ACTIVATOR V-E

K112606 · Activator Methods International, Ltd. · LXM · Mar 6, 2012 · PM

Device Facts

• Record ID: K112606
• Device Name: ACTIVATOR V-E
• Applicant: Activator Methods International, Ltd.
• Product Code: LXM · PM
• Decision Date: Mar 6, 2012
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The Activator V-E is indicated for chiropractic adjustment of the spine and extremities. It is intended for external use only.

Device Story

Activator V-E is an electromechanical spinal adjusting instrument used by chiropractors for manual manipulation of the spine and extremities. Device delivers controlled, mechanical force to specific anatomical sites to facilitate joint adjustment. Operated by a clinician, the instrument provides a consistent, repeatable force compared to manual adjustment techniques. It is intended for external use only. The device assists the practitioner in performing chiropractic adjustments, potentially improving patient comfort and treatment precision.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Electromechanical spinal adjusting instrument. Features an electronic force delivery system, replacing the manual spring-loaded mechanism of the predicate. Designed for external use. Operates via electrical power source. Form factor is a handheld instrument for clinical use.

Indications for Use

Indicated for chiropractic adjustment of the spine and extremities in patients requiring manual manipulation.

Predicate Devices

• Activator II (K831566)

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Activator Methods International, Ltd. % Mr. Arlan W. Fuhr Co-Founder and CEO 2950 North Seventh Street, Suite 200 Phoenix, Arizona 85014

MAR - 6 2012

Re: K112606

Trade/Device Name: Activator V-E Spinal Adjusting Instrument Regulatory Class: Unclassified

Product Code: LXM Dated: February 17, 2012 Received: February 21, 2012

Dear Mr. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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## Page 2 - Mr. Arlan W. Fuhr

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement 5.

## Activator V-E Spinal Adjusting Instrument Intended Use:

The Activator V-E is indicated for chiropractic adjustment of the spine and extremities. It is intended for external use only. .

Prescription Use X (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)

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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K112606