(204 days)
WIEMSPRO is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The WIEMSPRO is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of WIEMSPRO training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated.
WIEMSPRO is a machine with electronic muscle stimulation based on EMS technology. Regarding is specifically designed as an addition to other sports and for training muscles. It must be used for only healthy muscles and clients, not for rehabilitation purposes.
WIEMSPRO electrical impulses allow the triggering of action potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones are transmitted to the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration, duration, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.
The device described in this submission is an electro-medical device intended for stimulating healthy muscles in order to improve or facilitate muscle performance. It is designed for personal training performances.
WIEMSero is a device with electronic muscle stimulation based on EMS technology. Regarding its use, the device is specifically designed as an addition to other sports and for training muscles. It must be used for only healthy muscles and clients, not for rehabilitation purposes. The device must be used over user's cotton undergarments and is therefore not patient-contacting
WIEMSPRO system cannot be used while the user is in motion or lifting weights.
The provided document is an FDA 510(k) premarket notification for the WIEMSPRO device, a powered muscle stimulator. It focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving a specific performance metric against acceptance criteria through a clinical study for an AI/ML powered device.
Therefore, the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment, which are typical for clinical validation of AI/ML devices, is not present in this document.
The document discusses bench testing to determine conformance to performance specifications and requirements, particularly for electrical safety, electromagnetic compatibility, and FCC radio frequency testing. It states that "No clinical studies are submitted."
Given the document's content, here's an attempt to answer the questions based on what is provided and to highlight what information is missing:
Acceptance Criteria and Device Performance (Based on Technical Specifications and Bench Testing)
Since this is a 510(k) for a powered muscle stimulator, the "acceptance criteria" discussed are primarily related to meeting established electrical and safety standards for this class of device, and demonstrating equivalence to predicate devices based on technical characteristics. There isn't an explicit table of "AI performance metrics" and their acceptance thresholds as would be common for AI/ML device submissions.
The device performance is reported implicitly by stating compliance with various IEC and FCC standards, and noting the technical specifications in comparison to predicate devices.
Table of "Acceptance Criteria" (Implied by Compliance and Equivalence) and Reported Performance:
| Implied "Acceptance Criteria" Category | Specific Criteria (Based on Standards & Comparison) | Reported Device Performance / Compliance |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1 (general requirements for basic safety and essential performance of medical electrical equipment), IEC 60601-2-10 (particular requirements for nerve and muscle stimulators), and related standards (e.g., ANSI/AAMI ES60601-1). This includes aspects like patient leakage current, power source safety, and automatic shut-off mechanisms. | - Passed "bench testing to determine conformance to performance specifications and requirements taking account of its intended use."- "Electrical safety (including particular requirements for the basic safety and essential performance of nerve and muscle stimulator and for medical electrical equipment)" was performed and showed correct operation.- Complies with IEC 60601-1-2:2007, IEC 60601-2-10:2012, IEC 60601-1-6 Edition 3.1 2013-10, ANSI/AAMI ES60601-1:2005 / A2:2010. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 (requirements for electromagnetic compatibility of medical electrical equipment) and FCC Part 15 (unintentional radiators). | - "Electromagnetic compatibility" testing was performed and showed correct operation.- Complies with IEC 60601-1-2:2007 and FCC 47 CFR Part 15 §15.107 and §15.109. |
| Software Life Cycle Processes | Compliance with IEC 62304 (medical device software – software life cycle processes). | - Complies with IEC 62304:2006. |
| Risk Management | Compliance with ISO 14971 (application of risk management to medical devices). | - Complies with ISO 14971:2007. |
| Technical Equivalence to Predicates | WIEMSPRO's technological characteristics (e.g., classification, product code, regulation number, panel, class, intended use, power source, output modes, current/voltage, waveform, safety features) should be substantially equivalent to the predicate devices (E-Fit EF-1280 and Compex WirelessUSA) or any differences should not affect safety and effectiveness. | - Comparison table provided, indicating "Same" or "Similar" for most characteristics.- Notable differences (e.g., higher max output current, but lower current density compared to one predicate; absence of TENS function present in one predicate) are argued not to affect safety and effectiveness. "Maximum output current value is higher... however maximum output current density... is much lower than that of Compex Wireless USA... none of the differences spotted impact the equivalence..." |
Study Details (Information Not Applicable or Not Provided for this Device Type/Submission)
The following points are primarily relevant for AI/ML device submissions involving clinical performance evaluation, which is not the nature of this 510(k) submission.
- Sample sizes used for the test set and the data provenance:
- Not Applicable / Not Provided. This document describes "bench testing" for electrical safety and EMC, and a comparison to predicate devices, not a clinical study with a test set of patient data for AI performance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No clinical test set requiring expert-established ground truth is detailed.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No clinical test set requiring adjudication is detailed.
