T.E.A.R. TECH3

K090532 · Vision Quest Industries, Inc. · IPF · Nov 13, 2009 · Physical Medicine

Device Facts

• Record ID: K090532
• Device Name: T.E.A.R. TECH3
• Applicant: Vision Quest Industries, Inc.
• Product Code: IPF · Physical Medicine
• Decision Date: Nov 13, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The T.E.A.R. Tech3 IF/Muscle Stimulator is intended for the following applications: The High Volt Pulsed Current Stimulation and Neuromuscular Electrical Stimulation can be used in the following applications: - Relaxation of muscle spasms - . Prevention or retardation of disuse atrophy - . Increases local blood circulation - . Muscle re-education - . Maintaining or increasing range of motion - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Interferential Stimulation can be used in the following applications: - Symptomatic relief of post traumatic acute pain - Symptomatic relief of chronic pain intractable pain - . Relaxation of muscle spasms - Maintaining or increasing range of motion - Increases local blood circulation Pulsed Direct Current stimulation can be used in the following applications: - Reduction of edema (under negative electrode) - . Relaxation of muscle spasm - Increasing local blood circulation - Retardation or prevention of disuse atrophy - Muscle re-education - Maintaining or increasing of range of motion

Device Story

T.E.A.R. Tech 3 is a multi-modal electrical stimulator combining Interferential (IF), Neuromuscular (NM), High Voltage (HV), and Pulsed Direct Current (PDC) stimulation. Device delivers low electrical current via lead wires to electrodes placed on patient skin by a clinician. System features LCD display and keypad for user interface. Clinicians adjust operating parameters; end-users limited to protocol selection and amplitude. Used in clinical settings to manage pain, improve circulation, and support muscle rehabilitation. Output affects clinical decision-making by providing therapeutic electrical stimulation to target tissues, potentially benefiting patients through pain relief, edema reduction, and muscle function maintenance.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use comparisons to predicate devices.

Technological Characteristics

Multi-modal electrical stimulator (IF, NM, HV, PDC). Features LCD display and keypad interface. Delivers electrical current via lead wires and electrodes. Powered muscle stimulator (21 CFR 890.5850).

Indications for Use

Indicated for patients with chronic or acute pain syndromes and/or recovery from orthopedic surgery. Used for muscle spasm relaxation, disuse atrophy prevention, local blood circulation increase, muscle re-education, range of motion maintenance, post-surgical calf stimulation to prevent venous thrombosis, and edema reduction.

Regulatory Classification

Identification

A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.

Predicate Devices

• T.E.A.R. Tech3 (K030507)
• Tuwave (K921668)
• IF3 Wave (K050046)

Submission Summary (Full Text)

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K090532

## 510(k) SUMMARY

| 510(k) Owner: | Vision Quest Industries, Inc.<br>18011 Mitchell South,<br>Irvine, CA, 92614<br>Ph. [phone]<br>Fax [phone] | NOV 13 2009 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact: | Doug Humphrey<br>Dir. QA and Regulatory Affairs | |
| Date Summary Prepared: | May 22, 2009 | |
| Proprietary Name: | T.E.A.R. Tech 3 | |
| Device Type: | Interferential Stimulator<br>High Volt Pulsed Current Stimulator<br>Neuromuscular Electrical Stimulator | |
| Substantial Equivalence: | This device is similar in design, composition<br>and function to the following devices: | |

| Manufacturer | Product Name | 510(k) Number |
|-------------------------------------------------------------------------------------------------|----------------|---------------|
| Vision Quest Industries, Inc.<br>18011 Mitchell South<br>Irvine, CA 92614 | T.E.A.R. Tech3 | K030507 |
| Staodyn, Inc.<br>1225 Florida Avenue<br>P. O. Box 1379<br>Longmont, Colorado 80502-1379 | Tuwave | K921668 |
| Compex Technologies, Inc.<br>(formerly Staodyn)<br>1811 Old Highway 8<br>New Brighton, MN 55112 | IF3 Wave | K050046 |

Device Description:

The T.E.A.R. Tech 3 IF/Muscle Stimulator is a device which combines the functionality of Interferential (IF), Neuromuscular (NM), High Voltage (HV) and Pulsed Direct Current (PDC) in one device. The device produces a low electrical current that is

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transmitted via lead wires to electrodes placed on the area predetermined by a clinician. Operating parameters can be adjusted throughout their range by a trained clinician but the end-user is limited to protocol selection and amplitude. The user interface consists of an LCD display and keypad.

