VIBRO-TRAC

K092731 · Pneumex, Inc. · JFB · Jun 10, 2010 · Physical Medicine

Device Facts

• Record ID: K092731
• Device Name: VIBRO-TRAC
• Applicant: Pneumex, Inc.
• Product Code: JFB · Physical Medicine
• Decision Date: Jun 10, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5880
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Vibro-Trac is a Hi-Lo multifunction distraction/vibration table; provides spinal muscle relaxation via vibration. Patient lies supine with knees supported (e.g., exercise ball); wears upper body harness attached to head traction bars; wears pelvic belt with tensioning straps. Medical practitioner determines tension levels and harness/belt positioning. Used in clinical physical therapy settings. Device applies mechanical distraction and vibration to facilitate muscle relaxation. Benefits include targeted spinal tension management and therapeutic muscle relaxation.

Clinical Evidence

Bench testing only. Testing performed per IEC 60601-1-2 (EMC) and IEC/UL 60601-1/CSA C22.2 No. 601.1 (electrical safety). Laboratory testing conducted to ensure optimal performance during normal use.

Technological Characteristics

Hi-Lo motorized physical therapy table. Features head traction bars and pelvic belt system for tensioning. Electrical safety per IEC/UL 60601-1 and CSA C22.2 No. 601.1. EMC per IEC 60601-1-2. No software or algorithmic components described.

Indications for Use

Indicated for patients requiring powered distraction and muscle relaxation therapy in a physical therapy setting.

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

• Air-Flex with Auto Distraction (K063034)

Submission Summary (Full Text)

{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: [phone] Fax: [phone] E-mail: [e-mail]

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)<br>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 [phone] or [phone] 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