SMART ADJUSTER (SA201)

K962239 · Sigma · LXM · Jan 10, 1997 · PM

Device Facts

• Record ID: K962239
• Device Name: SMART ADJUSTER (SA201)
• Applicant: Sigma
• Product Code: LXM · PM
• Decision Date: Jan 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

This device will be used by chiropractors to as an additional analysis tool to help identify areas of fixation and/or subluxation of the human spine. Additionally, it will allow the doctors to perform mechanical adjustments to the human spine.

Device Story

Smart Adjuster; chiropractic adjusting unit. Input: percussive force applied to spine via handheld transducer. Operation: transducer measures rebound force (percussive force minus force absorbed by tissue); computer processes data to generate histogram map of vertebral segments. Output: visual histogram display of spinal rebound force. Usage: clinic setting; operated by chiropractor. Clinical workflow: doctor samples spinal reaction; identifies fixation/subluxation; applies measured percussive force (up to 35 lbs) for adjustment; repeats analysis to compare pre- and post-adjustment histograms. Benefit: provides objective data for spinal assessment and adjustment precision.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System consists of computer, control unit, and handheld transducer. Measures percussive force rebound. Force application up to 35 lbs. Software-controlled display and settings. Standalone system.

Indications for Use

Indicated for use by chiropractors to identify spinal fixation/subluxation and perform mechanical spinal adjustments in patients requiring chiropractic care.

Predicate Devices

• Force Recording and Adjusting System (FRAS) (K940085)

Submission Summary (Full Text)

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K962239

# Premarket Notification [510(k)] Summary

Date: September 7, 1996

JAN 10 1997

Tamas Becse
c/o Sigma Co.
175 William Pitt Way
Pittsburgh, PA 15238

Phone: [phone]
Fax: [phone]

Contact Person: Tamas Becse

Trade Name: Smart Adjuster
Common Name: Chiropractic Adjusting Unit
Classification name: Unclassified

## Equivalent Device:

Force Recording and Adjusting System (FRAS). 510(k) Number K940085. Marketed by Sense Technology, Inc.

## Description of the Device:

The Smart Adjuster is a device that is equivalent to the Force Recording and Analysis System (FRAS), 510(k) Number K940085. Below is a list of similarities and differences between the two devices. Both devices are designed to measure force rebound, display results and perform mechanical adjustments to the human spine. These types of adjustments are performed by chiropractors.

The Smart Adjuster consists of three distinct units. The first is a computer with software that controls the displays and settings of the hardware portion of the system. The hardware part of the system functions as a control unit for the hand help transducer unit. The transducer unit (head) is used by the doctor to sample the reaction of the spine and overlaying tissue to the introduction of a measured percussive force. The reaction at the site of the percussion is recorded as a rebound force. That is, part of the percussive force is absorbed and dissipated by the patient’s body and part of the force is rebounded to the point of entry back to the transducer. The difference is calculated and the rebound force is recorded and displayed as a single bar component of a histogram of several contract points over the patient’s back coincident with the anatomical location of the vertebral segments. This allows the doctor to view a “map” of the dissipation and rebound of an application of a measured amount of force into the back of the patient.

The chiropractor, by virtue of education and training, can determine if and where an adjustive force should be applied to the patient in order to facilitate a “chiropractic adjustment” of the patient’s spine. The force can be applied with the Smart Adjuster or by any other means normally available and used by chiropractors. When using the Smart Adjuster as an adjusting tool, the chiropractor may select a measured force, up to 35 pounds, and apply that force to a very specific location, determined by education and experience, on the patient. When the “adjustment phase” of the treatment is completed, the chiropractor precisely repeats the analysis phase. This device will again record and display the results and will then compare the results, as duplicate histograms, so the pre-adjustment and post-adjustment results may be observed.

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# Premarket Notification [510(k)] Summary Cont.

## Intended Use of the Device:

This device will be used by chiropractors to as an additional analysis tool to help identify areas of fixation and/or subluxation of the human spine. Additionally, it will allow the doctors to perform mechanical adjustments to the human spine.

## Comparison to Existing Device:

Please see ATTACHMENT B and TABLE B provided in the original submission and the amendments provided in this correspondence.