(444 days)
TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.
EMS: The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
Perfect EMS is a hand-held, home-use device designed to relief of pain and improve and facilitate muscle performance. Perfect EMS is intended for over-the-counter use.
The device is battery powered, two channels home use neuromuscular stimulation. The device is supplied with self-adhesive electrodes which connect to the control unit by cable and plug and are placed on patients' intact skin by the end user. Electrical stimulation is delivered via self-adhesive electrodes to nerves and muscles.
The level of electrical stimulation is easily controlled by the end user using manual, pushbutton controls.
The unit is intended for home use by the patient, and is designed with simplicity and ease of use in mind. It has six preset treatment programs and four manually adjustable programmes are available.
Accessories: 2 x 1.25m PVC Lead Wires (L-CPT) 50x50mm hydrogel electrode pads (E-CM5050)
Optional accessories: 50x100mm Large hydrogel electrode pads Pack of 4 (E-CM50100)
The provided text describes a 510(k) submission for the Perfect EMS device, asserting its substantial equivalence to a predicate device (HIVOX OTC Electrical Stimulator Model: EM49-2, K190347). The document focuses on demonstrating that the Perfect EMS meets safety and performance criteria by comparing it to the predicate and through compliance with recognized standards.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Perfect EMS device are implicitly defined by its substantial equivalence to the predicate device, EM49-2 (K190347), and adherence to a battery of safety and performance standards. The table above the horizontal line below summarizes the performance attributes of the Perfect EMS (Subject Device) and the predicate device, along with the comparison stating "Substantially equivalent" or "Identical."
| Attribute | Acceptance Criteria (Implicitly from Predicate/Standards) | Reported Device Performance (Perfect EMS) | Comparison Conclusion |
|---|---|---|---|
| Product Code | NUH, NGX | NUH, NGX | Identical; Substantially equivalent |
| Regulation No. | 21 CFR 882.5890; 21 CFR 890.5850 | 21 CFR 882.5890; 21 CFR 890.5850 | Identical; Substantially equivalent |
| Indications for Use | Same as predicate (TENS: temporary pain relief for sore/aching muscles; EMS: stimulate healthy muscles for improved performance) | Same as predicate | Same indications for use; Substantially equivalent |
| Prescriptive or OTC | OTC | OTC | Identical; Substantially equivalent |
| Number of output modes | Within acceptable range compared to predicate (predicate had 70 modes) | 10 | Substantially equivalent |
| Number of output channels | 2 | 2 | Substantially equivalent |
| Timer (minutes) Range | Adjustable, comparable to predicate (predicate 5-100 mins) | Default 20 mins, Adjustable to 10, 20, 30, 45, 60, 90 minutes | Both are adjustable; Substantially Equivalent |
| Regulated Current or Regulated Voltage? | None | None | Substantially Equivalent. |
| Software/Firmware/Microprocessor Control? | Yes | Yes | Identical control method |
| Automatic No-Load Trip? | Yes | Yes | Identical |
| Automatic Overload Trip? | Yes | Yes | Identical |
| Automatic Shut Off? | Yes | Yes | Identical |
| User Override Control? | Yes | Yes | Substantially Equivalent. |
| Indicator Display: On/Off status | Yes | Yes | Identical |
| Indicator Display: Low battery | Yes | Yes | Identical |
| Indicator Display: Voltage/Current level | Yes | Yes | Identical |
| Indicator Display: Time to cut-off | Yes | Yes | Identical |
| Frequency (Hz) | Within acceptable range compared to predicate (predicate 1-150Hz) | 1-120Hz | Substantially equivalent |
| Pulse Width (µs) | Within acceptable range compared to predicate (predicate 50-450µs) | 50-350µs | Substantially equivalent |
| Waveform | Bi-phasic | Bi-phasic | Identical |
| Shape | Rectangular | Rectangular | Identical |
| Maximum Output Voltage (V) | 50V@ 500Ω | 50V@ 500Ω | Substantially equivalent |
| Maximum Output Current (mA) | 100mA@ 500Ω | 100mA@ 500Ω | Substantially equivalent |
| Maximum Phase Charge (µC) | Within acceptable range compared to predicate (predicate 37.6µC@ 500Ω) | 20.5µC@ 500Ω | Substantially equivalent |
| Maximum Current Density, (mA/cm²) | Safe levels, compared to predicate (predicate 0.07426mA/cm²@ 500Ω) | 0.01013mA/cm²@ 500Ω (Area=25cm²) | Substantially equivalent |
