TM-400

K081247 · Ito Co., Ltd. · ITH · Aug 25, 2008 · Physical Medicine

Device Facts

• Record ID: K081247
• Device Name: TM-400
• Applicant: Ito Co., Ltd.
• Product Code: ITH · Physical Medicine
• Decision Date: Aug 25, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5900
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TM-400 device is intended to be used by medical professionals and facilities including in-patient and out-patient hospitals and clinics, chiropractors, physical therapists, sports rehabilitation clinics, occupational therapists, and other qualified users according to the detailed indications for use. Sale of the TM-400 is restricted to a licensed physician or licensed practitioner, or on the order or prescription of a physician or licensed practitioner.

Device Story

TM-400 is a software-controlled electro-mechanical powered traction unit used in clinical settings (hospitals, clinics, rehab centers) by medical professionals. Device applies static, intermittent, or cyclical traction forces to skeletal/muscular structures via a cable hook and harness system. Features include automatic force calibration, five selectable traction speeds, eight traction modes, and a remote patient-controlled shutoff switch. Internal memory stores up to 30 treatment patterns. High-visibility LCD screen displays treatment parameters. Clinicians use the device to relieve pressure on spinal/joint structures, reduce pain, and improve mobility. Benefits include non-invasive pain relief and controlled mobilization of skeletal structures.

Clinical Evidence

Bench testing only. Verification and validation testing conducted on final production units to confirm performance specifications and safety. Compliance with UL60601-1 (electrical safety) and IEC60601-1-2 (electromagnetic compatibility) verified by TUV.

Technological Characteristics

Powered electro-mechanical traction system. Features: LCD interface, remote patient shutoff, internal memory for 30 patterns, automatic force calibration. Connectivity: Standalone unit. Software: Embedded, software-controlled. Standards: UL60601-1, IEC60601-1-2.

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, wrist, shoulder). Treats conditions including disc herniation/degeneration, facet syndrome, muscle spasms, spinal root impingement, pinched nerves, compression fractures, and hypomobility. Provides static, intermittent, progressive, regressive, and cyclical distraction forces.

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

• TM-300 Traction System (K992545)
• TX Traction (K053223)

Submission Summary (Full Text)

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# K081247 (pg1/3)

MANUFACTURERS & EXPORTERS established in 1916 TOYOTAMA-MINAMI, NERIMA-KU, TOKYO, 176-0014 JAPAN

AUG 25 2008

# 510(k) Summary

# TM-400

# Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination

| Submitter Name: | ITO CO., LTD. |
|------------------------|---------------------------------------------------|
| | 3-3-3 TOYOTAMA-MINAMI, NERIMA-KU |
| | TOKYO, 176-0014 JAPAN |
| | TEL: [phone] |
| | FAX: [phone] |
| Contact Name: | KENNETH L. BLOCK, RAC |
| Date Prepared: | August 15, 2008 |
| Proprietary Name: | TM-400 |
| Common Name: | Powered Traction Device |
| Classification Number: | 21 CFR 890.5900 |
| Class: | II |
| Predicate Devices: | K992545 - TM-300 Traction System (ITO. CO., LTD.) |
| | K053223 - TX Traction (CHATTANOOGA GROUP) |

#### Device Description:

The TM-400 is a simple to use powered traction unit that offers static, intermittent, and cycle traction with user-definable hold, rest and treatment times. The unit consists of a software-controlled electro-mechanical traction system. The physical characteristics of the TM-400 are substantially equivalent to the predicate traction devices including size, weight, materials of construction, and user interface. In addition, the unit has incorporated similar features as the predicate devices such as:

- ア Automatic calibration of traction force
- > An internal memory that stores up to 30 treatment patterns
- A Traction speed selectable from five preset values
- 公 Eight traction modes
- A Remote patient-controlled treatment shutoff switch
- ﺮ Large and high-visibility LCD screen

Section 6

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The TM-400 traction device operates by attaching the cable hook to a harness accessory, which is in turn attached to the patient treatment area, for traction and mobilization of skeletal muscles according to the detailed indications of use. Detailed comparison of specific TM-400 features and characteristics to the predicate devices is contained in Section 8 of this submission.

