EXTENTRAC ELITE

K031996 · Advanced Back Technologies · ITH · Jul 23, 2004 · Physical Medicine

Device Facts

• Record ID: K031996
• Device Name: EXTENTRAC ELITE
• Applicant: Advanced Back Technologies
• Product Code: ITH · Physical Medicine
• Decision Date: Jul 23, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 890.5900
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Extentrac consists of rotating patient platform and two separate traction force generators. It is designed to exert a therapeutic distractive force on the patient's spine through 'gravitational' or 'motorized' means as required to relieve pressure on anatomical structures that may be causing pain. It produces the forces and positions required to cause decompression of the intervertrebral discs, that is, unloading due to distraction and positioning. Federal law restricts this device to sale on or by the order of a licensed practitioner.

Device Story

Extentrac Elite is a multifunctional, powered traction table for spinal decompression. Device uses hydraulic actuators to provide horizontal motorized traction and vertical gravitational traction. Patient is positioned in flexion, axial, extension, or lateral flexion. Input data includes positioning via sensing potentiometers and force monitoring via load cells. PLC coordinates movement and traction sequences. Practitioner controls device via remote keypad, flat screen monitor, mouse, and control panels. Patients may operate limited gravity-based rotation and lumbar extension via handgrips, though power traction features are restricted to practitioner use. Output includes controlled distractive forces to decompress intervertebral discs, aiming to relieve pain. Used in clinical settings by practitioners.

Clinical Evidence

Bench testing only. Device certified for compliance with IEC 601-1-1 (Electrical Medical Equipment Safety) and IEC 601-1-2 (Electromagnetic Compatibility) by Underwriters Laboratories (UL file E246377). No clinical trial data provided.

Technological Characteristics

Multifunctional traction table; hydraulic actuators for movement and force generation; PLC-controlled; positioning sensing potentiometers; load cells for force monitoring. Dimensions: 80-89 inches long, 35 inches wide, 84-92 inches height. Max weight capacity 300 lbs. Connectivity: practitioner-operated via remote, monitor, and control panels. Safety: UL certified per IEC 601-1-1 and IEC 601-1-2.

Indications for Use

Indicated for patients with localized low back pain or peripheral radiation/sciatica due to protruding or herniated intervertebral discs, acute facet problems, or degenerative disc disease. Prescription use only.

Regulatory Classification

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.

Predicate Devices

• Extentrac (K890021)
• Vax-D Therapeutic table (K951622)
• 3D ActiveTrac (K001712)
• Galaxy 900 HS chiropractic table
• Galaxy McManis Mobile-Trac Hydraulically-Controlled Table

Submission Summary (Full Text)

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K031996

## ABT Advanced Back Technologies, Inc.

| 510(K) Summary | JUL 2 3 2004 |
|----------------|--------------|
|----------------|--------------|

| Company Name: | Advanced Back Technologies, Inc.<br>227 Jackson Avenue<br>Syosset, NY 11791 |
|----------------------|------------------------------------------------------------------------------------------|
| Telephone: | 516-364-1717 |
| Fax: | 516-364-1998 |
| E-mail | [e-mail] |
| Contact Person: | David Cuccia, D.C.<br>516-364-1717<br>Fax: [phone]<br>E-Mail: [e-mail] |
| Date Prepared: | July 13, 2004 |
| Trade Name: | Extentrac Elite |
| Common Name: | Traction Equipment, Powered |
| Class and Reference: | Class II (21 CFR SECTION 890.5900) |
| Product Code: | 89ITH |
| Panel Code: | 87OR |

#### Substantial Equivalent to the following Predicate Devices:

- Extentrac, 510(k) Number-K890021 .
- Vax-D Therapeutic table K951622 .
- 3D ActiveTrac, 510(k) number K001712 .
- . Galaxy 900 HS chiropractic table [Class 1 exempt]
- . Galaxy McManis Mobile-Trac Hydraulically-Controlled Table (see page 12).

#### Device Description:

The Extentrac Elite is a multifunctional traction table that incorporates two traction force generators to supply 'powered' traction during horizontal patient positioning while offering 'gravitational' traction and selective patient positioning during treatment into flexion, axial, extension, and lateral flexion.