| Maximum Power Density, (W/cm²) | Safe levels, less than 0.25 W/cm² (predicate 0.0066W/cm²@ 500Ω) | 0.00053W/cm²@ 500Ω (Area=25cm²) | Substantially equivalent |
| Power Source | Internal power supply (predicate used AAA batteries) | 2 Alkaline AA 1.5V Batteries | Both are internal power supply source: Substantially equivalent |
| Weight | Comparable to predicate (predicate 83g) | 75 g without batteries | Substantially Equivalent. |
| Dimensions (mm) [W x H x D] | Comparable to predicate (predicate 132 x 63 x 29.5 mm) | 120 x 60 x 31mm | Substantially Equivalent. |
| Housing Materials and Construction | Safe and effective (predicate ABS plastics) | Silicone, ABS plastics | Substantially Equivalent. |
| Electrode lead wires and patient cable | Yes (PVC) | Yes (PVC and nylon yarn) | Substantially equivalent |
| Compliance with Voluntary Standards | Yes | Yes (See section 1.3/VII for specific standards) | Substantially equivalent |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of clinical data or patient outcomes. The performance evaluation is based on engineering and safety testing against recognized standards. Therefore, information regarding sample size and data provenance for a test set in the traditional sense (e.g., patient data) is not applicable here. The provenance for the device is the manufacturing facility in China (EasyMed Instruments Co Ltd).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The evaluation framework is based on compliance with established engineering and safety standards, and a comparison to a predicate device. There is no mention of human expert-established "ground truth" for the performance tests conducted on the device's technical specifications.
4. Adjudication method for the test set
This information is not applicable. As there is no clinical "test set" requiring human interpretation or decision-making, an adjudication method for such a set is not relevant.
5. 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
An MRMC study is relevant for evaluating the performance of AI-assisted diagnostic or decision-making systems. The Perfect EMS is an electrical stimulator for pain relief and muscle performance, not an AI diagnostic tool. Therefore, an MRMC comparative effectiveness study is not applicable and was not reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The Perfect EMS is a physical medical device, not a software algorithm. Therefore, "standalone (algorithm only without human-in-the-loop performance)" is not applicable. Performance was assessed by measuring the device's electrical output and adherence to safety standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is the pre-defined acceptance criteria set by recognized safety and performance standards (e.g., ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10, IEC 62304, ISO 10993-1) and the technical specifications of the legally marketed predicate device (EM49-2 K190347). The device's performance was measured against these established quantitative parameters and qualitative design characteristics.
8. The sample size for the training set
This information is not applicable. The Perfect EMS is a hardware device; it does not explicitly mention any machine learning or AI components that would require a "training set" for an algorithm.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8. There is no mention of a training set or AI algorithm in this context.
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Image /page/0/Picture/0 description: The image shows 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.
June 4, 2021
TensCare Ltd. Andrew Brown Quality Manager 9 Blenheim Road, Longmead Business Park Epsom, Surrey KT19 9BE United Kingdom
Re: K200694
Trade/Device Name: Perfect EMS Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: May 1, 2021 Received: May 17, 2021
Dear Andrew Brown:
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 con tract 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
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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/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, Sub part 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,
Heather Dean, PhD Assistant Director. Acute Injurv Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200694
Device Name Perfect EMS
Indications for Use (Describe)
TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.
