(70 days)
Not Found
No
The device description mentions an internal accelerometer providing "closed-loop feedback controlling thrust pulse rate," which is a form of automated control based on sensor input, not necessarily AI/ML. There are no mentions of AI, ML, deep learning, training data, or performance metrics typically associated with AI/ML algorithms.
Yes
The device is described as an "Adjusting Instrument" intended for "chiropractic adjustment, mobilization, or manipulation of the musculoskeletal joints," which are therapeutic actions.
No
Explanation: The device is described as an "Adjusting Instrument" intended for "chiropractic adjustment, mobilization, or manipulation," which are therapeutic procedures, not diagnostic ones. It performs mechanical actions (producing force, varying pulse rate) rather than detecting, analyzing, or interpreting biological signals or images to identify a disease or condition.
No
The device description explicitly states it is a "hand-held electromechanical chiropractic adjusting instrument," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for chiropractic adjustment, mobilization, or manipulation of musculoskeletal joints and soft tissue. This is a physical intervention performed on the patient's body.
- Device Description: The device is a hand-held electromechanical instrument that applies force and vibration. 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 be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly operates in vivo (on the body) for therapeutic purposes.
N/A
Intended Use / Indications for 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.
Product codes
LXM
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
musculoskeletal joints of the spine and/or extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed health care professional only.
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 Impulse iQ Adjusting Instrument has been mechanically tested 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.
Key Metrics
Not Found
Predicate Device(s)
K023462, K930431, K973914, K003185, K010851
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
| 510(k) Summary | K080261 | APR 11 2008 | ||
|---|---|---|---|---|
| Device Name: | Impulse iQ Adjusting Instrument | |||
| Manufacturer: | Neuromechanical Innovations, LLC | |||
| 11011 S. 48th St., Suite 205 | ||||
| Phoenix, AZ 85044 | ||||
| Contact: | Christopher J. Colloca, D.C. | |||
| Phone: 480-785-8442 | ||||
| Fax: 480-785-3916 | ||||
| Email: DrC100@aol.com | ||||
| 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 | ||||
| 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 (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 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 (800) 638-2041 or (240) 276-3150 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