The Back on Trac (BOTGEN1) and Cervi-Trac Systems are in professional healthcare facilities, to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, shoulder).

Back on Trac
The Back on Trac (BOTGEN1) is intended for use to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, shoulder)". The device may be used to manage and reduce pain associated with the following conditions:

facet syndrome,
herniated disc,
protruding disc,
extruded disc,
sciatica,
spondylosis (degenerative disc disease & facet syndrome),
joint pain.

Vibration and heat are available options that can be utilized with the Back on Trac (BOTGEN1) at the discretion of the healthcare professional. When activated, the vibration mode can provide muscle relaxation and temporary relief of minor aches and pains. The heat mode, when activated, can provide temporary relief of minor aches and pains. The local warmth temporarily stimulates local blood circulation in your lower back.

Cervi-Trac
The Cervi-Trac is intended for use as an accessory to the Back on Trac (BOTGEN1) to relieve pressures on structures that may be causing pain of skeletal or muscular origin. The Cervi-Trac accessory focuses specifically on the cervical region.

Device Description

The Ergo-Flex Technologies Systems that are the subject of this premarket notification are prescription use only and are intended for use by licensed, qualified healthcare professionals, such as physicians, chiropractors, physical therapists, etc.

Ergo-Flex Back on Trac System:
The (BOTGEN1) is comprised of a reclinable therapeutic cushioned chair with back support portion and a second lower back, upper and lower leg support section that is movable in an axial direction with respect to the back support section and is also arcuately movable about a pivot axis that is perpendicular to the axial direction. The chair includes remotely controlled linear actuators to control the relative movement of the different sections of the device.

Ergo-Flex Cervi-Trac:
The Cervi-Trac (CT) is an accessory to the Back on Trac (BOTGEN1) that focuses specifically on the cervical region. The patient is not restrained by the Back on Trac arm bolsters, therefore lumbar traction is not activated by the Cervi-Trac during this therapy.

AI/ML Overview

This document is a 510(k) summary for the Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac devices. It demonstrates substantial equivalence to a predicate device, as opposed to proving the device meets specific performance criteria through a clinical study. Therefore, the information requested regarding acceptance criteria, study design, ground truth establishment, and expert involvement is not applicable in the context of this document.

Here's why and what information is provided:

510(k) Premarket Notification: This is a regulatory pathway used to demonstrate that a new medical device is "substantially equivalent" to a legally marketed predicate device. It generally relies on non-clinical performance data and a comparison of technological characteristics, rather than de novo clinical efficacy studies with specific acceptance criteria that would typically be required for novel devices or those seeking a new indication.

Based on the provided document, here's what can be stated regarding the requested categories:

A table of acceptance criteria and the reported device performance:
- Not Applicable. This document does not present a table of acceptance criteria and reported device performance in the way a clinical trial or performance study would. The acceptance is based on demonstrating "substantial equivalence" to a predicate device, which is achieved by showing similar intended use and technical/functional characteristics, and adherence to relevant consensus standards.
- Instead, the document provides a "Comparison of the IFU and Technical Specifications and Performance Characteristics" (Table 1 on page 9) between the subject device and the predicate device. This table highlights similarities and differences in parameters like intended use, environment, treatment areas, electrical safety, EMC, and traction mechanism.
- For performance, it states: "Performance testing on the Back on Trac (BOTGEN1) and Cervi-Trac Systems demonstrated the design, operational and functional parameters and safety features met the established specifications for each device and demonstrate performance substantial that is equivalent to the predicate device." However, specific numerical performance metrics are not listed as "acceptance criteria" but rather as "specifications" met.
Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not Applicable. The submission did not involve clinical testing to demonstrate substantial equivalence. Therefore, there are no "test sets" of patient data in the typical sense for clinical performance.
- The "testing" mentioned refers to non-clinical performance testing and compliance with recognized consensus standards (e.g., IEC 60601-1 for electrical safety, ISO 14971 for risk management). These are tests on the device itself, not on patient samples.
- Data provenance for such non-clinical testing is typically internal company data or reports from certified testing facilities, not patient data from specific countries or study designs.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not Applicable. Since no clinical test set with patient data was used to establish "ground truth" for efficacy or diagnostic performance, there were no experts establishing such ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No clinical test set requiring adjudication was used.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. No MRMC study was conducted. This device is "Power traction equipment," which is a physical therapy device, not an AI or diagnostic imaging device that would typically involve human readers or AI assistance in interpretation.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is not an algorithm-based device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. No ground truth for clinical efficacy or diagnostic accuracy was established as part of this 510(k) submission. Substantial equivalence is based on engineering and performance characteristics compared to a predicate device, and compliance with safety standards.
The sample size for the training set:
- Not Applicable. As this is not an AI/machine learning device, there is no "training set."
How the ground truth for the training set was established:
- Not Applicable. There is no training set for an AI/machine learning model.

