(133 days)
HRI, Inc., Arthrostim K930431
No
The device description and performance studies describe a purely mechanical chiropractic adjusting instrument with no mention of computational or data-driven components.
Yes
The device is indicated for chiropractic adjustment of the spine and extremities, which is a therapeutic intervention.
No
The device description clearly states its purpose is for "chiropractic adjustment of the spine and extremities" and as a "chiropractic adjusting instrument for use in spinal manipulative therapy." It does not mention any function for diagnosing conditions or diseases.
No
The device description clearly outlines physical components like handles, a thrust element, a spring, and an adjustment knob, indicating it is a hardware device.
Based on the provided information, the Activator II® is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "chiropractic adjustment of the spine and extremities." This is a physical manipulation of the body.
- Device Description: The device is a mechanical instrument used for applying force to the body. It does not involve the examination of specimens derived from the human body (like blood, urine, tissue, etc.).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the body to provide information for diagnosis, monitoring, or screening. The Activator II® is a therapeutic device used for physical treatment.
N/A
Intended Use / Indications for Use
The Activator II® is indicated for chiropractic adjustment of the spine and extremities.
Product codes
LXM
Device Description
The Activator II ® is a chiropractic adjusting instrument for use in spinal manipulative therapy. The instrument is approximately seven (7) inches in length and approximately 2.5 inches wide at the handles. The major components of the device include handles for holding the device and applying thrust, a thrust element for delivering an input force to the patient, a body contact member, a spring for propelling the thrust element, and an adjustment knob. The body contact member is manufactured from silicone rubber. The adjustment knob is used for manually adjusting the amount of potential energy imposed on the spring and for controlling the magnitude of the resulting input force. When the handle is depressed, the body contact member applies the force in a specific line of drive at a rapid speed. This action is similar to a practitioner manually applying thumb thrust at specific contact points to achieve chiropractic adjustment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spine and extremities.
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
This Activator II’s was tested on a human subject and an animal subject.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data for the Activator II 6 has been published in the Journal of Manipulative and Physiological Therapeutics, Volume 9, Number 1, March 1986. In this study, entitled "Accuracy of Piezoelectric Accelerometers Measuring Displacement of a Spinal Adjusting Instrument," an electronic system to measure the displacement of the Activator II'® instrument was examined/ Results demonstrate the effectiveness of the instruments to cause vertebral movement for chiropractic adjustment at very low energy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
preamendments device Activator Methods Phoenix, Arizona Integrator K950646 HRI, Inc. Arthrostim K930431
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image is a black and white logo. The logo is circular and contains a stylized mountain range at the top. Below the mountain range are several horizontal lines that could represent water or land. The overall design is simple and abstract.
DR. ARLAN W. FUHR, PRESIDENT AND CO-FOUNDER
JAN 27 1998
510(k) Summary- Activator II(8)
September 11, 1997
Manufacturer:
Activator Methods, Inc. 3714 E. Indian School Road Phoenix, Arizona 85060-0317
Contact:
Arlan W. Fuhr, D.C. phone: (602) 224-0220 fax: (602) 224-0230
chiropractic adjusting device
Plunger-like joint manipulator
Trade name:
Common name:
Classification name:
Device Description:
.
Activator® Substantially equivalent to: preamendments device Activator Methods Phoenix, Arizona Integrator K950646 HRI, Inc. Arthrostim K930431
Activator II®
The Activator II ® is a chiropractic adjusting instrument for use in spinal manipulative therapy. The instrument is approximately seven (7) inches in length and approximately 2.5 inches wide at the handles. The major components of the device include handles for holding the device and applying thrust, a thrust element for delivering an input force to the patient, a body contact member, a spring for propelling the thrust element, and an adjustment knob. The body contact member is manufactured from silicone rubber. The adjustment knob is used for manually adjusting the amount of potential energy imposed on the spring and for controlling the magnitude of the resulting input force. When the handle is depressed, the body contact member applies the force in a specific line of drive at a rapid speed. This action is similar to a practitioner manually applying thumb thrust at specific contact points to achieve chiropractic adjustment.
Freeman Procedure Seminars
1
Image /page/1/Picture/0 description: The image shows the logo for Activator Methods, Inc. The logo includes a circular graphic on the left and the company name in bold, black letters. Below the company name is the text "DR. ARLAN W. FUHR, PRESIDENT AND CO-FOUNDER".
Intended Use:
chiropractic adjustment of the spine and extremities.
Comparison to predicate device:
| Indicated for chiropractic
| adjustment of the spine? | yes | yes |
|---|---|---|
| Hand held adjusting device? | yes | yes |
| Impact force derived by | ||
| spring energy? | yes | yes |
| Adjustable impact force? | yes | yes |
| Silicone rubber body contact | ||
| member? | yes | yes |
| Weighted anvil tip? | no | yes |
Table 1. Substantial Equivalence Comparison
Summary of data upon which substantial equivalence was based:
As a result of the research on the Activator 10 which included a 46 gram weighted anvil tip, the formation of the Activator II(8) evolved. This Activator II's was tested on a human subject and an animal subject. Performance data for the Activator II 6 has been published in the Journal of Manipulative and Physiological Therapeutics, Volume 9, Number 1, March 1986. In this study, entitled "Accuracy of Piezoelectric Accelerometers Measuring Displacement of a Spinal Adjusting Instrument," an electronic system to measure the displacement of the Activator II'® instrument was examined/ Results demonstrate the effectiveness of the instruments to cause vertebral movement for chiropractic adjustment at very low energy.
very low energy.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized symbol that resembles a bird or a series of human profiles. The symbol is composed of three curved lines that create a sense of movement or flow.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 27 1998
Arlan W. Fuhr, D.C. · President Activator Methods, Inc. 3714 East Indian School Road Phoenix, Arizona 85018
Re: K973506 Activator II® Requlatory Class: Unclassified Product Code: LXM Dated: December 4, 1997 December 16, 1997 Received:
Dear Dr. Fuhr:
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 Requlations, Title 21, Parts 800 to 895. ನ್ನ 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 requlation may result in regulatory action. In addition, FDA may publish further announcements Please note: concerning your device in the Federal Reqister. 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.
3
Page 2 - Arlan W. Fuhr, D.C.
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 requlation (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.qov/cdrh/dsmamain.html".
Sincerely yours,
Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number:________________________________________________________________________________________________________________________________________________________________
Device Name:__________________________________________________________________________________________________________________________________________________________________
and the comments of the
.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
,
Indications for Use: The Activator II® is indicated for chiropractic adjustment of the spine
and extremities. and extremit
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CRDH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | L473506 |
| Prescription Use | X (Per 21 CFR 801.109) | OR | Over-the Counter Use | |
|---|---|---|---|---|
| ------------------ | ------------------------------------------------------------------------ | ---- | ---------------------- | -------------------------------------------------- |