(224 days)
The SLENDERTONE® CoreFit Abs 8, Type 734 is indicated for the improvement of abdominal muscle tone, for strengthening of abdominal muscles, and for the development of a firmer abdomen.
The SLENDERTONE® CoreFit Abs 8, Type 734 is a portable neuromuscular electrical stimulator intended to deliver electrical stimulation to the abdominal muscles. The device includes a control unit, abdominal garment, 3 adhesive gel pads (electrodes), USB cable and instructions for use. It contains ten pre-installed programs. The control unit is connected to the abdominal belt garment via three magnetic connectors. The control unit contains the primary controls for operation of the device and push buttons are available for switching the unit on off and to increase or decrease the stimulation intensity. The SLENDERTONE® CoreFit Abs 8. Type 734 contains an Organic Light-Emitting Diode (OLED) display which indicates status relating to battery charge and stimulation. Power is derived from a 3.7V Li-Po rechargeable battery pack and the unit can be recharged by using the supplied USB cable.
This document is a 510(k) premarket notification for a medical device called SLENDERTONE CoreFit Abs 8, Type 734. It's a review by the FDA to determine if the device is "substantially equivalent" to a legally marketed predicate device. This type of submission relies on comparisons to existing devices rather than extensive clinical studies to prove effectiveness.
Therefore, the provided document does not contain the kind of detailed information about acceptance criteria, efficacy studies, expert adjudication, or MRMC studies that you requested for an AI/ML-based medical device.
The study described here is primarily safety and performance testing against electrical and electromagnetic compatibility standards, and biocompatibility testing of materials. It does not involve a "study that proves the device meets the acceptance criteria" in the sense of demonstrating improvement in muscle tone or strength through a clinical trial with human subjects and outcome metrics.
Here's an explanation based on the provided document, addressing your points where possible, and highlighting what is not present:
Key Takeaway from the Document:
The SLENDERTONE CoreFit Abs 8, Type 734 is an electrical muscle stimulator. Its clearance is based on substantial equivalence to a predicate device (Slendertone System Ultra, Type 390, Model E70/X70), meaning its technological characteristics and intended use are similar enough not to raise new questions of safety or effectiveness. This is not a new technology being proven effective through a clinical trial, but rather a demonstration that a new product design is as safe and performs similarly to an already approved one.
Here's a breakdown of the requested information, with answers based on the document and explanations for what is not applicable or present:
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A table of acceptance criteria and the reported device performance
The document does not provide acceptance criteria and reported device performance in terms of clinical efficacy (e.g., specific metrics for "improvement of abdominal muscle tone" or "strengthening of abdominal muscles" that would be measured in human subjects).
Instead, it discusses biocompatibility testing results and compliance with international safety and performance standards for electrical medical devices.
Table for Biocompatibility Testing:
Test Result Toxicological Conclusion Cytotoxicity Test: MTT Method MEM with 10% FBS Extract Potential toxicity at extract concentration >=75% No toxicological risk to users. Cytotoxicity Test: MTT Method MEM Extract No potential cytotoxic potential No toxicological risk to users. Skin sensitization: Buehler test in guinea pigs Dermal scoring using the Magnusson and Kligman scoring system was graded as 0 (no visible change) No toxicological risk to users. Skin irritation Test: Direct contact No abnormal signs were observed during the study. The response of skin on test side did not exceed that on the control side. No toxicological risk to users. Performance Testing (Compliance with Standards):
The document states: "Performance testing was conducted in accordance with the following international standards for safety:" followed by a list of IEC 60601 series standards (e.g., IEC 60601-1, IEC 60601-1-6, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11) and IEC 62133 for battery testing.
The "acceptance criterion" here is compliance with these standards, which implies the device demonstrated it met the requirements (e.g., limits for leakage current, electromagnetic compatibility, usability, etc.). The specific numerical results of these tests (e.g., exact leakage current measurements) are not detailed in this summary. -
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document refers to engineering and biocompatibility testing, not human clinical trials or AI model validation data.
- Biocompatibility: The tests used guinea pigs for skin sensitization and likely in-vitro cell cultures for cytotoxicity. The sample sizes for these biological tests are not specified in this summary.
- Electrical Performance: These involve testing the device hardware against electrical and EMC standards. The "sample size" would typically be a few devices subjected to a series of tests in a lab.
- Data Provenance: Not applicable in the context of clinical data. The tests were conducted to international standards, presumably in a controlled lab environment.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable. The "ground truth" for this device's clearance is its compliance with recognized safety and performance standards and its technological similarity to a legally marketed predicate device. There is no "test set" in the context of clinical images or patient data that would require expert annotation to establish ground truth for an AI algorithm.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no human reading or interpretation task that requires adjudication for this type of device clearance.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. This device is an electrical muscle stimulator, not an AI diagnostic tool that assists human readers. Therefore, an MRMC study is not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm. Its performance is inherent to its electrical stimulation characteristics and physical design, not software-based interpretation of data.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this 510(k) clearance is:
- Compliance with established electrical safety and performance standards (IEC 60601 series).
