JTECH COMMANDER AND ALGOMETER

K971407 · J-Tech Medical, Inc. · HRW · Apr 20, 1998 · Orthopedic

Device Facts

• Record ID: K971407
• Device Name: JTECH COMMANDER AND ALGOMETER
• Applicant: J-Tech Medical, Inc.
• Product Code: HRW · Orthopedic
• Decision Date: Apr 20, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1250
• Device Class: Class 1

Intended Use

The JTECH Commander Algometer is a calibrated pressure or force stimulus device. It measures the soft tissue response for pain tolerance, pain threshold and trigger point tenderness. It is also used to screen for finger strength.

Device Story

JTECH Commander Algometer is a calibrated pressure/force stimulus device; measures soft tissue response for pain threshold, pain tolerance, and trigger point tenderness; also used for finger strength screening. Device provides objective quantification of pressure-related pain metrics; used by clinicians to assess musculoskeletal conditions. Output allows healthcare providers to monitor patient progress and evaluate treatment efficacy. Device operates as a handheld diagnostic tool.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Calibrated pressure/force stimulus device. Handheld form factor. Operates as a diagnostic measurement tool for physical assessment.

Indications for Use

Indicated for measuring soft tissue response to determine pain tolerance, pain threshold, and trigger point tenderness, and for screening finger strength.

Regulatory Classification

Identification

A nonpowered dynamometer is a mechanical device intended for medical purposes to measure the pinch and grip muscle strength of a patient's hand.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 20 1330

Mr. Tracy Livingston Senior Vice President JTech Medical Industries 357 West 910 South Heber City, Utah 84032

Re: K971407 JTECH Commander and Algometer Trade Name: Regulatory Class: II Product Code: HRW Dated: January 12, 1998 Received: January 20, 1998

## Dear Mr. Livingston:

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 The general controls provisions of the Act 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 Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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. Livingston

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): K971407

Device Name: JTECH Commander™ Algometer

Classification Panel: BSI

Indications for Use:

The JTECH Commander Algometer is a calibrated pressure or force stimulus device. It measures I he 51 LC1 Conninential response for pain tolerance, pain tolerance, pain threshold and trigger point tenderness. It is also used to screen for finger strength.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div> <svg height="16" width="16"> <path d="M4.4 9.4l1.5 1.5 5-5" fill="none" stroke="#000"></path> </svg> </div> |
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| or | Over-The-Counter Use |

(Division Sign-Off)

Division of General Restorative Devices

| 510(k) Number | k971407 |
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