(90 days)
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Not Found
No
The summary describes a mechanical adjustment device and contains no mention of AI, ML, or related concepts like image processing or data sets.
Yes
The device is described as being used for "stimulating segments" of the spine and extremities, which implies a direct therapeutic intervention rather than just diagnosis or information gathering. Its use is also indicated "when the practitioner deems manual adjustment not to be effective, possible or desirable," further suggesting it's an alternative therapeutic tool.
No
Explanation: The device is described as an "Adjuster Reflex Gun" used for stimulating segments of the spine and extremities. Its intended use focuses on providing manual adjustment alternatives rather than diagnosing medical conditions. There is no mention of it collecting data, analyzing patient conditions, or providing diagnostic information.
No
The device description "JTECH Adjuster Reflex Gun" and the intended use describing its application for stimulating segments of the spine and extremities strongly suggest a physical device, not software.
Based on the provided information, the JTECH Adjuster Reflex Gun is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description states the device is a "Reflex Gun" used for "stimulating segments of the cervical spine, thoracic spine and lumbar spine as well as the sacrum, ilium and extremities." This indicates a physical manipulation or stimulation device, not a test performed on a biological sample.
- Intended Use: The intended use describes a physical adjustment method, not a diagnostic test.
Therefore, the JTECH Adjuster Reflex Gun falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The JTECH Adjuster Reflex Gun is designed to be used when the practitioner deems manual adjustment not to be effective, possible or desirable. It can be used for stimulating segments of the cervical spine, thoracic spine and lumbar spine as well as the sacrum, ilium and extremities.
Product codes
LXM
Device Description
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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
cervical spine, thoracic spine, lumbar spine, sacrum, ilium, extremities.
Indicated Patient Age Range
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Intended User / Care Setting
licensed practitioner
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.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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N/A
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of three human figures in profile, arranged in a cascading manner. The figures are enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" encircling the figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JTECH Medical Industries, Inc. c/o Mr. E.J. Smith Smith Associates P.O. Box 4341 Crofton, Maryland 21114
FEB 1 8 1998
Re : K974376 Trade Name: JTECH Adjuster Reflex Gun Requlatory Class: Unclassified Product Code: LXM Dated: November 19, 1997 November 20, 1997 Received:
Dear Mr. Smith:
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 Regulation (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 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. E.J. Smith
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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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: JTECH Adjuster Reflex Gun
Classification Panel: Physical Medicine LXM
Indications for Use:
The JTECH Adjuster Reflex Gun is designed to be used when the practitioner deems manual adjustment not to be effective, possible or desirable. It can be used for stimulating segments of the cervical spine, thoracic spine and lumbar spine as well as the sacrum, ilium and extremities.
Warning: Federal (U.S.A.) law restricts this device to sale by or on the order of a licensed practitioner.
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K9 7 4
Devices
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
× Prescription Use
or
Over-the-Counter Use