- 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:
- Not Applicable / No. This device is a muscle stimulator, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed or described.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not an AI algorithm. Its performance is evaluated through engineering and safety standards, not standalone algorithmic performance.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc.):
- Not Applicable. For the bench testing, the "ground truth" would be established engineering standards and test procedures for electrical and electromagnetic performance.
- The sample size for the training set:
- Not Applicable. This is not an AI/ML device that undergoes training on a data set.
- How the ground truth for the training set was established:
- Not Applicable. No training set exists for this device.
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February 12, 2019
Medical Cables, S.L. José Fuertes Peña Manager Duque de la Victoria 6, 1º Malaga, Spain 29015
Re: K181955
Trade/Device Name: WIEMSPRO Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: December 18, 2018 Received: January 16, 2019
Dear José Fuertes Peña:
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) K181955
Device Name WIEMSPRO
Indications for Use (Describe)
WIEMSPRO is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The WIEMSPRO is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of WIEMSPRO training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated.
WIEMSPRO is a machine with electronic muscle stimulation based on EMS technology. Regarding is specifically designed as an addition to other sports and for training muscles. It must be used for only healthy muscles and clients, not for rehabilitation purposes.
WIEMSPRO electrical impulses allow the triggering of action potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones are transmitted to the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration, duration, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.
| 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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510(k) Premarket medicalcables WIEMSpro Notification DATE OF SUBMISSION: 2018-03-02 SUBMITTER NAME: Medical Cables, S.L. SUBMITTER ADDRESS: Duque de la Victoria 6, 1º 29015, Malaga SPAIN CONTACT: José Fuertes Peña TELEPHONE: +34 95 221 89 91 E-mail: ifuertes@medicalcables.eu DEVICE TRADE NAME: WIEMSpro COMMON NAME: Powered muscle stimulator. Stimulator, Muscle, Powered, For Muscle Conditioning CLASSIFICATION NAME: (21 CFR 890.5850) E-Fit EF-1280 (K133225) PREDICATE DEVICE(S): Compex Wireless USA (K170903)
DEVICE DESCRIPTION:
The device described in this submission is an electro-medical device intended for stimulating healthy muscles in order to improve or facilitate muscle performance. It is designed for personal training performances.
WIEMSero is a device with electronic muscle stimulation based on EMS technology. Regarding its use, the device is specifically designed as an addition to other sports and for training muscles. It must be used for only healthy muscles and clients, not for rehabilitation purposes. The device must be used over user's cotton undergarments and is therefore not patient-contacting
WIEMSPRO system cannot be used while the user is in motion or lifting weights.
SUMMARY OF COMPARISON WITH PREDICATE DEVICE:
In the establishment of substantial equivalence, the WIEMSPRO device is compared with the following previously cleared devices:
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510(k) Premarket Notification
Comparison of the proposed devices with the predicate devices is summarized in the following table:
| COMPARISON OF TECHNOLOGICAL CHARACTERISTICS | ||||
|---|---|---|---|---|
| Characteristic /Feature | PROPOSED DEVICE | PREDICATE DEVICE | PREDICATE DEVICE | Comparison |
| WIEMSPRO | E-Fit EF-1280 | Compex Wireless USA | ||
| GENERAL COMPARISON | ||||
| Classificationname | Powered muscle stimulator | Powered musclestimulator | Powered muscle stimulator | Same |
| Product code | NGX | NGX | NGX | Same |
| Regulationnumber | 21 CFR 890.5850 | 21 CFR 890.5850 | 21 CFR 890.5850 | Same |
| Panel | Physical Medicine | Physical Medicine | Physical Medicine | Same |
| Class | Class II | Class II | Class II | Same |
| 510(K) Number | -- | K133225 | K170903 | N/A |
| INTENDED USE | ||||
| Indication foruse | WIEMSPRO is intended tostimulate healthy muscles inorder to improve or facilitatemuscle performance. TheWIEMSPRO is not intended tobe used in conjunction withtherapy or treatment of medicaldiseases or medical conditionsof any kind. None ofWIEMSPRO training programs isdesigned for injured or ailingmuscles and its use on suchmuscles is contraindicated.WIEMSPRO is a machine withelectronic muscle stimulationbased on EMS technology.Regarding its use, the device isspecifically designed as anaddition to other sports and fortraining muscles. It must beused for only healthy musclesand clients, not forrehabilitation purposes.WIEMSPRO electrical impulsesallow the triggering of actionpotentials on motoneurones ofmotor nerves (excitations).These excitations ofmotoneurones