JTECH ADJUSTER REFLEX GUN

K974376 · J-Tech Medical, Inc. · LXM · Feb 18, 1998 · PM

Device Facts

• Record ID: K974376
• Device Name: JTECH ADJUSTER REFLEX GUN
• Applicant: J-Tech Medical, Inc.
• Product Code: LXM · PM
• Decision Date: Feb 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended 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.

Device Story

JTECH Adjuster Reflex Gun is a mechanical device used by licensed practitioners (e.g., chiropractors, physical therapists) as an alternative to manual spinal adjustment. Device provides controlled mechanical force to specific anatomical segments, including cervical, thoracic, and lumbar spine, sacrum, ilium, and extremities. Operated by practitioner to deliver stimulation when manual techniques are contraindicated or ineffective. Benefits include providing a consistent, non-manual method for spinal and extremity mobilization/stimulation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical stimulation device; handheld form factor; manual operation; no electronic or software components.

Indications for Use

Indicated for use by licensed practitioners for stimulation of cervical, thoracic, and lumbar spine segments, sacrum, ilium, and extremities when manual adjustment is ineffective, impossible, or undesirable.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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 18 1998

Re: K974376
Trade Name: JTECH Adjuster Reflex Gun
Regulatory Class: Unclassified
Product Code: LXM
Dated: November 19, 1997
Received: November 20, 1997

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 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 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 [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,


Enclosure

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510(k) Number (if known): K974376

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 K974376

(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 ☐