Applicant: N.P.N.T., Inc.
• Product Code: DRT · Cardiovascular
• Decision Date: Dec 9, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2

Indications for Use

To be used before, during and after exercise. To be used while at rest. The primary function is as a Heart Tachometer. The user also can be alerted if various presets have been exceeded.

Device Story

Heart Protector functions as a heart tachometer for monitoring heart rate during rest and exercise. Device captures heart rate signals; processes data to display current heart rate; compares input against user-defined presets. Alerts user if heart rate exceeds thresholds. Intended for use by individuals to track cardiac activity. Output provides real-time heart rate feedback to assist users in monitoring physiological response to physical activity or rest.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Heart tachometer; electronic signal processing for heart rate detection; user-configurable threshold alerts; form factor suitable for personal use.

Indications for Use

Indicated for individuals requiring heart rate monitoring during rest and exercise; provides heart rate data and alerts when user-defined heart rate thresholds are exceeded.

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Rockville MD 20857
DEC - 9 1997

Mr. Ken Nusbaum
N.P.N.T., Inc.
111 Martin Ross Avenue, Unit 4
Downsview, Ontario
Canada, M3J-2M1

Re: K965158
Heart Protector
Regulatory Class: II (two)
Product Code: 74 DRT
Dated: October 14, 1997
Received: November 19, 1997

Dear Mr. Nusbaum:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Ken Nusbaum

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahan, Ph.D.
Director
Division of Cardiovascular,
Respiratory, and Neurological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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FROM: CRIMP CIRCUITS
FAX NO.: 416 665 0655
10-10-97 12:46 P.02

510(k) Number (if known): K-965158
Device Name: Heart Protector

Indications For Use:

To be used before, during and after exercise. To be used while at rest. The primary function is as a Heart Tachometer. The user also can be alerted if various presets have been exceeded.

(PLEASE DO NOT WRITE BELOW THIS-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number

Prescription Disc: ☑ OR Over The Counter Use:
(Per 21 CFR 801:1091
(Optional Format 1-2-96)

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