EMS: The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
| 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) | X |
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510(k) Summary
K200694
Date of Subimission prepared: March 5, 2020
| Submitter : | Tenscare Ltd |
|---|---|
| Address: | 9 Blenheim Road, Longmead Business Park, Epsom,Surrey, KT19 9BE, United Kingdom |
| Tel : | +44(0)1372 723 434 |
| Fax : | +44(0)1372 745 434 |
| E-Mail : | andrew@tenscare.co.uk |
| FDA EstablishmentRegistration No: | 3003446042 |
| Contact person: | Andrew Brown |
Address of the manufacturing facility:
EasyMed Instruments Co Ltd 3/F, 5F/6F, Block A, Gupo Gongmao Building, Fengxin Road, Fengxiang Industrial District, Daliang, 528300 Shunde, Foshan, Guangdong, China,
FDA Establishment Registration No: 3004049909
Address of American Representative:
| Contact First Name; | SCOTT A |
|---|---|
| Contact Last Name: | BEDNAR |
| Title: | MR |
| Business Name: | QA/RA CONSULTING GROUP, INC. |
| Full Address: | 3335 TUSCARAWAS ROADBEAVER, PENNSYLVANIA, 15009, UNITED STATES |
| E-mail: | sbednar@qaraconsultinggroup.com |
| Phone Number: | 412-4188066 |
ll Submitted Device:
| Trade name: | Perfect EMS |
|---|---|
| Common name: | Transcutaneous Electrical Nerve Stimulator (TENS) /Electrical Muscle Stimulator (EMS) |
| Classification Number: | 21 CFR 882.5890;21 CFR 890.5850 |
| Classification name: | Transcutaneous electrical nerve stimulator for pain relief;Powered muscle stimulator |
| Product Code: | NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter);NGX (Stimulator, Muscle, Powered, For Muscle Conditioning) |
| Classification Panel: | Neurology; Physical Medicine |
| Regulatory Class: | Class II |
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��� Predicate Device:
| Predicate Device: | HIVOX OTC Electrical Stimulator |
|---|---|
| Trade/Device Name: | EM49-2 |
| Model Number: | HIVOX BIOTEK INC. |
| Manufacturer: | K190347 |
| 510(k) Number: | NUH, NGX |
| Product Code: | Over-The-Counter Use (OTC Use |
| Type of Use: | Class II |
| Regulatory Class: |
Device Description: IV
Perfect EMS is a hand-held, home-use device designed to relief of pain and improve and facilitate muscle performance. Perfect EMS is intended for over-the-counter use.
The device is battery powered, two channels home use neuromuscular stimulation. The device is supplied with self-adhesive electrodes which connect to the control unit by cable and plug and are placed on patients' intact skin by the end user. Electrical stimulation is delivered via self-adhesive electrodes to nerves and muscles.
The level of electrical stimulation is easily controlled by the end user using manual, pushbutton controls.
The unit is intended for home use by the patient, and is designed with simplicity and ease of use in mind. It has six preset treatment programs and four manually adjustable programmes are available.
Accessories: 2 x 1.25m PVC Lead Wires (L-CPT) 50x50mm hydrogel electrode pads (E-CM5050)
Optional accessories: 50x100mm Large hydrogel electrode pads Pack of 4 (E-CM50100)
ENVIRONMENT OF USE: Clinics, hospital and home environments
Indications for Use of the device: >
TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.
EMS: The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
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The Perfect EMS is intended for OTC use.
The indications for use of the Perfect EMS are the same as those of the predicate device HIVOX OTC Electrical Stimulator Model: EM49-2 (K190347).
VI Equivalence Comparison to the Predicate Devices:
Electrical nerve and muscle stimulation is the technological principle for both the Perfect EMS and the predicate device EM49-2 (K190347).
The technical characteristics of Perfect EMS are similar to those of the predicate device in design, intended use and function. The predicate device EM49-2 (K190347) and the Perfect EMS are devices apply an electrical current via electrodes to a patient's nerves and muscles.
The stimulation parameters of Perfect EMS are similar to those of predicate device EM49-2 (K190347). Perfect EMS totally has 10 programs, the parameter of Perfect EMS are all in the same range of those of predicate device EM49-2 (K190347).