In summary, the document states:

Clinical Performance: "Not applicable. Clinical testing was not provided to demonstrate the substantial equivalence of the Back on Trac (BOTGEN1) and Cervi-Trac." (Page 12)
Non-Clinical Performance: The devices underwent "100% performance testing and Quality Assurance inspection" by the manufacturer, and "Performance testing...demonstrated the design, operational and functional parameters and safety features met the established specifications for each device and demonstrate performance substantial that is equivalent to the predicate device." (Page 12).
The device was evaluated and tested by independent certified testing facilities in conformance with various consensus standards related to electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), usability (IEC 60601-1-6, IEC 62366-1), risk management (ISO 14971), and biocompatibility (IEC 10993). (Page 13)

This 510(k) clearance is based on the comparison to a legally marketed predicate device (Chattanooga Group's Triton/Tru-Trac/TX/Triton DTS Traction, K053223) and compliance with relevant safety and performance standards for mechanical devices, not on the demonstration of clinical efficacy through formal acceptance criteria and studies with human data.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".

February 22, 2024

Ergo-Flex Technologies, LLC % M. Heinrich President Texas Applied Biomedical Services 12101 Cullen Blve. Suite A Houston, Texas 77047

Re: K214037

Trade/Device Name: Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac Regulation Number: 21 CFR 890.5900 Regulation Name: Power traction equipment Regulatory Class: Class II Product Code: ITH, ILZ, IRT, IRO Dated: February 7, 2024 Received: February 7, 2024

Dear M. Heinrich:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerelv.

Amber T. Ballard -S

Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological

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and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K214037

Device Name: Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac

Indications for Use (Describe)

Back on Trac

The Back on Trac (BOTGEN1) is intended for use to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, shoulder)". The device may be used to manage and reduce pain associated with the following conditions:

facet syndrome, ●
herniated disc, ●
. protruding disc,
extruded disc,
sciatica,
spondylosis (degenerative disc disease & facet syndrome),
joint pain. ●

Cervi-Trac

The Cervi-Trac is intended for use as an accessory to the Back on Trac (BOTGEN1) to relieve pressures on structures that may be causing pain of skeletal or muscular origin. The Cervi-Trac accessory focuses specifically on the cervical region.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510K Summary

1. GENERAL INFORMATION

Date Prepared:Device Generic Name:	February 22, 2024Power Traction Equipment
Trade Name:	Ergo-Flex Technologies Back on Trac(BOTGEN1) and Cervi-Trac
Device Classification:	Class II, PerformanceStandards21CFR Part 890.5900 - Power Traction Equipment
Product Code:Additional Product Codes:	ITHILZ, IRT, IRO
Applicant Name / Address:	Ergo-Flex Technologies, LLC13622 Poplar CircleSuite 403Conroe, TX 77304Telephone: 936-588-5510
Key Contact:	M. Joyce HeinrichTexas Applied Biomedical Services, Inc.12101 Cullen Blvd, Suite AHouston, Texas 77047Telephone: 281-389-0531Email: Tabsii2@comcast.net

510(k) Number: K214037

2. Device Description

Ergo-Flex Back on Trac System:

510K SUMMARY

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The Back on Trac (BOTGEN1) is intended for use in professional healthcare facilities, to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, shoulder). The device may be used to \ manage and reduce pain associated with the following conditions: facet syndrome, herniated disc, protruding disc, extruded disc, sciatica, spondylosis (degenerative disc disease & facet syndrome), and joint pain.

The (BOTGEN1) is comprised of a reclinable therapeutic cushioned chair with back support portion and a second lower back, upper and lower leg support section that is movable in an axial direction with respect to the back support section and is also arcuately movable about a pivot axis that is perpendicular to the axial direction. The chair includes remotely controlled linear actuators to control the relative movement of the different sections of the device.

Image /page/6/Picture/4 description: The image shows a black chair with a unique design. The chair has a padded seat and backrest, as well as armrests. The chair is made of black leather and has a metal frame. The chair appears to be designed for comfort and support.

Figure 1. Ergo-Flex Back on Trac (BOTGEN1)

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Ergo-Flex Cervi-Trac:

The Cervi-Trac (CT), as shown in Figure 2, is an accessory to the Back on Trac (BOTGEN1) that focuses specifically on the cervical region. The patient is not restrained by the Back on Trac arm bolsters, therefore lumbar traction is not activated by the Cervi-Trac during this therapy.

Image /page/7/Picture/3 description: The image shows a black chiropractic table with a headpiece and adjustable straps. The headpiece is positioned at the top of the table and has a vertical adjustment mechanism. The adjustable straps are located on either side of the table and have triangular supports at the ends. The table is made of black leather and has a smooth surface.

