QUINTON MEDTRACK CR PLUS TREADMILL

K990866 · Quinton, Inc. · ISD · Apr 29, 1999 · Physical Medicine

Device Facts

• Record ID: K990866
• Device Name: QUINTON MEDTRACK CR PLUS TREADMILL
• Applicant: Quinton, Inc.
• Product Code: ISD · Physical Medicine
• Decision Date: Apr 29, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5360
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Quinton MedTrack CR Plus Treadmill is intended to be used as a rehabilitation device for cardiovascular conditioning. The intended population are ambulatory patients undergoing exercise rehabilitation.

Device Story

MedTrack CR Plus Treadmill functions as rehabilitation device for cardiovascular conditioning. Device provides motorized surface for patient ambulation during exercise therapy. Operated by clinicians in clinical settings to facilitate patient physical activity. Output consists of mechanical movement of treadmill belt, controlled by clinician to adjust speed and incline. Clinical benefit derived from controlled cardiovascular conditioning of ambulatory patients. Device does not incorporate complex software or automated diagnostic algorithms.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Motorized treadmill for cardiovascular rehabilitation. Mechanical design; no complex electronic sensing or software-based diagnostic algorithms described. Standard electrical energy source for motor operation.

Indications for Use

Indicated for ambulatory patients undergoing cardiovascular exercise rehabilitation.

Regulatory Classification

Identification

Measuring exercise equipment consist of manual devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. These devices also include instrumentation, such as the pulse rate monitor, that provide information used for physical evaluation and physical planning purposes., Examples include a therapeutic exercise bicycle with measuring instrumentation, a manually propelled treadmill with measuring instrumentation, and a rowing machine with measuring instrumentation.

Special Controls

*Classification.* Class II (special controls). The device, when it is a measuring exerciser or an interactive rehabilitation exercise device for prescription use only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 9 1999

Mr. Matthew J. Hedlund Manager, Regulatory Affairs Quinton Instrument Corporation 3303 Monte Villa Parkway Bothell, Washington 98021-8906

Re: K990866 Quinton MedTRack CR Plus Treadmill Trade Name: Requlatory Class: II Product Code: ISD Dated: March 15, 1999 Received: March 16, 1999

Dear Mr. Hedlund:

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 requirement, 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 In addition, FDA may publish further announcements action. 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. Matthew J. Hedlund

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,

Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and

Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: MedTrack CR Plus Treadmill

Indications for Use:

:

The Quinton MedTrack CR Plus Treadmill is intended to be used as a rehabilitation device for cardiovascular conditioning. The intended population are ambulatory patients undergoing exercise rehabilitation.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| Division of General Restorative Devices | |
| 510(k) Number | K990866 |

Prescription Use _____________________________________________________________________________________________________________________________________________________________

OR

Over-The-Counter Use

(Optional Format 1-2-96)

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