The device consists of two main assemblies:

- 1. A rectangular base platform, which provides the support for the rotating patient upper support platform.
- 2. A rotating cushioned patient platform (upper top section) consisting of three separate support cushions attached to the sub-support frame. It is pivotally connected at its approximate center of gravity with the top end of the rectangular base platform. This provides the rotational capability to effect vertical gravity

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# ABT Advanced Back Technologies, Inc.

treatment protocols and positions the rotating patient platform assembly in the horizontal plane for administrating decompression /distraction protocols utilizing the power features in the lumbar and leg assembly respectively.

The rotating patient platform assembly consists of 1. Underarm/supports with integral handgrips containing the patient controls, 2. Lumbar back support cushion assembly (convex shaped), 3. Leg Support Assembly, 4. Upper Torso Support Cushion Assembly, 5. Overhead Rear Gripping Bar.

This patient platform and the attached assemblies measures 80 inches long with the power traction leg assembly un-extended and 89 inches fully extended. The manual leg assembly range is 12 inches. The total vertical retracted height of the device is 84 inches and the height extended is 92 inches. The width of the rectangular base is 35 inches.

Two hydraulic cylinders internal to the right and left side telescoping columns on the rectangular base platform raise and lower the height of the moving assembly by 12 inches.

The leg assembly distractive range is 9 inches (power) The lumbar assembly distractive range is 6 inches (power)

Maximum weight capacity is 300 lbs.

All of the devices movements are powered by hydraulic actuators. The actuators position the device and all assemblies with the use of positioning sensing potentiometers for exact input of data to the PLC to coordinate and sequence all of the devices movements. The traction/distractive forces applied are through hydraulic driven assemblies with load cells to accurately monitor pounds of force applied throughout the treatment cycle.

The device is controlled by the practitioner with following:

- 1. Remote Control Keypad
- 2. Computer Flat Screen Monitor and Mouse
- 3. Control Bar Switches on Leg Assembly
- 4. Lumbar Side Control Panel
- 5. Power Control Panel

Patients may control gravity traction vertical procedures by utilizing handgrip switches or overhead rear gripping bar switches. These switches control the patient platform rotation and the lumbar extension of the lumbar cushion.

Patients do not have the ability to utilize any of the power traction features of either the lumbar or leg assemblies. Operation of the patient switches may be deactivated by the practitioner at any time.

The level of device risk has been evaluated to be minimum, as numerous safety features have effectively mitigated any hazards.

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## ABT Advanced Back Technologies, Inc.

### Intended Use:

Extentrac consists of rotating patient platform and two separate traction force generators. It is designed to exert a therapeutic distractive force on the patient's spine through 'gravitational' or 'motorized' means as required to relieve pressure on anatomical structures that may be causing pain. It produces the forces and positions required to cause decompression of the intervertrebral discs, that is, unloading due to distraction and positioning.

#### Indications for Use:

Conditions that may be treated include localized low back pain or peripheral radiation / sciatica due to:

- Protruding or herniated intervertebral discs .
- Acute facet problems .
- . Degenerative disc disease

Federal law restricts this device to sale on or by the order of a licensed practitioner.

### Device Testing:

Following initial submission of the 510(k) cited above, the ABT Extentrac Elite device was tested and certified to be in compliance with IEC 601-1-1 Electrical Medical Equipment. General Requirements for Safety, and IEC 601-1-2 Electromagnetic Compatibility, per Underwriters Laboratories (UL) file E246377.

Revisions of the device required to meet UL certifications involved minor adjustments to mechanical and electrical configuration; they were primarily related to shielding to meet the EMC standard. None of the changes impacted the Substantial Equivalence or Safety and Effectiveness of the device as enumerated in the 510(k).

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 3 2004

David F. Cuccia President Advanced Back Technologies, Inc. 227 Jackson Avenue Syosset, New York 11791

Re: K031996

Trade/Device Name: Extentrac Elite Regulation Number: 21 CFR 890.5900 Regulation Name: Powered traction equipment Regulatory Class: II Product Code: ITH Dated: June 11, 2004 Received: June 16, 2004

Dear Mr.Cuccia :

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

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Page 2 - David F. Cuccia

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 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
Mark N Millmann

Celia M. Witten, Ph.D., M.D. 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

510(k) Number: K031996

Device Name: Extentrac Elite

Indications for Use:

Conditions that may be treated include localized low back pain or peripheral radiation / sciatica due to:

- Protruding or herniated intervertebral discs .
- Acute facet problems .

ﺮ ﻣﺮ

- Degenerative disc disease .
Federal law restricts this device to sale on or by the order of a licensed practitioner.

Prescription Use X (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Milken

Division of General, Restorative, and Neurological Devices

K031996

510(k) Nu

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