- Acceptable biocompatibility test results.
- Demonstrated equivalence of technological characteristics and indications for use to a legally marketed predicate device.
- Failure of a device to meet specific criteria outlined in these standards (e.g., excessive leakage current, failure of an electrical test) would constitute a "non-compliance" or "failure" against this ground truth.
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The sample size for the training set
Not applicable. This device does not use an AI/ML algorithm that requires a training set.
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How the ground truth for the training set was established
Not applicable. There is no training set for an AI/ML algorithm.
In summary, the provided document describes a 510(k) substantial equivalence submission for a powered muscle stimulator. This process focuses on demonstrating safety and performance equivalence to an existing device through engineering tests and biocompatibility analysis, rather than proving clinical efficacy of a novel technology or validating an AI algorithm with clinical data. Therefore, most of your specific questions related to AI/ML device validation are not applicable to this document.
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October 25, 2018
Bio-Medical Research Ltd Eoin Keating Quality Engineer Parkmore Business Park West Galway, H91 NHT7 Ireland
Re: K180688
Trade/Device Name: SLENDERTONE CoreFit Abs 8, Type 734 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: September 12, 2018 Received: September 24, 2018
Dear Eoin Keating:
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.
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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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Vivek J. Pinto -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180688
Device Name SLENDERTONE® CoreFit Abs 8, Type 734
Indications for Use (Describe)
The SLENDERTONE® CoreFit Abs 8, Type 734 is indicated for the improvement of abdominal muscle tone, for strengthening of abdominal muscles, and for the development of a firmer abdomen.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the logo for BIO-MEDICAL Research Limited. The logo consists of a cluster of green and blue circles on the left side. To the right of the circles is the text "BIO-MEDICAL" in a light blue color, with the words "Research Limited" underneath in gray.
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.
I. SUBMITTER
| Name: | Mike Kilkelly |
|---|---|
| Address: | Bio-Medical Research Ltd.,Parkmore Business Park West,Galway, IRELAND |
| Telephone: | +353 91 774395 |
| Fax: | +353 91 774301 or +353 91 774302 |
| E-Mail: | mkilkelly@bmr.ie |
| Prepared: | September 21, 2018 |
II. DEVICE
| Trade Name of Device: | SLENDERTONE® CoreFit Abs 8, Type 734 |
|---|---|
| Common Name: | Powered muscle stimulator |
| Regulation Number: | 21 CFR 890.5850 |
| Regulation Description: | Stimulator, muscle, powered, for muscle conditioning |
| Product Code: | NGX |
| Device Class: | 2 |
III. PREDICATE DEVICES
| 510(k) Number: | K100320 (Primary Predicate) |
|---|---|
| Manufacturer: | Bio-Medical Research Ltd. |
| Trade Name: | Slendertone System Ultra, Type 390, Model E70/X70 |
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IV. DEVICE DESCRIPTION
The SLENDERTONE® CoreFit Abs 8, Type 734 is a portable neuromuscular electrical stimulator intended to deliver electrical stimulation to the abdominal muscles. The device includes a control unit, abdominal garment, 3 adhesive gel pads (electrodes), USB cable and instructions for use. It contains ten pre-installed programs.
The control unit is connected to the abdominal belt garment via three magnetic connectors. The control unit contains the primary controls for operation of the device and push buttons are available for switching the unit on off and to increase or decrease the stimulation intensity. The SLENDERTONE® CoreFit Abs 8. Type 734 contains an Organic Light-Emitting Diode (OLED) display which indicates status relating to battery charge and stimulation. Power is derived from a 3.7V Li-Po rechargeable battery pack and the unit can be recharged by using the supplied USB cable.
The SLENDERTONE® CoreFit Abs 8, Type 734 is rated as IP22 for ingress protection. The user has no access to the wiring or connectors within the garment. For purposes of hygiene, the garment may be cleaned and instructions for garment care are included in the user manual.
V. INDICATIONS FOR USE
The SLENDERTONE® CoreFit Abs 8, Type 734 is indicated for the improvement of abdominal muscle tone, for strengthening of abdominal muscles, and for the development of a firmer abdomen. SLENDERTONE® CoreFit Abs 8, Type 734 is intended for over-the-counter use.
The Indications for Use statement for the SLENDERTONE® CoreFit Abs 8, Type 734 is identical to the predicate device
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VI. BIOCOMPATIBILITY EVALUATION
The SLENDERTONE® CoreFit Abs 8, Type 734 uses the same adhesive gel pads (electrodes) as the predicate device Slendertone System Ultra.
