IMPULSE IQ ADJUSTING INSTRUMENT

K080261 · Neuromechanical Innovations, LLC · LXM · Apr 11, 2008 · PM

Device Facts

• Record ID: K080261
• Device Name: IMPULSE IQ ADJUSTING INSTRUMENT
• Applicant: Neuromechanical Innovations, LLC
• Product Code: LXM · PM
• Decision Date: Apr 11, 2008
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The Impulse iQ Adjusting Instrument is intended for chiropractic adjustment, mobilization, or manipulation of the musculoskeletal joints of the spine and/or extremities, or for soft-tissue musculoskeletal mobilization by a licensed health care professional only. For external use only.

Device Story

Impulse iQ Adjusting Instrument is a hand-held electromechanical device for chiropractic joint and soft-tissue mobilization. Device features three force settings (100 N, 200 N, 400 N) and an internal accelerometer for closed-loop feedback. Operator applies device to patient; preload-control indicator light (red to green) signals when proper preload is achieved. Accelerometer controls thrust pulse rate (4-12 Hz). Used by licensed healthcare professionals in clinical settings. Provides controlled mechanical force to musculoskeletal structures to facilitate adjustment or mobilization.

Clinical Evidence

Bench testing only. Mechanical testing confirmed force outputs of approximately 100 N, 200 N, and 400 N at low, medium, and high settings, respectively. Pulse rate verified between 4-12 Hz. No clinical data provided.

Technological Characteristics

Hand-held electromechanical chiropractic adjusting instrument. Features three force settings (100/200/400 N) and internal accelerometer for closed-loop feedback. Includes preload-control indicator light. Operates at 4-12 Hz pulse rate. External use only.

Indications for Use

Indicated for chiropractic adjustment, mobilization, or manipulation of musculoskeletal joints of the spine and/or extremities, or soft-tissue musculoskeletal mobilization. Intended for use by licensed healthcare professionals only. External use only.

Predicate Devices

• Impulse Adjusting Instrument (K023462)
• Arthrostim Manipulator (K930431)
• FRAS, Sense Technology, Inc. (K973914)
• Full Spectrum Activator III (K003185)
• Harrison Hand Held Adjusting Instrument (K010851)

Submission Summary (Full Text)

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| 510(k) Summary | K080261 | | | APR 11 2008 |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------|-----------------------------------------|--|-------------|
| Device Name: | Impulse iQ Adjusting Instrument | | | |
| Manufacturer: | Neuromechanical Innovations, LLC<br>11011 S. 48th St., Suite 205<br>Phoenix, AZ 85044 | | | |
| Contact: | Christopher J. Colloca, D.C.<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | | | |
| Trade Name(s): | Impulse iQ Adjusting Instrument or Impulse iQ | | | |
| Common or Usual Name: | Chiropractic Adjusting Instrument | | | |
| Product Code: | LXM | | | |
| Classification Name: | Manipulator, Plunger-like Joint | | | |
| Classification: | Unclassified | | | |
| Predicate Devices for<br>Substantial Equivalence: | K023462 | Impulse Adjusting Instrument | | |
| | K930431 | Arthrostim Manipulator | | |
| | K973914 | FRAS, Sense Technology, Inc. | | |
| | K003185 | Full Spectrum Activator III | | |
| | K010851 | Harrison Hand Held Adjusting Instrument | | |
| Panel: | Physical Medicine | | | |

Performance Standards: None known established

The Impulse iQ Adjusting Instrument has been mechanically tested Performance Data: and found to produce approximately 100 N, 200 N, and 400 N on its low, medium, and high force settings respectively. Total peak force output is also dependent upon operator preload. The pulse rate varies between 4-12 Hz.

Device Description & Specifications: The Impulse iQ Adjusting Instrument is a hand-held electromechanical chiropractic adjusting instrument. The device has three force settings (low, medium, high), a preload-control indicator light that turns from red to green upon achieving the proper preload, and an internal accelerometer to provide closed-loop feedback controlling thrust pulse rate. The device is only intended for use from a health care professional licensed by the law of the state that he or she practices.

Intended Use: The Impulse iQ Adjusting Instrument is intended for chiropractic adjustment, mobilization, or manipulation of the musculoskeletal joints of the spine and/or extremities, or for soft-tissue musculoskeletal mobilization by a licensed health care professional only. For external use only.

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APR 1 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Neuromechanical Innovations, LLC % Christopher J. Colloca, D.C. 11011 S. 48th Street, Suite 205 Phoenix, Arizona 85044

Re: K080261 Trade/Device Name: Impulse iQ Adjusting Instrument Regulatory Class: Unclassified Product Code: LXM Dated: March 20, 2008 Received: March 25, 2008

Dear Dr. Colloca:

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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

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Page 2 - Christopher J. Colloca, D.C.

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 [phone]. 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 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 toll-free number [phone] or [phone] or Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M Millman

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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## Indications for Use Statement

## 510(k) Number: K080261

## Impulse iQ Adjusting Instrument Intended Use:

The Impulse iQ Adjusting Instrument is intended for chiropractic adjustment, mobilization, or manipulation of the musculoskeletal joints of the spine and/or extremities, or for soft-tissue musculoskeletal mobilization by a licensed health care professional only. For external use only.

Prescription Use

Over-The-Counter Use_

(Part 21 CFR801 Subpart D)

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil RP Order for mxm

(Division Sign-Off Division of General, Restorative, and Neurological Devices

510(k) Number K080261