Figure 2. Cervi-Trac (attached to Back on Trac)

3. Indications for Use

The Back on Trac (BOTGEN1) and Cervi-Trac Systems are intended for use in professional healthcare facilities, to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, shoulder).

Back on Trac (BOTGEN1)

facet syndrome,
herniated disc,
protruding disc,
extruded disc,
sciatica,
spondylosis (degenerative disc disease & facet syndrome), ●

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. joint pain.

Cervi-Trac

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4. Predicate Devices

The Back on Trac (BOTGEN1) and Cervi-Trac Systems are substantially equivalent to other power traction devices that have been previously cleared by the FDA via the 510K process.

510(k) Number	Predicate Device Name	Manufacturer
K053223	Triton/Tru-Trac/TX/Triton DTS Traction	Chattanooga Group

5. Summary of the Technical Characteristics of the Subject Device to the Predicate Device.

The Indications for Use Statement listed for the Back on Trac (BOTGEN1) and Cervi-Trac accessory are similar to the indications for use of the predicate device. The technical characteristics and operational parameters of the Back on Trac (BOTGEN1) and Cervi- Trac and the predicate devices are substantially equivalent. Table 1 shows a comparison of the primary technological characteristics and operational parameters of the Back on Trac (BOTGEN1) and Cervi-Trac to the referenced predicate devices.

Table 1.

Comparison of the IFU and Technical Specifications and Performance Characteristics of the Back on Trac (BOTGEN1) and Cervi-Trac to the Triton/Tru-Trac/TX/Triton DTS Traction

Parameter	Back on Trac (BOTGEN1)/ Cervi-Trac	Triton/Tru-Trac/TX/Triton DTS Traction	Similarities andDifferences
K Number	K214037	K053223	N/A
Intended Use	Prescription useonly	Prescription use only	Same
Environment	Professionalhealthcarefacilities, clinicsand/ orhospitals	Professional healthcarefacilities, clinics and/ orhospitals	Same
Use	The Back on Trac (BOTGEN1) andCervi- Trac Systems are intendedfor use in professional healthcarefacilities, to relieve pressures onstructures that may be causing painof skeletal or muscular origin(cervical, thoracic, lumbar, hip,shoulder).Back on Trac (BOTGEN1)The Back on Trac is intended foruse to relieve pressures onstructures that may be causing	The Triton/ Tru-Trac/TX/TritonDTS Traction devices providetraction and mobilizationof skeletal structures and skeletalmuscles.The Triton/ Tru-Trac/TX/Triton DTSTraction devices provide atreatment in static, intermittent,progressive, regressive and cyclingdistraction forces to relievepressures on structures that may becausing pain of skeletal or muscular	Similarities:The Back on Trac(BOTGEN1),Cervi-Trac andthe predicaterelieve pressureson structures thatmay be causingpain of skeletalor muscularorigin (cervical,thoracic, lumbar,hip, shoulder).
	pain of skeletal or muscularorigin (cervical, thoracic,lumbar, hip, shoulder)". Thedevice may be used to manageand reduce pain associated withthe following conditions:• facet syndrome,• herniated disc,• protruding disc,• extruded disc,• sciatica,• spondylosis(degenerative discdisease & facetsyndrome),• joint pain.Vibration and heat are availableoptions that can be utilized withthe Back on Trac at thediscretion of the healthcareprofessional. When activated, thevibration mode can providemuscle relaxation and temporaryrelief of minor aches and pains.The heat mode, when activated,can provide temporary relief ofminor aches and pains. The localwarmth temporarily stimulateslocal blood circulation in yourlower back.Cervi-TracThe Cervi-Trac is intended foruse as an accessory to the Backon Trac (BOTGEN1) to relievepressures on structures thatmay be causing pain of skeletalor muscular origin. The Cervi-Trac accessory focusesspecifically on the cervicalregion.	origin (cervical, thoracic, lumbar,hip, wrist, shoulder). Therapeuticdistraction can be applied in a varietyof programmable patterns, cyclesand functions.The Triton/ Tru-Trac/ TX/ TritonDTS 'Traction devices with theoptional EMG (a.k.a. sEMG)biofeedback feature may be used torelieve peripheral radiation/sciaticaand pain associated with:• Protruding discs• Bulging discs• Herniated discs• Degenerative disc disease• Posterior facet syndrome• Acute facet problems• Radicular pain• Prolapsed disc• Spinal root impingement• Degenerative joint disease• Facet syndrome• Compressionfractures• Joint pain• Discogenic painEMG (a.k.a. sEMG)Determination of theactivation magnitude andtiming of muscles for:a) retraining of muscleactivationb) coordination of muscleactivation• Determination of theforce produced bymuscle for control andmaintenance of musclecontractions.• Relaxation muscletraining• Muscle re-education	Differences:The Back on Trachas optionalVibration andHeat modes.The Back on Tracdoes not includebiofeedbackoption.
Treatment Areas	Cervical /Lumbar /Thoracic / Hip /Wrist / Shoulder	Cervical / Lumbar /Thoracic / Hip / Wrist /Shoulder	Same
ElectricalClassificationand Type	Class IIType B	Not Publicly Available	UNK
Electrical SafetyConsensusStandard	IEC 60601-1:2005	UL 60601-1:2003	Same
EMC ConsensusStandard	IEC 60601-1-2	IEC 60601-1-2:2001	Same
UsabilityConsensusStandard	IEC 60601-1-6	Not Publicly Available	UNK
Biocompatibility	IEC 10993-5:2009	Not Publicly Available	UNK
TractionMechanism	Electromechanical	Electromechanical	Same
ActuationMechanism	Electromechanical	Not Publicly Available	UNK
Traction Force	Min and Max traction force: BOT =0 - 91lbs.Cervi-Trac= 0 - 34.5 lbs.	Not Publicly Available	UNK
OperationalComponents	Software controlled actuator fortraction and flexion	Software controlled traction	Same
Traction Speed	Continuous, Adjustable(~0.25"/second)	Not Publicly Available	UNK
Treatment Time	5 - 15 minutes	Not Publicly Available	Similar
Therapy Mode	Continuous	Not Publicly Available	UNK
Power Supply	110-120V (60Hz)220-240V (50Hz)	Not Publicly Available	UNK
Battery Backup	Yes	N/A	Back on Trac has a batterybackup should there be a powerfailure.
EnvironmentalConditions(Temperature,relative humidity,air pressure)	Work: +10° to 40° C, 30 to75% non-condensing, 700-1060hPa storage: +5 to 45° C, notexceeding 75% non-condensing,700-1060 hPatransport: +10 to 45° C,20 to 95% non-condensing,700-1060 hPa	Not Publicly Available	UNK

