(750 days)
Not Found
No
The device description focuses on hardware components and user-controlled settings, with no mention of AI or ML algorithms for data processing, decision-making, or adaptive control.
Yes
The intended use of the device is for muscle relaxation and increased local blood circulation, and the device description explains that it is used to decrease the tension of muscle fibers and leads to greater blood flow, all of which are therapeutic purposes. Additionally, the performance studies indicate its function as a powered muscle stimulator for temporary relief of muscle spasms, which is a therapeutic outcome.
No
The device description states its purpose is for "muscle relaxation and increased local blood circulation" and "to decrease the tension of the muscle fibers and leads to greater blood flow", and the performance studies indicate its function as a "powered muscle stimulator for temporary relief of muscle spasms." None of these functions involve diagnosis.
No
The device description explicitly lists multiple hardware components including a user interface overlay, external power supply, main board, output channels, stimulation circuits, cables, and a metal enclosure. This indicates it is a physical device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is "Muscle relaxation and increased local blood circulation." This is a therapeutic application, not a diagnostic one.
- Device Description: The device is described as a "powered muscle stimulator" that sends electrical pulses to muscles. This is consistent with a physical therapy or pain management device, not a device used to test samples from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. This device's function is to directly interact with the body for therapeutic purposes.
N/A
Intended Use / Indications for Use
Muscle relaxation and increased local blood circulation.
Product codes (comma separated list FDA assigned to the subject device)
IPF
Device Description
The TM20 is a device used for muscle relaxation. It sends biphasic pulses to targeted distressed muscles, and by delivering a specified sequence of timed and abrupt electrical frequency pulses, the device can be used to decrease the tension of the muscle fibers and leads to greater blood flow.
The user operates the device by means of a keypad overlay. The overlay allows for the user to adjust the treatment length, adjust intensity of each stimulation output, adjust maximum power of stimulation, and start, pause, and stop treatment. The values being set and current stage of treatment is displayed to the user by means of an LCD display, alpha numeric displays, and LEDs.
Future revisions of the product are intended to be controlled by means of a Laptop or Tablet which will rest on the surface of the enclosure and connect to the device by means of a Slave USB cable. This capability will be implemented in hardware but not firmware.
The TM20 device consists of the following:
-
- User Interface Overlay
-
- External Power Supply for TM20
-
- A main board for controlling and monitoring the generated output
-
- 10 Individual output channels, and a stimulation circuit for each channel
-
- Communication and stimulation cables
-
- A custom bent metal enclosure
The TM20 device is designed, assembled, and tested to medical device standards of a Class 2 device which meets all safety and regulatory requirements for Health Canada and the FDA. The device is designed to operate from 10-35 degrees Celsius.
- A custom bent metal enclosure
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)
After performing non-clinical performance studies, the data shows that the MyoWorx TM20 is substantially equivalent to the predicate in its sole function as a powered muscle stimulator for temporary relief of muscle spasms. The subject device has fewer functions than the predicate and the differences between it and the predicate device do not raise new issues of safety or effectiveness.
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
§ 890.5850 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
October 19, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
MyoWorx Inc. % Darren Reeves President DP Distribution & Consulting, LLC. 12240 Hunting Horn Lane Rockville, Virginia 23146
Re: K192746
Trade/Device Name: MyoWorx TM20 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF Dated: July 15, 2021 Received: July 15, 2021
Dear Darren Reeves:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for CDR Jitendra Virani, MS Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K192746
Device Name MyoWorx TM20
Indications for Use (Describe) Muscle relaxation and increased local blood circulation.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
In accordance with 210 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the MyoWorx TM20 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.
| Sponsor: | MyoWorx Inc.
77 Westmount Road Suite 201
Guelph, Ontario, N1H5J1 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person/Prepared by: | Darren Reeves
President
DP Distribution & Consulting, LLC
(804) 307-7706
dreeves@dpdconline.com
7305 Hancock Village Drive
Suite 109
Chesterfield, Virginia 23832 |
| Date: | 10/13/2021 |
| Subject Device: | Trade Name: MyoWorx TM20
Common Name: Powered Muscle
Stimulator
Classification Name: Powered Muscle
Stimulator (21 CFR 878.5850, Product Code
IPF) |
| Predicate Device: | Mettler Electronics Corp., Sys*Stim® 294
(ME294) (K984114) |
Purpose and Device Description:
The TM20 is a device used for muscle relaxation. It sends biphasic pulses to targeted distressed muscles, and by delivering a specified sequence of timed and abrupt electrical frequency pulses, the device can be used to decrease the tension of the muscle fibers and leads to greater blood flow.
