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

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

AI/ML Overview

The provided text describes the TM-400 powered traction device and its intended use, but it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The document is a 510(k) summary for a medical device submitted to the FDA, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results against acceptance criteria.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and performance study results based solely on the provided text.

Here's why and what information would typically be expected for such a request:

Acceptance Criteria and Reported Device Performance: This would require a table outlining quantitative or qualitative performance targets (e.g., accuracy of traction force, speed consistency) and the actual validated performance values from testing. The document states "Testing was carried out to assure compliance to FDA recognized electrical safety standards," and "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." However, these sections are not provided in the input, so the specific acceptance criteria and performance data are missing.
Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone study, ground truth type, training set size, and training set ground truth establishment: These are all elements typically found in detailed clinical or non-clinical performance studies, often in sections beyond a 510(k) summary. The provided text only mentions "non-clinical verification and validation testing." For a powered traction device, these studies would likely focus on mechanical performance, safety, and potentially effectiveness if a clinical study were performed (though typically not required for substantial equivalence).

In summary, the provided document focuses on:

Device description and features.
Intended use and indications for use.
Comparison to predicate devices (K992545 and K053223).
Compliance with electrical safety (UL60601-1) and electromagnetic compatibility (IEC60601-1-2) standards.
The FDA's decision of substantial equivalence.

It does not disclose the detailed results of non-clinical verification and validation testing or any clinical studies that would address the acceptance criteria and performance metrics you've requested.

Summary

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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: (+81) 3-3994-4619
	FAX: (+81) 3-3994-8384
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:

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

{1}------------------------------------------------

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.

{2}------------------------------------------------

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: 972-480-9554 FAX: 972-767-4325 EMAIL: ken@kenblockconsulting.com

{3}------------------------------------------------

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.

{4}------------------------------------------------

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 (240) 276-0120. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 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

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).