(90 days)
Not Found
No
The device description details a purely electromechanical device with manual operation and fixed force settings. There is no mention of adaptive behavior, learning, or data processing that would indicate AI/ML.
Yes
The device is described as an "Adjusting Instrument" for "adjustment, mobilization, or manipulation of the musculoskeletal joints of the spine and/or extremities" by a licensed health care professional, which directly addresses therapeutic intervention. It is intended to treat physical conditions through mechanical force.
No
Explanation: The device is described as an "Adjusting Instrument" for "adjustment, mobilization, or manipulation of the musculoskeletal joints." Its function is to deliver a therapeutic thrust, not to diagnose a condition.
No
The device description clearly outlines numerous hardware components including a hand-held electromechanical instrument, shaft, handle, force adjustment switch, trigger, preload control nose, stylus, power cord, circuit board, power supply, internal thrust element, solenoid, and internal spring. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "adjustment, mobilization, or manipulation of the musculoskeletal joints of the spine and/or extremities." This is a physical intervention on the body.
- Device Description: The description details a hand-held electromechanical instrument used for physical manipulation. It describes mechanical components, force delivery, and contact with the patient's body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The device is clearly intended for direct physical treatment of the musculoskeletal system, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Impulse™ (aka Neuromechanical™, aka CBP®) Adjusting Instrument is for adjustment, mobilization, or manipulation of the musculoskeletal joints of the spine and/or extremities by a licensed health care professional. The device is for external use only.
Product codes
LXM
Device Description
Impulse "" (aka Neuromechanical™, aka CBP®) Adjusting Instrument is a hand-held electromechanical chiropractic adjusting instrument intended to be used for chiropractic adjustment or manipulation/mobilization of the joints of the spine and extremities. The device is only intended for use from a health care professional licensed by the law of the state that he or she practices.
The instrument's shaft measures approximately 15 cm in length and 3.5 cm in width. The instrument's handle is rigidly attached to the shaft and measures approximately 10 cm in length. The external housing of the device consists of high impact plastic that surrounds its main internal components. The major external components of the device consist of the instrument's shaft, handle, force adjustment switch, trigger, preload control nose, stylus and power cord. Three types of interchangeable stainless steel stylus' attach to the preload control nose which make contact with the patient by means of a neoprene rubber end. The major internal components of the device consist of a circuit board, power supply, internal thrust element, solenoid, internal spring. Both external and internal views of the device are shown in Figure 1. Stylus specifications are shown in Figure 2, illustrating the three kinds of stylus', a single stylus, and two double contact stylus' that allows for dual contact to each side of the spine simultaneously. These styluses have been designed for appropriate anatomical contact with the spine.
The instrument is manually triggered by the operator and contains a safety mechanism consisting of a triggering mechanism that does not allow for activation of the device unless the preload control spring is maximally compressed. In this manner, the clinician (operator) is able to test the patient's tolerance to contact prior to the instrument being able to be activated. The device is equipped with a force adjustment switch which allows for control of force produced by the instrument, high, medium, and low, representing transmitted peak forces of 265 N, 150 N, and 50 N respectively. Peak forces for all three settings are delivered in less than 5 ms.
The device is operated in the following manner. After locating the target area to be treated the rubber end of the stylus makes contact with the treatment location. An approximate 15 N of preload force compresses the spring allowing for activation of the instrument's trieger mechanism. The operator is then able to manually trigger the device to deliver a single thrust ranging from 50 - 265 N depending on the force setting used.
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
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
Study Type: Laboratory setting comparison of force transmission
Sample Size: 90 trials (10 thrusts for each of three force settings for each of three devices)
Key Results: The Impulse device produced average peak forces of 55.8 N, 150.5 N, and 254.4 N (pulse duration
N/A
0
JAN 1 3 2003
510(k) Summary Impulse " Adjusting Instrument; also known as (aka) Neuromechanical Adjusting Instrument"; aka CBP® Adjusting Instrument Neuromechanical Innovations, LLC Manufacturer: 11011 S. 48th St., Suite 205 Phoenix, AZ 85044
- Christopher J. Colloca, D.C. Contact: Phone: 480-785-8442 Fax: 480-893-2412 Email: cicolloca(@neuromechanical.com
Jeff Green
Contract Manufacturer: FA Green 9742 352nd Ave., S.E. Snoqualmie, WA 98065
Contract Manufacturer Contact:
Trade Name(s):
Impulse™ Adjusting Instrument aka (also known as) Neuromechanical Adjusting Instrument™ aka (also known as) CBP® Adjusting Instrument
Manipulator, Plunger-like Joint
K003185 - Full Spectrum Activator III
K973506 ~ Activator II Adjusting Instrument
K930431 - Arthrostim
K010851 - Harrison Hand Held Adjusting Instrument
K001476 - Torque Specific Cervical Adjusting Instrument
Telephone: (425) 888-0007
Facsimile: (425) 888-0675 Email: sensors@centurytel.net
Chiropractic Adjusting Instrument Common or Usual Name:
Classification Name:
Predicate Devices for Substantial Equivalence:
Applied for herein. Establishment Registration #:
Classification: Unclassified Physical Medicine Panel:
R. A. Fisher, Natural Selection and Variation
Performance Standards: None known established
1
Device Description & Specifications:
(aka Neuromechanical™, aka CBP®) Adjusting Instrument is a hand-held Impulse "" electromechanical chiropractic adjusting instrument intended to be used for chiropractic adjustment or manipulation/mobilization of the joints of the spine and extremities. The device is only intended for use from a health care professional licensed by the law of the state that he or she practices.