#### Intended Use:

The TM-400 device is intended to be used by medical professionals and facilities including in-patient and out-patient hospitals and clinics, chiropractors, physical therapists, sports rehabilitation clinics, occupational therapists, and other qualified users according to the detailed indications for use. Sale of the TM-400 is restricted to a licensed physician or licensed practitioner, or on the order or prescription of a physician or licensed practitioner.

#### Indications for Use:

Use of the TM-400 powered traction device is indicated for the following:

- Providing standard therapeutic and custom user-defined treatments in static, intermittent, . progressive, regressive, cyclical and combination distraction forces to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, wrist, shoulder).
- . Providing traction and mobilization of skeletal structures and skeletal muscles.
- Relieving peripheral radiation / sciatica and pain associated with: .
- Discs:
- > Protruding, bulging, herniated and prolapsed discs
- > Degenerative disc disease
- > Discogenic pain

Facets:

- > Facet syndrome
- > Posterior facet syndrome
- � Acute facet problem

#### Muscles & Joints:

- > Muscle pain and spasms
- > Degenerative joint disease

#### Spinal Structures:

- > Spinal root impingement
- > Pinched nerves
- > Compression fractures

Pain:

> Back, lower back, neck, joint, sciatic and radicular pain

Mobility & Flexibility:

- > Hypomobility
- > Limited spinal and joint flexibility

#### Cited Standards to Determine Substantially Equivalence:

Testing was carried out to assure compliance to FDA recognized electrical safety standards. ITO CO., LTD was issued a certificate of compliance to the UL60601-1 standards by TUV, which appears in Section 13 of this submission. In addition, ITO CO., I.TD was issued an Attestation of Conformity for the TM-400 in regard to the 11:C60601-1-2 standards for electromagnetic compatibility by 1'UV, which appears in Section 13 of this submission.

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#### Non-Clinical Testing:

Non-clinical verification and validation testing was conducted on final TM-400 production units, and the results of such testing appear in Section 12 and Section 14 of this submission.

#### Truthful and Accuracy Statement:

Signed by a corporate management representative of the required statement attesting to the truthfulness and accuracy of the information contained in Section 7 of this submission.

#### Further Information:

Please contact the following individual to request any further information regarding this submission:

Kenneth L. Block, RAC Official Correspondent (ITO CO., LTD.) Ken Block Consulting 1201 Richardson Dr. Suite 140 Richardson, TX 75080 TEL: [phone] FAX: [phone] EMAIL: [e-mail]

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 5 2008

ITO Co., Ltd. % Ken Block Consulting Mr. Kenneth L. Block, RAC 1201 Richardson Drive, Suite 140 Richardson, Texas 75080

Re: K081247

Trade/Device Name: TM-400 Regulation Number: 21 CFR 890.5900 Regulation Name: Power traction equipment Regulatory Class: II Product Code: ITH Dated: July 7, 2008 Received: July 8, 2008

Dear Mr. Block:

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. Iisting 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 - Mr. Kenneth L. Block, RAC

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Arsistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M. Millerson

- Mark N. Melkerson 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 (if known): K08 1247 (pg 1/ 1)

## Device Name: TM-400

## Indications for Use:

Use of the TM-400 powered traction device is indicated for the following:

- Providing standard therapeutic and custom user-defined treatments in static, intermittent, . progressive, regressive, cyclical and combination distraction forces to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, wrist, shoulder).
- Providing traction and mobilization of skeletal structures and skeletal muscles. .
- . Relieving peripheral radiation / sciatica and pain associated with:

Discs:

- A Protruding, bulging, herniated and prolapsed discs
- A Degenerative disc disease
- A Discogenic pain

Facets:

- A Facet syndrome
- A Posterior facet syndrome
- Acute facet problem A

Muscles & Joints:

- Muscle pain and spasms A
- Degenerative joint disease A

Spinal Structures:

- Spinal root impingement A
- a Pinched nerves
- A Compression fractures

## Pain:

- Back, lower back, neck, joint, sciatic and radicular pain A
Mobility & Flexibility:

- > Hypomobility
- > Limited spinal and joint flexibility

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDHR, Office of Device Evaluation (ODE)

Raubare Buchenu
(Division Sign Off)

Division of Gener Restorative. and Neurological Devices

510(k) Number K081247

TM-400