Biocompatibility testing of the SLENDERTONE® CoreFit Abs 8, Type 734 garment assembly was carried out. The four test studies conducted were as follows;
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- Cytotoxicity Test: MTT Method MEM with 10% FBS Extract
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- Cytotoxicity Test: MTT Method MEM Extract
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- Skin sensitization: Buehler test in guinea pigs
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- Skin irritation Test: Direct contact.
A summary of the four biocompatibility tests carried out can be seen in the below table.
| Test | Result | Toxicological Conclusion |
|---|---|---|
| Cytotoxicity Test: MTTMethod MEM with 10%FBS Extract | Potential toxicity at extractconcentration >=75% | No toxicological risk to users. |
| Cytotoxicity Test: MTTMethod MEM Extract | No potential cytotoxic potential | No toxicological risk to users. |
| Skin sensitization:Buehler test in guineapigs | Dermal scoring using theMagnusson and Kligman scoringsystem was graded as 0 (novisible change) | No toxicological risk to users. |
| Skin irritation Test: Directcontact | No abnormal signs were observedduring the study. The response ofskin on test side did not exceedthat on the control side. | No toxicological risk to users. |
VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The following table summarizes the similarities and differences between the technological characteristics of the new device and primary predicate device Slendertone System Ultra.
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Image /page/6/Picture/1 description: The image shows the logo for BIO-MEDICAL Research Limited. The logo consists of a circular cluster of green and blue dots on the left. To the right of the dots, the words "BIO-MEDICAL" are written in a light blue font, with "Research Limited" written in gray underneath.
| Table I | New Device | Predicate Device |
|---|---|---|
| Basic Unit Characteristics | SLENDERTONE® CoreFit Abs 8,Type 734 | Slendertone System Ultra,Type 390, Model E70/X70 |
| 1. 510(k) Number | (To be Assigned) | K100320 |
| 2. Device Name, Model | SLENDERTONE® CoreFit Abs 8,Type 734 | Slendertone System UltraType 390, E70/X70 |
| 3. Manufacturer (Contract) | China Turnkey Solutions Logistics(Shenzhen) Co.,Futian Free Trade ZoneCHINA 518038 | China Turnkey Solutions Logistics(Shenzhen) Co.,Futian Free Trade ZoneCHINA 518038 |
| 4. Power Source | 3.7V Lithium Polymer Single CellRechargeable | 3.6V NiMh Battery PackRechargeable |
| - Method of line Isolation | No line connection possible when connectedto body | No line connection possible when connectedto body |
| - Patient Leakage Current | Not applicable, no line connection, no ACcharger connection or operation. Connectionmethod does not allow AC chargerconnection to Patient. | Not applicable, no line connection, no ACcharger connection or operation. Connectionmethod does not allow AC chargerconnection to Patient. |
| 5. No. of Output Modes | 1 (Symmetric, Pulsed, Biphasic) | 1 (Symmetric, Pulsed, Biphasic) |
| 6. Number of Output Channels | 2 | 2 |
| - Synchronous/Alternating? | Synchronous | Synchronous |
| - Method of channel isolation | Transistor | Transistor |
| 7. Regulated Current or Regulated Voltage | Constant Current | Constant Current |
| 8. Software/Firmware/Microprocessor Control? | Yes | Yes |
| 9. Automatic overload Trip? | Yes | Yes |
| 10. Automatic No-Load Trip? | Yes | Yes |
| 11. Automatic Shut Off | Yes | Yes |
| 12. Patient Override Control? | Yes, pause button stops treatmentimmediately. | Yes, pause button stops treatmentimmediately. |
| 13. Indicator Display- On/Off Status? | Yes OLED Display | Yes LCD |
| New Device | Predicate Device | |
| Table IBasic Unit Characteristics | SLENDERTONE® CoreFit Abs 8,Type 734 | Slendertone System Ultra,Type 390, Model E70/X70 |
| - Low Battery? | Yes, OLED Display | Yes, LCD |
| - Voltage/Current Level? | Yes, OLED Display | Yes, LCD |
| 14. Timer range (minutes) | 20-40 minutes | 20-40 minutes |
| 15. Compliance with Voluntary Standards? | IEC 60601-1: 2005 & A1:2012IEC 60601-2-10:2012EN 60601-1-2: 2007IEC 60601-1-11:2010IEC 60601-1-6:2010IEC 62133:2012FCC (47 CFR Part 15, Subpart B) | IEC 60601-1:1988 & A1:1991, A2:1995IEC 60601-2-10:1987 & A1 2001IEC 60601-1-2:2001 (EN 60601-1-2:2001)CISPR 22:2003/CFR 47 Part 15:2005IEC 60601-1-6:2004 (EN 60601-1-6:2001)Battery Charger: IEC 60950 and UL 1950FCC Rules Subpart B |
