(110 days)
No
The description focuses on mechanical traction and control of infrared devices, with no mention of AI or ML algorithms for diagnosis, treatment planning, or device control.
Yes
The device is designed to provide therapeutic effects such as relieving low back pain, decompressing intervertebral discs, and through its console function, controlling infrared therapy devices for temporary relief of muscle and joint aches, pains, and stiffness.
No
The device is described as providing traction forces to relieve pain and functioning as a system console for controlling infrared therapy devices. It provides feedback on force applied and angle, but those are measures of the device's output, not diagnostic information about the patient. There is no mention of the device gathering information about the patient's condition for diagnostic purposes.
No
The device description explicitly lists hardware components such as a system console with an electric motor and control electronics, a pull-head/goniometer, and accessories like traction belts. It also controls external infrared therapy devices.
No, the Dynatron DX2 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. This includes things like blood, urine, tissue, etc., to provide information about a person's health.
- The Dynatron DX2 is a physical therapy device. Its intended use is to apply mechanical forces (traction) to the low back to relieve pain and discomfort. It also controls infrared therapy devices which apply heat externally.
The description clearly states its function is to provide "static, intermittent, and cycling distraction forces" and control "infrared therapy devices." These are all external applications to the body, not the analysis of internal specimens.
N/A
Intended Use / Indications for Use
The Dynatron DX2 is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back pain. It relieves pain associated with hemiated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.
The Dynatron DX2 functions as a system console for controlling the use of infrared therapy devices such as the Dynatron D880 and Dynatron D890 devices. Indications for Use of these devices are to provide topical heating for temporary increase in blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness, relaxation of muscles, muscle spasms, and minor pain and stiffness associated with arthritis.
Product codes
ITH, ILY
Device Description
Components:
System console, model Dynatron DX2, containing clectric motor and control electronics with LCD alpha-numeric display.
Pull-head or Goniometer attaches patient harnesses and applied force. Feedback from the Goniometer displays force applied and angle of force.
Accessories such as traction belts.
Output ports on the back of the DX2 system consolc accommodate infrared therapy devices such as the Dynatron D880 (K031329) and Dynatron D890 (K040729).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
low back
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
0
CCT 1 2005
Image /page/0/Picture/1 description: The image shows the number K051680 at the top. Below the number is the fraction 4 1/2. The numbers and fraction are written in black ink on a white background. The handwriting is somewhat messy and difficult to read.
SUMMARY OF SAFETY AND EFFECTIVENESS
DYNATRONICS CORPORATION SUBMITTED BY: 7030 Park Centre Drive Salt Lake City UT 84121 Phone: (800) 874-6251; (801) 568-7000; Fax: (801) 568-7711
-
- DEVICE NAME (Trade/common, and classification): Dynatron® DX2TM Combination Traction Unit and Infrared Therapy.
| Classification: | Class II |
|---|---|
| Regulation Nos.: | 890.5900; 890.5500 |
| Product Codes: | ITH, ILY |
2. PREDICATE DEVICES:
Dynatron 900 Traction Unit - cleared under K993919 Lordex Power Traction Unit - cleared under K031227 Dynatron 705 - cleared under K031329
-
- PERFORMANCE STANDARDS: The Dynatron DX2 device conforms to the applicable requirements of 21 CFR sections 1010 (Performance Standards for Electronic Products: General).
4. DESCRIPTION:
Components:
System console, model Dynatron DX2, containing clectric motor and control electronics with LCD alpha-numeric display.
Pull-head or Goniometer attaches patient harnesses and applied force. Feedback from the Goniometer displays force applied and angle of force.
Accessories such as traction belts.
Output ports on the back of the DX2 system consolc accommodate infrared therapy devices such as the Dynatron D880 (K031329) and Dynatron D890 (K040729).
ﺮ ﺃ ﺃﺷﻬﺮ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ
1
-
- INTENDED USE/INDICATIONS FOR USE: The Dynatron DX2 is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back pain. It relieves pain associated with hemiated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.
The Dynatron DX2 functions as a system console for controlling the use of infrared therapy devices such as the Dynatron D880 and Dynatron D890 devices. Indications for Use of these devices are to provide topical heating for temporary increase in blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness, relaxation of muscles, muscle spasms, and minor pain and stiffness associated with arthritis.
- INTENDED USE/INDICATIONS FOR USE: The Dynatron DX2 is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back pain. It relieves pain associated with hemiated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.
The Intended Use/Indications For Usc stated herein are consistent with the cleared indications for the predicate devices.
-
- SUBSTANTIAL EQUIVALENCE (SE) RATIONALE: The Dynatron DX2 shares the same or similar basic characteristics, features and intended use as the predicate devices and, therefore, is substantially equivalent to the Dynatron 900 Traction Unit and the Lordex Power Traction Unit (applicable 'K' numbers listed above) and the Dynatron 705 system console function for controlling infrared therapy devices.
-
- SAFETY AND EFFECTIVENESS: There are no substantive differences between the products defined in this 510(k) submission and the predicate device. They are similar to the technologies that are currently used in other similar medical devices. They were developed and documented under Dynatronics' mature Quality Management System, under the Quality System Regulation, 21 CFR Part 820, under design/change control, and are verified/validated to applicable standards/guidance documents. The products, and accessories, are safe and effective, when used as indicated in specific applications under a clinician's supervision/therapy program.
Signed: ______________________________________________________________________________________________________________________________________________________________________
Dated:
Ronald J. Hatch, VP Operations/RA DYNATRONICS CORPORATION
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract image of an eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.
Public Health Service
OCT 1 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ron Hatch Vice President Operations/Regulatory Affairs Dynatronics Corporation 7030 Park Center Drive Salt Lake City, Utah 84121
Rc: K051680 Trade/Device Name: Dynatron® DX2 Regulation Number: 21 CFR 890.5900 Regulation Name: Power traction equipment Regulatory Class: II Product Code: ITH, ILY Dated: September 23, 2005 Received: September 26, 2005
Dear Mr. Hatch:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2- Ron Hatch
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
- Mark N. Melkerson Acting Director Division of General, Restorative. and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Dynatron® DX2
Indications for Use:
The Dynatron DX2 is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back pain. It relieves pain associated with herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.
The Dynatron DX2 also functions as a system console for controlling the function of infrared therapy devices such as the Dynatron D880 (K031329) and the Dynatron D890 (D040729). Indications for use of these infrared therapy devices are to provide topical heating for temporary increase in blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness, relaxation of muscles, muscle spasms, and minor pain and stiffness associated with arthritis.
Prescription Use メ (Part 21 (FR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRIH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
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