Table 1 below summarizes the shared and unique technological elements between the Perfect EMS and EM49-2 (K190347). The technology, engineering, and performance for Perfect EMS are substantially equivalent to the predicate device.
From the view of safety and effectiveness, the output characteristics of Perfect EMS are similar to those of predicate device EM49-2 (K190347), see Table 1. The Perfect EMS is designed to comply with relevant safety applicable recognized consensus standards: the output energy is controlled well within the safety and effectiveness ranges specified by relevant FDA guidance. Detailed and strictly controlled testing has been carried out. The maximum power density of Perfect EMS is less than 0.25 watts per square centimeter of electrode conductive surface area to reduce the risk of thermal burns. Furthermore, Test results, Risk Analysis, and FMEA analysis show that the Perfect EMS is safe with no hazard.
As such:
-
the Perfect EMS has similar technological characteristics and intended uses as the predicate EM49-2 (K190347): and
-
the information submitted to the FDA for the Perfect EMS does not raise new questions about safety or effectiveness and demonstrates with reasonable assurance based on established controls that the device is at least as safe and effective as a legally marketed device.
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Table 1 Substantial Equivalence Comparison Table
| Attribute | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| Product Name | Perfect EMS | EM49-2 | |
| 510(K) number | K200694 | K190347 | |
| Product Code | NUH, NGX | NUH, NGX | Identical codes;Substantiallyequivalent |
| Regulation No. | 21 CFR 882.5890;21 CFR 890.5850 | 21 CFR 882.5890;21 CFR 890.5850 | Identical;Substantiallyequivalent |
| Manufacturer | TensCare Ltd | HIVOX BIOTEK INC. | |
| Indicationsfor Use | TENS: The device isdesigned to be used fortemporary relief of painassociated with sore andaching muscles in theshoulder, waist, back, neck,upper extremities (arm),lower extremities (leg),abdomen and bottom due tostrain from exercise or normalhousehold work activities.EMS: The device is designedto be used for stimulatehealthy muscles in order toimprove and facilitate muscleperformance. | TENS: The device isdesigned to be used fortemporary relief of painassociated with sore andaching muscles in theshoulder, waist, back, neck,upper extremities (arm),lower extremities (leg),abdomen and bottom due tostrain from exercise ornormal household workactivities.EMS: The device is designedto be used for stimulatehealthy muscles in order toimprove and facilitate muscleperformance. | Same indicationsfor use;Substantiallyequivalent |
| Prescriptive or OTC | OTC | OTC | Identical;Substantiallyequivalent |
| Numberofoutputmodes | 10 | 70* | Substantiallyequivalent |
| Numberofoutputchannels | 2 | 2* | Substantiallyequivalent |
| Timer(minutes)Range | Default 20 minutes.Adjustable to 10, 20, 30, 45,60, 90 minutes | Default 30 minutes.Adjustable from 5 to 100minutes* | Both areadjustable;SubstantiallyEquivalent |
| Regulated Current orRegulated Voltage? | None | None* | SubstantiallyEquivalent. |
| Attribute | Subject Device | Predicate Device | Comparison |
| Software/Firmware/MicroprocessorControl? | Yes | Yes * | Identical controlmethod |
| AutomaticNo-LoadTrip? | Yes | Yes* | Identical |
| AutomaticOverloadTrip? | Yes | Yes* | Identical |
| Automatic Shut Off? | Yes | Yes* | Identical |
| User OverrideControl? | Yes | Yes* | SubstantiallyEquivalent. |
| Indicator Display:-On/Off status | Yes | Yes* | Identical |
| -Low battery | Yes | Yes* | |
| -Voltage/Current level | Yes | Yes* | |
| -Time to cut-off | Yes | Yes* | |
| Frequency (Hz) | 1-120Hz | 1-150Hz* | Substantiallyequivalent |
| Pulse Width (μs) | 50-350μs | 50-450μs* | Substantiallyequivalent |
| Waveform | Bi-phasic | Bi-phasic* | Identical |
