(46 days)
Not Found
No
The summary describes a purely mechanical/electromechanical device with adjustable thrust settings, and there is no mention of AI, ML, or any data processing that would suggest such technology.
Yes
The device is described as an instrument for chiropractic adjustment of the spine and extremities, which is a therapeutic intervention.
No
Explanation: The device is described as an "electromechanical chiropractic adjusting instrument" used for "chiropractic adjustment of the spine and extremities." Its purpose is to deliver a thrust, which is a therapeutic action, not to diagnose a condition.
No
The device description explicitly states it is a "hand-held electromechanical chiropractic adjusting instrument" with a "plunger-like mechanism" and is "battery powered," indicating it is a physical hardware device.
Based on the provided information, the Activator V is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "chiropractic adjustment of the spine and extremities." This is a physical manipulation of the body, not a test performed on samples taken from the body.
- Device Description: The device is described as a "hand-held electromechanical chiropractic adjusting instrument." This further reinforces its function as a physical therapy tool.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.
The Activator V is a therapeutic device used for physical treatment, not a diagnostic tool that analyzes samples.
N/A
Intended Use / Indications for Use
The Activator V is indicated for chiropractic adjustment of the spine and extremities. It is intended for external use only.
Product codes
LXM
Device Description
The Activator V is a hand-held electromechanical chiropractic adjusting instrument with a plunger-like mechanism that is intended to be used for chiropractic adjustment of the spine and extremities. The device is only intended to be used by a health care professional licensed by the state in which he or she practices. The thrust is provided by battery power rather than manual force. This makes it easier and less tiring for the chiropractor.
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
health care professional licensed by the state in which he or she practices.
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
The Activator V has been mechanically tested and shown to deliver approximately 75,125, 175 or 250 N, depending on the selected thrust setting. The rechargeable battery has been tested for safety and performance by the battery manufacturer.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
OCT 2 % 2007 510(k) Summary of Safety and Effectiveness 6.
This 510(k) Summary of Safety and Effectiveness for the Activator V is submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990 and follows the Office of Device Evaluation (ODE) guidance concerning the organization and content of a 510(k) Summary.
| Applicant: | Activator Methods International Ltd. |
|---|---|
| Address: | 2950 N. Seventh Street, Suite 200 |
| Phoenix, AZ 85014 USA | |
| Contact Person: | Arlan W. Fuhr, D.C. |
| Telephone: | 602-224-0220 |
| Fax: | 602-224-0230 |
| Preparation Date: | September 4, 2007 |
| Device Trade Name: | Activator V |
| Common Name: | Chiropractic adjusting instrument |
| Classification Name: | Plunger-like joint manipulator |
| Product Code: | LXM |
| Legally Marketed | K003185, Full Spectrum Activator III |
| Predicates: | K010851, Harrison Hand Held Adjusting Instrument |
| K023462, Impulse Adjusting Instrument | |
| Device Description: | The Activator V is a hand-held electromechanical |
| chiropractic adjusting instrument with a plunger-like | |
| mechanism that is intended to be used for chiropractic | |
| adjustment of the spine and extremities. The device is | |
| only intended to be used by a health care professional | |
| licensed by the state in which he or she practices. The | |
| thrust is provided by battery power rather than manual | |
| force. This makes it easier and less tiring for the | |
| chiropractor. | |
| Intended Use: | The Activator V is indicated for chiropractic adjustment |
| of the spine and extremities. It is intended for external | |
| use only | |
| Performance Data: | The Activator V has been mechanically tested and shown |
| to deliver approximately 75,125, 175 or 250 N, | |
| depending on the selected thrust setting. The | |
| rechargeable battery has been tested for safety and | |
| performance by the battery manufacturer. | |
| Conclusion: | The Activator V is substantially equivalent to the |
| predicate plunger-like chiropractic adjustment devices | |
| with respect to intended use, performance, and | |
| technological characteristics. |
.
.
1
510(k) Summary of Safety and Effectiveness for the Activator V, continued:
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, clutching a staff with two snakes wrapped around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the logo.
OCT 2 3 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Activator Methods International, Ltd. % Arlan W.Fuhr, D.C. President 2950 North 7th Street, Suite 200 Phoenix, Arizona 85014
Re: K072519
Trade/Device Name: Activator V Spinal Adjusting Instrument Regulatory Class: Unclassified Product Code: LXM Dated: September 4, 2007 Received: September 7, 2007
Dear Dr. Fuhr:
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 - Arlan W.Fuhr, D.C.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at 240-276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark A. Milhusan
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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5. Indications for Use Statement
Activator V Spinal Adjusting Instrument Intended Use:
The Activator V is indicated for chiropractic adjustment of the spine and extremities. It is intended for external use only.
X Prescription Use (Part 21 CFR 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Milliken
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K07
.