Indications for Use:

The T.E.A.R. Tech3 IF/Muscle Stimulator is intended for the following applications:

The High Volt Pulsed Current Stimulation and Neuromuscular Electrical Stimulation can be used in the following applications:

- Relaxation of muscle spasms
- . Prevention or retardation of disuse atrophy
- . Increases local blood circulation
- . Muscle re-education
- . Maintaining or increasing range of motion
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis

Interferential Stimulation can be used in the following applications:

- Symptomatic relief of post traumatic acute pain
- Symptomatic relief of chronic pain intractable pain
- Relaxation of muscle spasms
- Maintaining or increasing range of motion
- Increases local blood circulation

Pulsed Direct Current stimulation can be used in the following applications:

- Reduction of edema (under negative electrode)
- . Relaxation of muscle spasm
- Increasing local blood circulation
- Retardation or prevention of disuse atrophy
- Muscle re-education
- Maintaining or increasing of range of motion

The target population for this device is patients with chronic, acute pain syndrome, and/or recovering from orthopedic related surgery.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name arranged in a circular pattern around the perimeter. In the center of the seal is a stylized graphic of an eagle, which is a common symbol of the United States.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609
Silver Spring MD 20000 Silver Spring MD 20000 Silver Spring, Control Room W-C
Silver Spring, MD 20993-00022

Vision Quest Industries, Inc. % Mr. Wallace Fischer 18011 Mitchell South Irvine, California 92614

Re: K090532

NOV 1:3 2009

Trade/Device Name: T.E.A.R. Tech3 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator
Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF, LIH Dated: October 13, 2009 Received: October 16, 2009

Dear Mr. Fischer:

We have reviewed your Section 510(k) premar

We have reviewed your Section 510(k) premarket notification of intent to market the device i
referenced above and have determined the device is substantially accuracy of the referenced your Section 5 IQ(x) premarket notification of intent to market the device
for use stated in the enclosure is substantially equivalent (for the indications for use as associated in the device is substantial of market the device the device on the world in the chooder to legally marked produced double smarketings
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edulterat the Actuations provisions of the Act include requirements for annual registration, little Artistian
devices, good manufacturing practice, labeling, and prohibitions against m

If your device is classified (see above)

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 a ing and of too is eassified isee above) into either class II (Special Controls) or class III (PMA),
it may be subject o additional controls. Existing major regulations affe and in the Code of Federal Regulations, Title 21, 2014 of the Solars (11 (PM) 2017) of class III (PM)
found in the Code of Federal Regulations, Title 21, Dr. addition, FDA ma publish further announcements concerning your device in the Reduble Sept. In additions
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Please be advised that FDA is issuance of a substantial equivalence detemination does not mean
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or arrean statues and regulation that your device complies with other requirements of the A on any Federal station that your device completed with are regulters and regulters not one notener more nonement met nom more nomen more monement met monther more . You must on the real outlines and reguliements, including the Federal agences. You more
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Page 2 - Mr. Wallace Fischer

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

[signature]

EDK 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

K090532 510(k) Number (if known):

Device Name: T.E.A.R. Tech3

Indications For Use:

The T.E.A.R. Tech3 IF/Muscle Stimulator is intended for the following applications:

The High Volt Pulsed Current Stimulation and Neuromuscular Electrical Stimulation can be used in the following applications:

- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy .
- Increases local blood circulation .
- Muscle re-education •
- Maintaining or increasing range of motion
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis

Interferential Stimulation can be used in the following applications:

- Symptomatic relief of post traumatic acute pain
- . Symptomatic relief of chronic pain intractable pain
- . Relaxation of muscle spasms
- Maintaining or increasing range of motion
- Increases local blood circulation

Pulsed Direct Current stimulation can be used in the following applications:

- Reduction of edema (under negative electrode)
- Relaxation of muscle spasm
- . Increasing local blood circulation
- Retardation or prevention of disuse atrophy
- Muscle re-education
- Maintaining or increasing of range of motion

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 CDRH, Office of Device Evaluation (C

FOR M.NELSON

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

Page 1 of 1

510(k) Number

Number K090532