| 16. Compliance with CFR 21 898? | Yes | Yes |
| 17. Weight (unit) | 37g (incl. batteries) | 116g (inc. batteries) |
| 18. Dimensions (un.){W x H x D} | 57 x 57 x 15 mm approx. | 60 x 23 x 115mm approx. |
| 19. Housing Materials and Construction | Injection moulded thermosetting plastic, with a thermoplastic elastomer (TPE) keypad | Injection moulded thermosetting plastic |
| Table IIOutput Characteristics | New DeviceSLENDERTONE® CoreFit Abs 8,Type 734 | Predicate DeviceSlendertone System Ultra,Type 390, Model E70/X70 |
| Waveform | Pulsed, Symmetrical, Biphasic | Pulsed, Symmetrical, Biphasic |
| Shape | Rectangular, with interphase interval | Rectangular, with interphase interval |
| Maximum Output Voltage (RMSV) (+/- 10%) | 7.58V @ 500Ω14.4V @ 2kΩ@ 10kΩ: no output for 10kΩ resistance | 7.4V @500Ω15.4V@2kΩ6.2V@10kΩ |
| $\frac{Vp^2 x 2 x PW}{\sqrt{\frac{1}{freq}}}$ | ||
| Maximum Output Current (RMSA) (+/- 10%) | 15.16mA @ 500Ω7.2mA @ 2kΩ@ 10kΩ: no output for 10kΩ resistance | 14.7mA@500Ω7.7mA@2kΩ620μA @ 10kΩ |
| Pulse Width | 730 µs | 730 µs |
| Baseline to peak current @500Ω | 72mA | 70mA |
| Frequency (Hz) | 50-70 Hz | 50-70 Hz |
| For interferential modes:- Beat Frequency | N/A | N/A |
| For multiphasic waveforms only:- Symmetrical phases | Yes | Yes |
| - Phase Duration | 200 - 315µs | 200/225/250/275/300/315 µs |
| Net Charge (µC per pulse) | 0@500ΩSymmetric, biphasic and leading polarity alternatesfor each successive pulse | 0@500ΩSymmetric, biphasic and leading polarity alternatesfor each successive pulse |
| Maximum Phase Charge (µC) | 1 phase 22.8 µC @500Ω2 phase 45.6 µC @500Ω | 1 phase 22 µC @500Ω2 phase 44 µC @500Ω |
| C= Ip*PW | ||
| Maximum Current Density (mA/cm²) | 0.216 mA/cm² @500Ω | 0.21 mA/cm² @ 500Ω |
| Table IIOutput Characteristics | New DeviceSLENDERTONE® CoreFit Abs 8,Type 734 | Predicate DeviceSlendertone System Ultra,Type 390, Model E70/X70 |
| Maximum Power Density (W/ cm²)Using smallest electrode conductivesurface area | 1.64 mW/ cm² @500Ω | 1.59 mW/ cm² @500Ω |
| Contraction Time | 1.0 - 5.5 s | 1.0 - 5.5 s |
| Relaxation Time | 1.0 - 7.0 s | 1.0 - 7.0 s |
| Burst Mode | N/A | N/A |
| Additional Features (if applicable) | N/A | N/A |
| Maximum Charge Current | 300mA @ 5V | 400 mA @ 6V |
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Image /page/10/Picture/1 description: The image is a company logo for Bio-Medical Research Limited. The logo consists of a cluster of green and blue circles on the left side. To the right of the circles, the words "BIO-MEDICAL" are written in a light blue font, with the words "Research Limited" written below in a gray font.
VII. PERFORMANCE DATA
Performance testing was conducted in accordance with the following international standards for safety:
| IEC 60601-1: 2005/A1:2012 | Medical electrical equipment. General requirements for basic safety and essential performance |
|---|---|
| IEC 60601-1-6:2010/A1:2013 | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
| IEC 60601-1-2:2007 | Medical electrical equipment - part 1-2: general requirements for safety -collateral standard: electromagnetic compatibility - requirements and tests |
| IEC 60601-2-10:2012 | Medical Electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators |
| IEC 60601-1-11:2015 | Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
Battery testing was conducted in accordance with IEC 62133:2012 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells and for batteries made from them, for use in portable applications.
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VIII. CONCLUSION
- The SLENDERTONE® CoreFit Abs 8, Type 734 has the same principles of . operation as it's predicate device and any differences in technological characteristics do not raise new issues of safety or effectiveness.
- The Indications for Use statement is identical to the predicate device. .
- Performance data has demonstrated that the SLENDERTONE® CoreFit Abs 8, . Type 734 is as safe and effective as the predicate device and is substantially equivalent.
§ 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).