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510K Notification — K214037

Ergo-Flex Technologies. LLC Back on Trac (BOTGEN1), Cervi-Trac

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510K Notification — K214037

Ergo-Flex Technologies. LLCC
Back on Trac (BOTGEN1), Cervi-Trac

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6. Testing

Clinical Performance:

Not applicable. Clinical testing was not provided to demonstrate the substantial equivalence of the Back on Trac (BOTGEN1) and Cervi-Trac.

Non-Clinical Performance:

The Back on Trac (BOTGEN1) and Cervi-Trac devices undergo 100% performance testing and Quality Assurance inspection by Ergo-Flex Technologies in accordance with the Company's written standard operating procedures (SOP) prior to release to inventory. All Quality Assurance and performance test documentation is maintained in the Device History Record at the Corporate site as required by 21 CFR 820.184.

Performance testing on the Back on Trac (BOTGEN1) and Cervi-Trac Systems demonstrated the design, operational and functional parameters and safety features met the established specifications for each device and demonstrate performance substantial that is equivalent to the predicate device.

The Back on Trac (BOTGEN1) System has been evaluated and tested by independent certified testing facilities in conformance the following consensus standards:

FDA RecognitionNumber	Standard	Description
19-46	IEC 60601-1:2005 +A1:2012	Medical electrical equipment - Part 1:General requirements for basic safety andessential performance
19-8	IEC 60601-1-2:2015	Medical electrical equipment - Part 1-2:General requirements for safety - Collateralstandard: Electromagnetic Compatibility
5-89	IEC 60601-1-6:2010+ A1:2013	Medical electrical equipment - Part1:General requirements for safety Collateralstandard: Usability
5-40	ISO 14971:2007	Medical Devices - Application of RiskManagement to Medical Devices
5-114	IEC 62366-1:2015	Medical Devices - Part 1: Application ofusability engineering to medical devices
19-29	ANSI C63.27	ANSI for Evaluation of Wireless Coexistence
	IEC 10993:2017	Biocompatibility

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7. Conclusions

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device may have the same intended use and different technological characteristics if they can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.

Pursuant to the testing and comparison to the predicate devices, the Ergo Flex Technologies, LLC Back on Trac (BOTGEN1) and Cervi-Trac devices have the same and/or equivalent intended uses, with similar technical, functional and performance characteristics as the predicate devices listed above.

The Back on Trac (BOTGEN1) and Cervi-Trac Systems perform as intended and do not raise any new safety or efficacy issues.

Regulation Number and Section

§ 890.5900 Power traction equipment.

(a)
Identification. Powered traction equipment consists of powered devices intended for medical purposes for use in conjunction with traction accessories, such as belts and harnesses, to exert therapeutic pulling forces on the patient's body.(b)
Classification. Class II (performance standards).