The instrument's shaft measures approximately 15 cm in length and 3.5 cm in width. The instrument's handle is rigidly attached to the shaft and measures approximately 10 cm in length. The external housing of the device consists of high impact plastic that surrounds its main internal components. The major external components of the device consist of the instrument's shaft, handle, force adjustment switch, trigger, preload control nose, stylus and power cord. Three types of interchangeable stainless steel stylus' attach to the preload control nose which make contact with the patient by means of a neoprene rubber end. The major internal components of the device consist of a circuit board, power supply, internal thrust element, solenoid, internal Both external and internal views of the device are shown in Figure 1. Stylus spring. specifications are shown in Figure 2, illustrating the three kinds of stylus', a single stylus, and two double contact stylus' that allows for dual contact to each side of the spine simultaneously. These styluses have been designed for appropriate anatomical contact with the spine.
The instrument is manually triggered by the operator and contains a safety mechanism consisting of a triggering mechanism that does not allow for activation of the device unless the preload control spring is maximally compressed. In this manner, the clinician (operator) is able to test the patient's tolerance to contact prior to the instrument being able to be activated. The device is equipped with a force adjustment switch which allows for control of force produced by the instrument, high, medium, and low, representing transmitted peak forces of 265 N, 150 N, and 50 N respectively. Peak forces for all three settings are delivered in less than 5 ms.
The device is operated in the following manner. After locating the target area to be treated the rubber end of the stylus makes contact with the treatment location. An approximate 15 N of preload force compresses the spring allowing for activation of the instrument's trieger mechanism. The operator is then able to manually trigger the device to deliver a single thrust ranging from 50 - 265 N depending on the force setting used.
Substantial Equivalence Comparison:
Impulse™ (aka Neuromechanical™, aka CBP®) Adjusting Instrument is substantially equivalent to other FDA registered predicate hand-held chiropractic adjusting instruments. Specifically, Impulse™ (aka Neuromechanical™, aka CBP®) Adjusting Instrument has the same intended use, similar technological characteristics, and similar force-time profiles as predicate devices. The current device, perhaps, is most similar in structure and function to the Harrison Hand Held Adjusting Instrument (K010851). Both hand-held adjusting instruments generate the force to protrude the stylus a controlled distance by means of electrical power that transiently charges a solenoid. The current device, however, has several noteworthy technological characteristics that are similar to predicate devices. Therefore, Table 1 has been prepared to provide a comparison of technological characteristics of the the current device and predicate devices.
2
| Feature | Impulse* | Harrison | Arthrostim | Activator
II | Activator
III |
|-------------------------------------------------------------|----------|----------|------------|-----------------|------------------|
| Intended use is chiropractic
adjustment of the spine? | Yes | Yes | Yes | Yes | Yes |
| Hand-held adjusting device? | Yes | Yes | Yes | Yes | Yes |
| Manually activated thrust? | Yes | Yes | Yes | Yes | Yes |
| Single thrust per activation? | Yes | Yes | No | Yes | Yes |
| Thrust force delivered from
spring energy? | No | No | No | Yes | Yes |
| Thrust force delivered from
powered solenoid activation? | Yes | Yes | Yes | No | No |
| Adjustable force transmission | Yes | Yes | Yes | Yes | Yes |
| Preload control spring | Yes | No | No | No | Yes |
| Rubber contact end on stylus | Yes | Yes | Yes | Yes | Yes |
Table 1. Substantial equivalence comparison for the current device (*), the Harrison Hand Held Device (K010851), Arthrostim (K930431), Activator II (K973506), and Activator III (K003185).
Force Transmission Comparison Among Chiropractic Adjusting Devices
The force of the current device (Impulse" Adjusting Instrument) was compared to the Harrison Hand Held Adjusting Instrument (K010851), and the Activator® II Adjusting Instrument (K973506) in a laboratory setting. Ten thrusts were delivered into a load cell (2200 N quartz force ring, PCB model 201A03, PCB Piezotronics, Buffalo, NY') mounted to a table top for each of three force settings for each of the three devices. Collectively, ninety trials were performed, thirty trials with each device consisting of ten trials at each of the three force settings.
Figure 3 provides a comparison of force transmission among the three devices for each of the three force settings. The Impulse "device was found to produce an average peak force of 55.8 N, 150.5 N, and 254.4 N respectively (pulse duration