(279 days)
Not Found
No
The description focuses on mechanical and motorized functions for physical therapy, with no mention of AI or ML terms, data processing, or performance metrics typically associated with AI/ML devices.
Yes
The device description states that the Vibro-Trac™ is a "multi-function physical therapy table intended for medical purposes" and provides "powered distraction and muscle relaxation therapy." These functions clearly indicate its use for therapeutic benefits.
No
The device description and intended use solely describe therapeutic functions (distraction, muscle relaxation, vibration) and do not mention any capabilities for identifying, evaluating, or monitoring a disease or condition.
No
The device description clearly outlines a physical therapy table with motorized components, harnesses, and belts, indicating it is a hardware device with potential software control, not a software-only device.
Based on the provided information, the Vibro-Trac™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's a "multi-function physical therapy table intended for medical purposes that consists of a motorized table which can be equipped to provide patients with powered distraction and muscle relaxation therapy." This describes a physical therapy device used for treatment, not for examining specimens from the human body.
- Device Description: The description details a table with harnesses and belts used to apply spinal muscle relaxation and distraction directly to the patient. This is a physical intervention, not a diagnostic test performed on samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), using reagents, or providing diagnostic information based on laboratory testing of specimens.
IVD devices are used to examine specimens from the human body to provide information for diagnostic, monitoring, or screening purposes. The Vibro-Trac™ is a therapeutic device used for physical treatment.
N/A
Intended Use / Indications for Use
The Vibro-Trac™ is a multi-function physical therapy table intended for medical purposes that consists of a motorized table which can be equipped to provide patients with powered distraction and muscle relaxation therapy.
Product codes (comma separated list FDA assigned to the subject device)
JFB
Device Description
The Pneumex Vibro-Trac™ is a Hi-Lo multifunction distraction/vibration table designed to apply spinal muscle relaxation through vibration.
The patient lies in a supine position on the table with the knees bent and supported at a 90° angle (e.g., supported by an exercise ball). The patient wears an upper body harness, which is attached by shoulder straps and carabineers to the head traction bars at a location to provide greater or less tension, as determined by the medical practitioner. The patient wears a pelvic belt with two tensioning straps, which are attached independently to either side. The pelvic belt allows for anterior, posterior, or inferior traction to provide the required amount of tension, as determined by the medical practitioner.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The Vibro-Trac™ was tested in accordance with the medical electrical equipment requirements defined by:
- IEC 60601-1-2 for electromagnetic compatibility; and
- IEC/UL 60601-1 and CSA C22.2 No. 601.1 for electrical safety.
Finally, laboratory testing was conducted on the Vibro-Trac™ to ensure it would perform optimally during normal use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
1092
510(k) Summary (per 21 CFR 807.92(c))
1. Applicant
Pneumex, Inc 2605 North Boyer Ave. Sandpoint, ID 83864
JUN 1 0 2010
Tonnie Hoisington, Operations Manager Tel: (208) 265-4105 Fax: (208) 265-9651 E-mail: tonnie@pneumex.com
Date Prepared: April 21, 2010
2. Device Name
| Device Name: | Vibro-Trac™ Table |
|---|---|
| Regulation Description: | Multi-Function Physical Therapy Table |
| Regulation Number: | 890.5880 |
| Product Code: | JFB |
| Device Class: | II |
| Review Panel: | Physical Medicine |
3. Predicate Devices
The Vibro-Trac™ Table is substantially equivalent to the following device:
| 510(k)
| Number | Device | Applicant |
|---|---|---|
| K063034 | Air-Flex with Auto Distraction | Hill Laboratories Co. |
4. Indications for Use
The Vibro-Trac™ is a multi-function physical therapy table intended for medical purposes that The Vibro-Trac - 15 a mail: failetion pan be equipped to provide patients with powered distraction and muscle relaxation therapy.
1
5. Description of the Device
The Pneumex Vibro-Trac™ is a Hi-Lo multifunction distraction/vibration table designed to apply The Filednies Vibro Trac - 15 a Free Mard to provide spinal muscle relaxation through vibration.
The patient lies in a supine position on the table with the knees bent and supported at a 90° rne potient hes in a supported by an exercise ball). The patient wears an upper body harness, angle (e.g., Knecs Supported by an exercise and carabineers to the head traction bars at a location to willial is attached by shoulder straps and by the medical practitioner. The patient wears a provide greater of less tension, as actorned to either side. The pelvic belt allows for anterior, pervice belt with two consisting independently. The tensioning straps are mcular, and posterior for or or on provide the required amount of tension, as determined by the medical practitioner.
Summary of the Technical Characteristics 6.
The Vibro-Trac™ was tested in accordance with the medical electrical equipment requirements defined by:
- IEC 60601-1-2 for electromagnetic compatibility; and .
- IEC/UL 60601-1 and CSA C22.2 No. 601.1 for electrical safety. .
Finally, laboratory testing was conducted on the Vibro-Trac™ to ensure it would perform optimally during normal use.
7. Safety and Effectiveness
The Vibro-Trac™ is a safe and effective device and is substantially equivalent to the predicate rife Vibro-Trac - 15 a sate and and encessor, that is, the indications for use for the Vibro-Trac™ device listed in this 520(x) obbition, the subject and predicate devices are similar overlap that of the products any differences in technological characteristics between the Vibro-Trac™ and the predicate device do not raise issues of safety and effectiveness.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circle around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Conmed Corporation % Emergo Group Ms. Jean Asquith Senior Regulatory Affairs Consultant 1705 S. Capital of Texas Highway, Suite 500 Austin, Texas 78746
JUN 1 0 2010
Re: K092731
Trade/Device Name: Vibro-Trac Regulation Number: 21 CFR 890.5880 Regulation Name: Multi-function physical therapy table Regulatory Class: II Product Code: JFB Dated: May 4, 2010 Received: May 4, 2010
Dear Ms. Asquith:
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
3
Page 2 - Ms. Jean Asquith
device-related adverse events) (21 CFR 803); 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.
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 your
Sincerely yours,
Mark N Milkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): _
Device Name: Vibro-Trac
Indications for Use:
The Vibro-Trac™ is a multi-function physical therapy table intended for medical purposes that consists of a motorized table which can be equipped to provide patients with powered distraction and muscle relaxation therapy.
Prescription Use × (Part 21 CFR 801 Subpart D)
Over-The-Counter
(21 CFR 80
Over-The-Counter Use (21 CFR 801 Subpart C)
.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign Off
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092731