(507 days)
Not Found
No
The description details standard electromechanical functions (motorized movement, pressure adjustment, timer) and does not mention any capabilities that would require AI or ML, such as adaptive massage based on patient input or physiological data, image analysis, or learning from usage patterns.
No
The intended use of the device is for "muscle relaxation therapy by delivering a soothing massage," which typically falls under general wellness or comfort rather than a specific therapeutic medical condition. While it provides a physical effect, it is not presented as treating or diagnosing a disease or condition. The predicate devices listed are also massage tables, reinforcing its wellness rather than therapeutic classification.
No.
The device's explicit intended use is "to provide muscle relaxation therapy by delivering a soothing massage," which is a therapeutic rather than a diagnostic function.
No
The device description clearly describes a physical, electrically powered, motorized massage table with hardware components like rollers, pressure adjustments, and a timer. It is not solely software.
Based on the provided information, the Legacy-500 Massage Table is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to provide muscle relaxation therapy by delivering a soothing massage." This is a therapeutic purpose, not a diagnostic one.
- Device Description: The description details a physical therapy table that provides massage through rollers. It does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information.
- Lack of IVD Indicators: There is no mention of:
- Analyzing biological samples.
- Providing diagnostic results.
- Image processing for diagnostic purposes.
- AI/ML for diagnostic interpretation.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Legacy-500 Massage Table's function is purely therapeutic.
N/A
Intended Use / Indications for Use
The intended use is to provide muscle relaxation therapy by delivering a soothing massage.
Product codes
JFB
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 (lowest 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
back area
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5880 Multi-function physical therapy table.
(a)
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.(b)
Classification. Class II (performance standards).
0
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 |
| (417) 678 2880 | |
| 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
1
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: | ||||
| Designed to release muscle | ||||
| tension and deliver a soothing | ||||
| massage. | Yes | Yes | Yes | Yes |
| Substantially same size and | ||||
| shape. | Yes | Yes | Yes | Yes |
| Achieve the same physiogical | ||||
| effects | Yes | Yes | Yes | Yes |
| Three six inch diameter | ||||
| massage rollers | Yes | Yes | Yes | Yes |
| Clockwise and counter- | ||||
| clockwise roller rotation | Yes | Yes | Yes | Yes |
| Adjustable roller pressure to | ||||
| place varying degree of | ||||
| pressure on muscles on back | Yes | Yes | Yes | Yes |
| Height of rollers can adjust | ||||
| three inches above baseline | ||||
| table surface | Yes | Yes | Yes | Yes |
2
| Comparison | Legacy-500 | K010252 | K002390 | K993461 |
|---|---|---|---|---|
| 30 minute timer that shuts | ||||
| power off after cycle time and | ||||
| is also used as the safety shut | ||||
| off | Yes | Yes | Yes | Yes |
| Have the same type of frame | ||||
| construction | Yes | Yes | Yes | Yes |
| Have steel roller carriage | Yes | Yes | Yes | Yes |
| Can massage full back or | ||||
| selectable area | Yes | Yes | Yes | Yes |
| Have lighted height indicator | Yes | Yes | Yes | Yes |
| Have same style electrical | ||||
| components and motors | Yes | Yes | Yes | Yes |
| Ten (10) minute | ||||
| recommended treatment time | Yes | Yes | Yes | Yes |
| Covered in vinyl upholstery | Yes | Yes | Yes | Yes |
| One control / indicator panel | ||||
| at head end of table to | ||||
| prevent patient from kicking | ||||
| controls when getting on or | ||||
| off table | Yes | No | No | No |
| Indicator panel at head end | ||||
| and control panel at foot end | ||||
| of table | No | Yes | Yes | Yes |
| Has optional hand held control | ||||
| 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.
3
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
4
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 (800) 638-2041 or (301) 796-7100 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
5
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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