The user operates the device by means of a keypad overlay. The overlay allows for the user to adjust the treatment length, adjust intensity of each stimulation output, adjust maximum power of stimulation, and start, pause, and stop
4
treatment. The values being set and current stage of treatment is displayed to the user by means of an LCD display, alpha numeric displays, and LEDs.
Future revisions of the product are intended to be controlled by means of a Laptop or Tablet which will rest on the surface of the enclosure and connect to the device by means of a Slave USB cable. This capability will be implemented in hardware but not firmware.
The TM20 device consists of the following:
-
- User Interface Overlay
-
- External Power Supply for TM20
-
- A main board for controlling and monitoring the generated output
-
- 10 Individual output channels, and a stimulation circuit for each channel
-
- Communication and stimulation cables
-
- A custom bent metal enclosure
The TM20 device is designed, assembled, and tested to medical device standards of a Class 2 device which meets all safety and regulatory requirements for Health Canada and the FDA. The device is designed to operate from 10-35 degrees Celsius.
Intended Use and Indication for Use:
Muscle relaxation and increased local blood circulation.
Comparison of Predicate Device:
The MyoWorx TM20 is substantially equivalent in intended use, design, technology/principles of operation, materials, and performance to the Sys*Stem ® 294 (ME294) (K984114). Differences between the devices cited in this section do not raise any new issue of substantial equivalence.
Side by Side Device Comparison Table:
Predicate Device, Sys*Stim® 294 (ME294) and Proposed Device, MyoWorx TM20
| Elements of
Comparison | Subject Device | Predicate Device
(K984114) | Similarity |
|---------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Device Name | MyoWorx TM20 | Sys*Stim® 294
(ME294) | N/A |
| 510 (k) Number | Applying | K984114 | N/A |
| Product Code | IPF | IPF, LIH and GZJ | Substantially
equivalent |
| Regulation Number | 882.5890 | 882.5890 | Same |
| Intended Use | | | |
| Intended Use | Muscle relaxation
and increased local
blood circulation. | 1. Symptomatic relief
of chronic pain,
acute post traumatic
pain or acute post-
surgical pain
(interferential,
Premodulated and
Microcurrent
waveforms). | Substantially
equivalent |
| | | 2. Temporary
relaxation of muscle
spasm, (all
waveforms except
Microcurrent). | |
| | | 3. Prevention of
post-surgical phlebo-
thrombosis through
immediate
stimulation of calf
muscles, (all
waveforms except
Microcurrent). | |
| | | 4. Increase of blood
flow in the treatment
area (all waveforms
except
Microcurrent). | |
| | | 5. Prevention or
retardation of disuse
atrophy in post-
injury type
conditions, (all
waveforms except
Microcurrent). | |
| | | 6. Muscle re-
education, (all
waveforms except
Microcurrent). | |
| | | 7. Maintaining or
increasing range of
motion, (all
waveforms except
Microcurrent). | |
| Power Source | UL Listed Medical
Grade Power supply
cable between 100-
240VAC, 50/60Hz | Detachable U.L.
Listed, hospital-
grade line cord (ME
7293) between 90-
240 VAC, 50-60Hz | Substantially
equivalent |
| Method of Line
Current Isolation | External 60601 power
supply plus output
transformers rated at
4,000VAC | Yes | Same |
| Patient Leakage
current
-Normal condition | 95% dip in UT) for 0.5 cycle
40% UT
(60% dip in UT) for 5 cycles
70% UT
(30% dip in UT) for 25 cycles
95% dip in UT) for 5 seconds | Substantially equivalent |
| Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8 | 30 A/m | 3 A/m | Substantially equivalent |
| Conducted RF
IEC 61000-4-6 | 3 Vrms, 150 kHz-80 MHz
6 Vrms ISM/Amateur radio bands inside 150 kHz-80MHz | 3 Vrms | Substantially equivalent |
| Radiated RF
IEC 61000-4-3 | 3 V/m, 80 MHz-2.7GHz
RF communication equipment inside 80 MHz-6GHz | 3 V/m | Substantially equivalent |
| Input | 100-240V 1.4A, 50/60Hz | 90-240VAC, 50-60Hz, 2.3 Amp Nom. | Substantially equivalent |
| Operating
Temperature | 10 ℃ to 35℃ | +50℉ to +104℉ | Substantially equivalent |
| Humidity | Operating, Relative | Operating, 30% to | Substantially |
| | Humidity 30% to 75%
Non-Condensing | 75% Relative
Humidity at 104F | equivalent |
| | Storage, Relative
Humidity 10% to 90%
Non-Condensing | Nonoperating, 5 to
95% Relative
Humidity, non-
condensing | |
| Storage
Temperature | -10 °C to 60°C | -40°F to 167°F | Substantially
equivalent |
| Timer Accuracy | ±25 parts per million
(ppm) | ±30 seconds | Different |
| Timer Range | 30, 45, 60 and 90
minutes | Maximum Time 60
minutes | Different |
| Console Weight | 5.2 pounds (without
