(232 days)
No
The device description and intended use are typical for a standard NMES device and do not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is indicated for conditions such as relaxation of muscle spasms, prevention or retardation of disuse atrophy, and increasing local blood circulation, which are therapeutic applications.
No
The device is a Neuromuscular Electrical Stimulator (NMES) used for therapeutic purposes like muscle relaxation, re-education, and circulation, not for diagnosing conditions.
No
The device description explicitly states that the Ttech NMES system includes hardware components such as electrodes with lead wires, a battery, and a carrying case, in addition to the device itself which produces the electrical current. This indicates it is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body ("in vitro").
- Ttech NMES Function: The Ttech NMES is a Neuromuscular Electrical Stimulator (NMES). It applies electrical current to the body through electrodes placed on the skin. This is an in vivo (within the living body) application, not an in vitro test.
- Intended Use: The listed intended uses are all related to directly stimulating muscles and affecting physiological responses within the body. None involve analyzing biological specimens.
- Device Description: The description details a device that delivers electrical current via leads and electrodes, not a device that processes or analyzes biological samples.
Therefore, based on the provided information, the Ttech NMES is a therapeutic medical device used for direct electrical stimulation of muscles, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
As an NMES device, the Ttech NMES is indicated for the following conditions:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and
- Maintaining or increasing range of motion
Product codes
IPF
Device Description
The Ttech NMES is a dual channel NMES device that produces a mild electrical current that is transmitted via leads to electrodes placed on the skin in areas predetermined by the clinician. The device, a set of electrodes with their lead wires, a battery (9 volt), carrying case, and instructions for use make up the Ttech NMES system.
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
Bench testing raised no additional patient safety or performance issues so clinical testing was not indicated
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
Exhibit #1
Page 1 of 4
510(K) SUMMARY
This summary of 5l0(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
2013768 The assigned 5l0(k) number is:_
Submitter's Identification:
Theratech, Inc. 1109 Myatt Blvd. Madison, TN 37115 FDA Registration: To be applied for Phone: 615-865-4000 Fax: 800-485-2626
Date Summary Prepared:
November 6, 2001
Name of the Device:
- Trade Name: Ttech NMES a.
- b. Common Name or Classification Name of Device: Powered Muscle Stimulator/Neuromuscular Stimulation (NMES) System
The Physical Medicine Device Panel (DGRD) has classified this device as Class II. 21 CFR Part 890.5850, Product Code 89 IPF.
Predicate Device Information:
NMES:
K951951, EMPI Focus Powered Muscle Stimulator (NMES), EMPI, Inc., 5255 East River Road, Fridley, MN 55421; K003596, RESTIM, Smith and Nephew, Inc. N104 W13400 Donges Bay Rd., Germantown, WI 53022.
Electrode Leads:
K002874. Well-TENS (various model of TENS). Well-Life Healthcare, Inc., Ltd., Taichaung, Taiwan. (the leads are the same for the NMES as for the TENS)
1
Electrodes:
Wandy Rubber Industrial Co., Ltd. Self-Adhesive Neurostimulation Electrodes, K002219
Device Description: The Ttech NMES is a dual channel NMES device that produces a mild electrical current that is transmitted via leads to electrodes placed on the skin in areas predetermined by the clinician. The device, a set of electrodes with their lead wires, a battery (9 volt), carrying case, and instructions for use make up the Ttech NMES system.
Intended Use:
As an NMES device, the Ttech NMES is indicated for the following conditions:
- Relaxation of muscle spasms .
- . Prevention or retardation of disuse atrophy
- Increasing local blood circulation .
- . Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent . venous thrombosis; and
- t Maintaining or increasing range of motion
Comparison to Predicate Devices:
See attached comparison chart
Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence:
In addition to performance testing for comparison purposes, the following testing was also completed:
2
Page 3 of 4
Patient Lead Safety Testing (21 CFR 898) Test for open /short circuit performance Temperature endurance test Incorrect battery installation test Vibration Test Mechanical Shock Test Humidity endurance test Water immersion endurance test
Discussion of Clinical Tests Performed:
Bench testing raised no additional patient safety or performance issues so clinical testing was not indicated
Conclusions:
The Ttech NMES has the same intended use and technological characteristics as the predicates. No new questions of safety or effectivness have been raised, therefore the Ttech NMES is substantially equivilent to the predicates.
3
| Manufactures | Empi | Smith & Nephew | Theratech |
|---|---|---|---|
| Model Number | Empi FOCUS | RESTIM | Ttech NMES |
| 510(k) Number | K951951 | K003596 | To be assigned |
| Equipment Classification | Hand held. Internally | ||
| Powered | Hand held. Internally | ||
| powered | Hand held. Internally | ||
| powered | |||
| Output Modality | programmable pulse on/off | ||
| times and biphasic. | Fixed, Single. | ||
| rechargeable NiMN 8.4V | Fixed. Single | ||
| Power source | Primary cell, 9V PP3 battery | PP3 battery | 9 Volt Battery |
| Recharge Regime | Replace battery. | In situ. | Replace battery |
| Patient connection | Type BF. Isolated. | Type BF. Isolated. No | |
| patient connection is | |||
| possible during recharge. | Type BF. Isolated | ||
| Current pulse regulation | Good. | Good | Good |
| Maximum output current | 60mA | 90mA | 93mA |
| Load range | 8ohm to 10Kohm | 8ohm to open circuit | 8ohm to open circuit |
| Maximum ouput voltage | +120V | +55V | +100V |
| Maximum phase charge | 3.12 uC. | 2.73 uC. | 21uC |
| Peak current density* | 7.92mA/cm2 | 12.45 mA/cm² | 0.125MAKm² |
| Maximum Power Density** | 4.09X10-5W/cm2 | 4.29X10-6W/cm2 | .0058W/cm² |
| Pulse shape | Symmetric or asymmetric | ||
| biphasic. | Asymmetric Biphasic | Asymmetrical Biphasic | |
| Pulse pattern | Simple. Programmable | ||
| repetition rate. | Complex. One second | ||
| repetition rate | Complex | ||
| User set-up method | Multiple rotary dials. | Two switches for intensity | |
| increase/decrease | Multiple Rotary Dials | ||
| User display | None. | 2 digit LCD plus LED | none |
| Low battery detect | Partial | Yes | Partial |
| Connection error indication | None. | Yes (open cct) | None |
| Treatement time | Selectable between 15 mins | ||
| or continuous. | 1 hour fixed | 15min - 30min or | |
| Continuous | |||
| Pulse width | Nominal 260 usec. User | ||
| adjustable | Nominal 250usec. Can be | ||
| set between 50 and | |||
| 350usec by the user. | 250usec (fixed) |
ﺮ ﺍ
,
4
Image /page/4/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an emblem featuring a stylized depiction of an eagle with three human profiles incorporated into its body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 2002 JUL
Theratech, Inc. C/o Ms. Susan Goldstein-Falk MDI Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, New York 11021
Re: K013768
Trade/Device Name: Ttech NMES Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: IPF Dated: April 5, 2002 Received: April 9, 2002
Dear Ms. Goldstein-Falk:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k)
5
Page 2 - Ms. Goldstein-Falk
premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Styp Rhodes
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Exhibit B
Page 1 of of 1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Theratech, Inc. Ttech NMES
Indications For Use:
As an NMES device, the Ttech NMES is indicated for the following conditions:
- Relaxation of muscle spasms 1.
-
- Prevention or retardation of disuse atrophy
-
- Increasing local blood circulation
- Muscle re-education 4.
-
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and
-
- Maintaining or increasing range of motion
(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 of General, Restorative and Neurological Devices
| 510(k) Number | K013768 |
|---|---|
| --------------- | --------- |
510(k) Number_________________________________________________________________________________________________________________________________________________________________
Prescription Use × (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)