(259 days)
Not Found
No
The description details a standard electrical stimulator with adjustable parameters controlled by a clinician and limited user input. There is no mention of AI, ML, or any features that suggest adaptive learning, pattern recognition, or automated decision-making based on data.
Yes
The device is described as a "Stimulator" with several stated "Intended Use / Indications for Use" that clearly aim to treat various medical conditions and symptoms, such as pain relief, muscle relaxation, prevention of atrophy, and increasing range of motion.
No
The provided text describes the device's intended uses for therapeutic purposes like pain relief, muscle stimulation, and increasing circulation, not for diagnosing medical conditions.
No
The device description explicitly states it is a "device which combines the functionality of Interferential (IF), Neuromuscular (NM), High Voltage (HV) and Pulsed Direct Current (PDC) in one device" and "produces a low electrical current that is transmitted via lead wires to electrodes placed on the area predetermined by a clinician." This indicates a physical hardware component that generates and delivers electrical current, not just software.
Based on the provided information, the T.E.A.R. Tech3 IF/Muscle Stimulator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended uses listed are all related to applying electrical stimulation to the body for therapeutic purposes (muscle relaxation, pain relief, circulation, etc.). These are direct treatments applied to the patient's body.
- Device Description: The device description details how it generates and delivers electrical current via electrodes placed on the skin. This is a physical intervention.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVD devices are used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
Therefore, the T.E.A.R. Tech3 IF/Muscle Stimulator is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
IPF, LIH
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 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.
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
Clinician; 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
§ 890.5850 Powered muscle stimulator.
(a)
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.(b)
Classification. Class II (performance standards).
0
510(k) SUMMARY
| 510(k) Owner: | Vision Quest Industries, Inc.
18011 Mitchell South,
Irvine, CA, 92614
Ph. (800) 266-6969
Fax (800) 821-8012 | NOV 13 2009 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact: | Doug Humphrey
Dir. QA and Regulatory Affairs | |
| Date Summary Prepared: | May 22, 2009 | |
| Proprietary Name: | T.E.A.R. Tech 3 | |
| Device Type: | Interferential Stimulator
High Volt Pulsed Current Stimulator
Neuromuscular Electrical Stimulator | |
| Substantial Equivalence: | This device is similar in design, composition
and function to the following devices: | |
| Manufacturer | Product Name | 510(k) Number |
|---|---|---|
| Vision Quest Industries, Inc. | ||
| 18011 Mitchell South | ||
| Irvine, CA 92614 | T.E.A.R. Tech3 | K030507 |
| Staodyn, Inc. | ||
| 1225 Florida Avenue | ||
| P. O. Box 1379 | ||
| Longmont, Colorado 80502-1379 | Tuwave | K921668 |
| Compex Technologies, Inc. | ||
| (formerly Staodyn) | ||
| 1811 Old Highway 8 | ||
| 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
1
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.
2
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
devices that have been reclicate devices mexical devices markets marketstand
devices that have bee devices that have been redastiled in accordine and of the American in interstate
and Cosmetic Act (at in accordance we of the Porculical Derhe Pood, Drug, to
r ou may thet (A and Commit Act (Act (Act the device appre with the provisions of the Federal Food, your and Food, your and Food, your and Food, your and Food, your and your and You may, therefore, make the device, subject to all of a permaker approval approval operiod.
general controls provide approval of a premaket approval of the Act. The a more of the cole, thanks the device, subject to the general controls of the optisation of the optisation of the optisions of the of the of the of the of the of f
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
Plansa has device in the Federal Regulations, Title 21, Parts 800 to 898. In addiser.
Please be advised that FDA is issuance of a substantial equivalence detemination does not mean
that FDA has made a determination that your device complies with over con that Free and FDA s issuance of a substanial equivalence detemination dos not mean
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
Comply with all the Act's requirements, including the more of the Actives (2) CFR Print and the Act Srequirements, including, but not be ited to: registration registration must
device-related adverse events, including, but not be registration of medica device of overse events) (21 CFR 801); medical device reportion and listing (2
device related adverse events) (21 CFR 803); good not meditor regulentes as st സംഭവങ്ങൾ പ്രസ്സ് (21 CFR 803); good manufactupsnag ractive of medical
forth in the quality systems (21 CFR 803); and franceller emergenere electronic the was quality systems (QS) regulation (21 CFR Part 820); and if applicable, the product radiation
product radiation control provisions (Sections 531-542 of the Act); 21 CFR
3
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 (800) 638-2041 or (301) 796-7100 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
4
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