| Shape | Rectangular | Rectangular* | Identical |
| Maximum OutputVoltage (V) | 50V@ 500Ω | 50V@ 500Ω* | Substantiallyequivalent |
| Maximum OutputCurrent (mA) | 100mA@ 500Ω | 100mA@ 500Ω* | Substantiallyequivalent |
| Maximum PhaseCharge (μC) | 20.5μC@ 500Ω | 37.6μC@ 500Ω* | Substantiallyequivalent |
| Maximum CurrentDensity, (mA/cm²) | 0.01013mA/cm²@ 500Ω(Area=25cm²) | 0.07426mA/cm²@ 500Ω*(Area=20.25cm²) | Substantiallyequivalent |
| Maximum PowerDensity, (W/cm²) | 0.00053W/cm²@ 500Ω(Area=25cm²) | 0.0066W/cm²@ 500Ω*(Area=20.25cm²) | Substantiallyequivalent |
| Power Source | 2 Alkaline AA 1.5V Batteries | 3 Alkaline AAA 1.5VBatteries | Both are internal power supplysource:Substantiallyequivalent |
| Weight | 120 x 60 x 31mm | 132 x 63 x 29.5 mm* | SubstantiallyEquivalent. |
| Dimensions (mm) [Wx H x D] | 75 g without batteries | 83 g without batteries* | SubstantiallyEquivalent. |
| Housing Materialsand Construction | Silicone, ABS plastics | ABS plastics * | SubstantiallyEquivalent. |
| Electrode lead wiresand patient cable | Yes(PVC and nylon yarn) | Yes*PVC | Substantiallyequivalent |
| Attribute | Subject Device | Predicate Device | Comparison |
| compliance with 21CFR 898 | |||
| CompliancewithVoluntary Standards | YesSee section 1.3 | Yes*See section 1.3 | Substantiallyequivalent |
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Remark: The information marks with * means the information is not publicly available
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VII Performance Tests:
A series of safety and performance tests were conducted on the subject device Perfect EMS See below:
| FDA recognition No. | Standard Title |
|---|---|
| 19-4 | ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012,C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text)Medical electrical equipment - Part 1: General requirements forbasic safety and essential performance (IEC 60601-1:2005, MOD) |
| 19-8 | IEC 60601-1-2 Edition 4.0 2014-02Medical electrical equipment - Part 1-2: General requirements forbasic safety and essential performance - Collateral Standard:Electromagnetic disturbances - Requirements and tests |
| 19-14 | IEC 60601-1-11 Edition 2.0 2015-01Medical electrical equipment - Part 1-11: General requirements forbasic safety and essential performance - Collateral Standard:Requirements for medical electrical equipment and medicalelectrical systems used in the home healthcare environment. |
| 17-16 | IEC 60601-2-10 Edition 2.1 2016-04Medical electrical equipment - Part 2-10: Particular requirements forthe basic safety and essential performance of nerve and musclestimulators |
| 13-79 | IEC 62304 Edition 1.1 2015-06 CONSOLIDATEDVERSION Medical device software - Software life cycle processes |
| 2-220 | ANSI AAMI ISO 10993-1:2009/(R)2013Biological evaluation of medical devices - Part 1: Evaluation andtesting within a risk management processThree biocompatibility tests conducted:Cytotoxicity (per ISO 10993-5)-Sensitization (per ISO 10993-10)-Irritation (per ISO 10993-10)- |
All the test results demonstrate Perfect EMS meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate device.
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VII Conclusion:
- � The Perfect EMS has the same technological characteristics and intended uses as the predicateEM49-2 (K190347); and
- � The labelling of the Perfect EMS is concordant with the predicate device and FDA requirements; and
- � The information submitted to the FDA for the Perfect EMS does not raise new questions about safety or effectiveness and demonstrates with reasonable assurance based on established controls that the device is at least as safe and effective as a legally marketed device.
Therefore, the Perfect EMS is substantially equivalent to the predicate device.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).