LEGACY-500

K111588 · Mt Tables, LLC · JFB · Oct 26, 2012 · Physical Medicine

Device Facts

• Record ID: K111588
• Device Name: LEGACY-500
• Applicant: Mt Tables, LLC
• Product Code: JFB · Physical Medicine
• Decision Date: Oct 26, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5880
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use is to provide muscle relaxation therapy by delivering a soothing massage.

Device Story

Legacy-500 is an electrically powered, motorized physical therapy table; provides muscle relaxation therapy via soothing massage. Device features three 6-inch diameter rollers traveling along back area; rollers rotate clockwise or counter-clockwise; roller pressure adjustable (levels 1-6); roller height adjustable up to 3 inches above table surface. User/patient operates via control panel; timer (1-30 minutes) manages treatment duration and acts as safety shut-off. Patient lies on vinyl-upholstered table top. Output is mechanical massage; healthcare provider uses output to facilitate muscle relaxation. Benefits include localized or full-back muscle tension release.

Clinical Evidence

No clinical data. Substantial equivalence based on bench testing and comparison of technological characteristics to predicate devices.

Technological Characteristics

Electrically powered, motorized physical therapy table. Features: three 6-inch diameter massage rollers, steel roller carriage, vinyl upholstery. Adjustable roller pressure (6 levels) and height (3 inches). Electrical components include motors and timer-based safety shut-off. Control panel located at head end. No software-based algorithms; operation is electromechanical.

Indications for Use

Indicated for individuals requiring muscle relaxation therapy via soothing massage.

Regulatory Classification

Identification

A multi-function physical therapy table is a device intended for medical purposes that consists of a motorized table equipped to provide patients with heat, traction, and muscle relaxation therapy.

Predicate Devices

• Magnum (K010252)
• Quantum 400 (K002390)
• Quest IST (K993461)

Submission Summary (Full Text)

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KIII1588 PAGE 1 OF

## 510(k) Summary as Required by 21 CFR 807.92

| Submitter: | MT Tables, LLC |
|--------------------------|--------------------------------------------------------|
| | 15 W. Mill Street |
| | Aurora, MO 65605 |
| Contact Person: | Milburn Tennis |
| | [phone] |
| Date Prepared: | 01-02-2012 |
| RE: K111588 | |
| Device Trade Name: | Legacy-500 Massage Table |
| Common Name: | Massage Table, IST, Roller Table |
| | 21 CFR 890.5880 |
| Regulatory Class: | Class II |
| Product Code: | JFB |
| Part 890-: | SEC. 890.5880 Multi-Function Physical Therapy Table |
| Substantial Equivalence: | K010252 Magnum, K002390 Quantum 400, K993461 Quest IST |

Device Description: Legacy-500 Massage Table is an electrically powered, motorized, multifunctional physical therapy table. The intended use is to provide muscle relaxation therapy by delivering a soothing massage. It is designed to travel throughout the back area in a smooth transition but can also stop in one specific area. Pressure of the massage can be adjusted from one (łowest setting) to six (highest setting) and is displayed by six lights. Rollers can massage clockwise or counter-clockwise and the indicator displays the position on the back. The timer allows the table to run from one to thirty minutes shutting power off after treatment time and returning the pressure of the rollers to the lowest setting, at any time during treatment the timer can be manually shut off to stop the table by user or patient. The only patient contacting component is the table top that the patient lays on covered in vinyl upholstery.

OCT 26 2012

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Intended Use: Legacy-500 Massage Table is designed to release muscle tension and deliver a soothing massage.

Technological Aspects: A comparison of the device features, intended use and other Information demonstrate that the Legacy-500 Massage Table ls substantially equivalent to the cleared for commercial distribution per K010252, K002390 and K993461.

| Comparison | Legacy-500 | K010252 | K002390 | K993461 |
|-------------------------------------------------------------------------------------------|------------|---------|---------|---------|
| Intended use:<br>Designed to release muscle<br>tension and deliver a soothing<br>massage. | Yes | Yes | Yes | Yes |
| Substantially same size and<br>shape. | Yes | Yes | Yes | Yes |
| Achieve the same physiogical<br>effects | Yes | Yes | Yes | Yes |
| Three six inch diameter<br>massage rollers | Yes | Yes | Yes | Yes |
| Clockwise and counter-<br>clockwise roller rotation | Yes | Yes | Yes | Yes |
| Adjustable roller pressure to<br>place varying degree of<br>pressure on muscles on back | Yes | Yes | Yes | Yes |
| Height of rollers can adjust<br>three inches above baseline<br>table surface | Yes | Yes | Yes | Yes |

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| Comparison | Legacy-500 | K010252 | K002390 | K993461 |
|--------------------------------------------------------------------------------------------------------------------------------------|------------|---------|---------|---------|
| 30 minute timer that shuts<br>power off after cycle time and<br>is also used as the safety shut<br>off | Yes | Yes | Yes | Yes |
| Have the same type of frame<br>construction | Yes | Yes | Yes | Yes |
| Have steel roller carriage | Yes | Yes | Yes | Yes |
| Can massage full back or<br>selectable area | Yes | Yes | Yes | Yes |
| Have lighted height indicator | Yes | Yes | Yes | Yes |
| Have same style electrical<br>components and motors | Yes | Yes | Yes | Yes |
| Ten (10) minute<br>recommended treatment time | Yes | Yes | Yes | Yes |
| Covered in vinyl upholstery | Yes | Yes | Yes | Yes |
| One control / indicator panel<br>at head end of table to<br>prevent patient from kicking<br>controls when getting on or<br>off table | Yes | No | No | No |
| Indicator panel at head end<br>and control panel at foot end<br>of table | No | Yes | Yes | Yes |
| Has optional hand held control<br>and heat option | No | No | Yes | No |

A comparison of the device features, intended use and other information demonstrates that the Legacy-500 is substantially equivalent to the cleared for commercial distribution per K010252, K002390 and K993461.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MT TABLES, LLC % Mr. Milburn Tennis Owner 15 West Mill Street Aurora, Missouri 65605

Re: K111588

Trade/Device Name: Legacy-500 Regulation Number: 21 CFR 890.5880 Regulation Name: Multi-function physical therapy table Regulatory Class: Class II Product Code: JFB Dated: October 09, 2012 Received: October 09, 2012

Dear Mr. Tennis:

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. 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.

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

OCT 26 2012

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Page 2 - Mr. Milburn Tennis

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,
Mark A. Millman

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K111588

Device Name: Legacy-500

Indications For Use: The intended use is to provide muscle relaxation therapy by delivering a soothing massage.

Prescription Use × (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 CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K 111588

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