TRITON/TRU-TRAC/TX TRACTION DEVICES

K051938 · Chattanooga Group · ITH · Sep 21, 2005 · Physical Medicine

Device Facts

• Record ID: K051938
• Device Name: TRITON/TRU-TRAC/TX TRACTION DEVICES
• Applicant: Chattanooga Group
• Product Code: ITH · Physical Medicine
• Decision Date: Sep 21, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5900
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Triton/Tru-Trac/TX traction devices provide traction and mobilization of skeletal structures and skeletal muscles. The Triton/Tru-Trac/TX traction devices provide a treatment in static, intermittent, progressive, regressive and cycling distraction forces to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, knee). Traction can be applied in a variety of programmable patterns, cycles and functions. The Triton/Tru-Trac/TX traction devices may be used to relieve peripheral radiation/sciatica and pain associated with: - Protruding discs - Bulging discs - Herniated discs - Degenerative disc disease - Posterior facet syndrome - Acute facet problems - Radicular pain - Prolapsed discs - Spinal root impingement - Hypomobility - Degenerative joint disease - Facet syndrome - Compressions fractures - Joint pain - Discogenic pain. The Triton/Tru-Trac/TX traction devices achieve these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.

Device Story

Triton/Tru-Trac/TX traction devices provide mechanical traction and mobilization of skeletal structures and muscles; used in clinical settings by healthcare professionals. Device applies static, intermittent, progressive, regressive, and cycling distraction forces to decompress intervertebral discs and relieve pressure on structures causing pain. Input parameters include programmable traction patterns, cycles, and force levels. Output is controlled mechanical distraction to the patient. Benefits include relief of pain associated with disc herniation, facet syndrome, and spinal root impingement through unloading and positioning. Clinicians use device output to manage musculoskeletal and spinal conditions.

Clinical Evidence

Bench testing only.

Technological Characteristics

Powered traction equipment (21 CFR 890.5900). Provides static, intermittent, progressive, regressive, and cycling distraction forces. Programmable control interface for traction patterns and cycles. Class II device.

Indications for Use

Indicated for patients requiring traction and mobilization of skeletal structures and muscles to relieve pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, knee) and peripheral radiation/sciatica associated with disc-related conditions, facet syndromes, joint pain, and spinal root impingement.

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.

Submission Summary (Full Text)

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SEP 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cheryl L. Bagwell Director of Regulatory Chattanooga Group 4717 Adams Road Hixson, TN 37343

Re: K051938

Trade/Device Name: Triton/Tru-Trac/TX Traction Regulation Number: 21 CFR 890.5900 Regulation Name: Powered traction equipment Regulatory Class: Class II Product Code: ITH Dated: July 15, 2005 Received: July 20, 2005

Dear Ms. Bagwell:

We have reviewed your Section 510(k) premarket notification of intent to market the device in indication we nave reviewed your Soctor 9 ro(s) premieries is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosulty to regarly manative profithe Medical Device Ameridments, or to
commerce prior to May 28, 1976, the enactment date of the Medical Device Brya commerce prior to May 20, 1770, the chance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval of the Act. For and Cosment Act (Act) that do not require special controls provisions of the Act. The You may, merciole, market the do Act include requirements for annual registration, listing of general controls provisions of the rice, 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 If your device is classifica (soc above) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major and control lit may be subject to such additional volusions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ourcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA 3 issualled of a cases of a certains of the requirements of the Act that I DA has made a decemmation administered by other Federal agencies. You must of ally recetal statutes and regulations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as sets CrK Fatt 807), labeling (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Ms. Cheryl Bagwell

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begill marketing your avvalence of your device to a legally
premarket notification. The FDA finding of substantial equipales of the permits vo premarket notification. The FDA inding of substantal. Poplar 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
rst lead If you desire specific advice for your do vice of our of the regulation entitled, the regulation entitled, the leavery of the may obtain contact the Office of Compliation at (240) 210 of PR Part 807.97). You may obtain "Misbranding by relerence to prematics notified.com of the Act from the Division of Small other general information on your responsionner Assistance at its toll-free number [phone] or Manufacturers, International and Consumer Prositiation aroved corport/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Sis Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KOS1938

ન્દ્ર

-

510(k) Number (if known): K Triton/Tru-Trac/TX Traction Device Name:

Indications for Use:

The Triton/Tru-Trac/TX traction devices provide traction and mobilization of skeletal structures and skeletal muscles.

The Triton/Tru-Trac/TX traction devices provide a treatment in static, intermittent, The Trion Fra Tractive and cycling distraction forces to relieve pressures on structures progressive, rogress round of skeletal or muscular origin (cervical, thoracic, lumbar, hip, that may be causing pain of existraction can be applied in a variety of programmable patterns, cycles and functions.

The Triton/Tru-Trac/TX traction devices may be used to relieve peripheral radiation/sciatica and pain associated with:

- > Protruding discs
- > Bulging discs
- > Herniated discs
- > Degenerative disc disease
- > Posterior facet syndrome
- > Acute facet problems
- > Radicular pain
- > Prolapsed discs
- >> Spinal root impingement
- > Hypomobility
- > Degenerative joint disease
- > Facet syndrome
- > Compressions fractures
- > Joint pain
- > Discogenic pain

The Triton/Tru-Trac/TX traction devices achieve these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.

| Prescription Use | AND/OR | Over-The-Counter Use |
|-----------------------------|--------|------------------------|
| (Part 21 CFR 801 Subpart D) | | (21 CFR 801 Subpart C) |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative,

and Neurological Devices

| 510(k) Number | K051938 |
|---------------|---------|
|---------------|---------|

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