accessories) | 9.4 pounds | Substantially
equivalent |
| Dimensions | 3.45" (thickest point)
and 1.26" (thinnest
point) x
14.000"x8.690"
(HxWxD)-excluding
feet | 5" (H) x 14.5" (W) x
10" (D) | Substantially
equivalent |
| Waveform | Biphasic or
Monophasic,
Rectangle | Interferential,
Premodulated,
Medium Frequency,
Symmetrical
Biphasic, High Volt,
and Microcurrent,
Square | Substantially
equivalent |
| Maximum Output
Voltage (+/- 10%) | 0V-75V +/-5% (peak),
with 1kOhm loads | 99 volts peak, 1Kohm
load (Symmetrical
Biphasic) | Different |
| Maximum Output
Current | 0.120A, with 500Ohm
load | 7.2 mA | Different |
| Frequency Range | 1-120Hz | 1-120Hz | Same |
| Pulse Width Range | 200µs | 50-300µs | Substantially
equivalent |
| Method of Line
Current Isolation | External 60601 power
supply plus output
transformers rated at
4,000VAC | Yes | Substantially
equivalent |
| Synchronous or
Alternating | Synchronous | Unknown | Unknown |
| or Regulated
Voltage | | | |
| Software/Firmware
Microprocessor
control | Firmware
microprocessor
control | Microprocessor
control | Same |
| Indicator Display
On/Off Status | Yes | Yes | Same |
| Indicator Display
Low Battery | N/A | N/A | Same |
| Indicator Display
Voltage/Current
Level | Yes | Yes | Same |
| Net Charge | 24ucoulombs per
pulse | Unknown | Probably
equivalent |
| Maximum Current
Density | 0.0032A/sqcm | 0.0036A/sqcm | Substantially
equivalent |
| Maximum Power
Density | 0.09W/sqcm | Unknown | Probably
equivalent |
| On Time | 19.5 seconds | 1-240 seconds | Different |
| Off Time | 0.5 seconds | 1-240 seconds | Different |
5
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Substantial Equivalence Conclusion:
After performing non-clinical performance studies, the data shows that the MyoWorx TM20 is substantially equivalent to the predicate in its sole function as a powered muscle stimulator for temporary relief of muscle spasms. The subject device has fewer functions than the predicate and the differences between it and the predicate device do not raise new issues of safety or effectiveness. Regarding any differences, the following paragraphs provide additional explanations:
Number of output modes: The predicate device has six different output modes versus one output mode in the MyoWorx TM20. The single output mode in the subject device is the same as the "Biphasic" output mode in the predicate device. Not having the same number of output modes as the predicate does not raise new issues of safety or effectiveness and simplifies the function and operation of the subject device.
Number of output channels: The predicate device has four channels and the MyoWorx TM20 device has 10 channels. This difference allows the TM20 device to apply the intended effect to more muscles at one time as compared with
10
predicate device. As demonstrated through clinical validation, this difference does not impact upon safety or effectiveness.
Automatic shut-off: The MyoWorx TM20 does not automatically shut-off but rather goes into a sleep mode with all outputs turned off other than an indicator LED light.
Timer Accuracy: The timer in the MyoWorx TM20 has greater accuracy than the predicate.
Timer Range: The minimum time of 30 minutes and maximum time of 90 minutes for the TM20 versus a selectable range of up to 60 minutes for the predicate device does not affect safety or effectiveness as current delivery in the MyoWorx TM20 is applied for a maximal allowable duration, which is greater than 10 times less the allowable duration of the predicate.
Maximum Output Voltage: The predicate device has a maximum output voltage of 99 volts (output mode same as subject device) and the MyoWorx TM20 has a maximum voltage of 75 volts. The TM20 device is substantially as safe as the predicate due to the lesser maximum voltage output and substantially as effective as the voltage level is well within the physiological range to produce the intended effect of muscle relaxation and increased local blood circulation.
Maximum Output Current: The predicate device has a lower maximum output current than the subject device, however safety or effectiveness is not affected as current delivery in the MyoWorx TM20 is applied for a maximal allowable duration, which is greater than 10 times less the allowable duration of the predicate.
On-Time: Selectable for the predicate and preset for the subject device, controlling safe delivery of the stimulus.
Off-Time: Selectable for the predicate and preset for the subject device.
None of the above-identified differences have any adverse effect on the safety or effectiveness of the subject device when compared with the predicate.