are transmittedto the muscle fibers via themotor endplate where theygenerate mechanical musclefiber responses thatcorrespond to muscle work.Depending on the parametersof the electrical impulses(pulse frequency, duration ofcontraction, duration of rest,total session duration),different types of muscle work | E-fit EF-1280 is a machinewith electronic musclestimulation based on EMStechnology. Regarding itsuse, the device isspecifically designed as anaddition to other sportsand for training muscles. Itmust be used for onlyhealthy muscles andclients, not forrehabilitation purposes.The E-Fit EF-1280intended to stimulatehealthy muscles in order toimprove or facilitatemuscle performance. TheE-Fit EF-1280 is notintended to be used inconjunction with therapy ortreatment of medicaldiseases or medicalconditions of any kind.None of the E-Fit EF-1280training programs isdesigned for injured orailing muscles and its useon such muscles iscontraindicated.The E-Fit EF-1280electrical impulses allowthe triggering of actionpotentials onmotoneurones of motornerves (excitations).These excitations ofmotoneurones aretransmitted to the musclefibers via the motor | The Compex Wireless USA is anOver-The-Counter deviceintended to stimulate healthymuscles in order to improve orfacilitate muscle performance. Itis to be used by adults only.The Compex Wireless USA is notintended for adjunctive therapy inthe treatment of medicaldiseases and conditions of anykind. None of the CompexWireless USA stimulationprograms are designed forinjured or disease afflictedmuscles. Its use on suchmuscles is contraindicated. Thework imposed on the muscles bythe Compex Wireless USAprograms is definitely not suitablefor rehabilitation andphysiotherapy. The CompexWireless USA electrical impulsesallow the triggering of actionpotentials on motoneurones ofmotor nerves (excitations). Theseexcitations of motoneurones aretransmitted to the muscle fibersvia the motor endplate wherethey generate mechanicalmuscle fiber responses thatcorrespond to muscle work.Depending on the parameters ofthe electrical impulses (pulsefrequency, duration ofcontraction, duration of rest, totalsession duration), different typesof muscle work can be imposedon the stimulated muscles. TheCompex Wireless USA maytherefore be considered atechnique of muscle training. | SameWIEMSPROdoes notincludeTENS |
| Intended use | can be imposed on the stimulated muscles. | endplate where theygenerate mechanicalmuscle fiber responsesthat correspond to musclework. Depending on theparameters of theelectrical impulses (pulsefrequency, duration ofcontraction, duration ofrest, total sessionduration), different types ofmuscle work can beimposed on the stimulatedmuscles.The various types ofmuscle work that the E-FitEF-1280 can impose onthe stimulated muscles areable to improve or facilitatemuscle performance. TheE-Fit EF-1280 maytherefore be considered atechnique of muscletraining.Must be used for onlyhealthy muscles andclient. It is not intended tobe used in conjunctionwith therapy or treatmentof medical diseases or | The Compex Wireless USATENS is used for:· temporary relief of painassociated with sore and achingmuscles due to strain fromexercise or normal householdand work activities.· the symptomatic relief andmanagement of chronic,intractable pain and relief of painassociated with arthritis.Must be used for only healthymuscles and client. It is notintended to be used inconjunction with therapy ortreatment of medical diseases ormedical conditions of any kind. | Similar.Differenceis thesoftwareapplicationwhichcontrols thedevice |
| Must be used for only healthymuscles and client. It is notintended to be used inconjunction with therapy ortreatment of medical diseasesor medical conditions of anykind.It is designed to be usedtogether with a WIEMSPROMobile Application. | medical conditions of anykind. | whichcontrols thedevice | ||
| Mobile Application. | TECHNOLOGICAL CHARACTERISTICS AND PERFORMANCE | |||
| Powered Muscle | ||||
| Stimulator | YES | YES | YES | Same |
| Power Source | Battery: 3.7 V – 2,4AH (LiPo) | 12V (3,4Ah) lead Acid | Remote: : LithiumPolymer (LiPo)rechargeable 3.7[V] / ≥1500[mAhStimulation Modules:Lithium Polymer (LiPo)rechargeable 3.7[V] / ≥450[mAh] | Similar |
| Method of linecurrent isolation | N/A (battery operated device) | N/A (battery operateddevice) | N/A (battery operated device) | Same |
| Patient leakage | Same | |||
| current-Normalcondition | N/A (battery operated device)N/A (battery operated device) | N/A (battery operateddevice)N/A (battery operateddevice) | N/A (battery operated device)N/A (battery operated device) | |
| condition-Single fault | N/A (battery operateddevice) | |||
| condition | ||||
| Battery operated | YES | YES | YES | Same |
| Number ofoutput modes | One output mode, but withvarying stimulation frequency | One output mode, but withvarying stimulation | Two (NMES/TENS) | Similar asEfit |
| and duty cycle ranges. | frequency and duty cycleranges | DifferentthanCompexWIEMSPROdoes notincludeTENS | ||
| Regulatedcurrent orregulatedvoltage? | YES, regulated current | YES, regulated current | YES, regulated current | Same |
| Software/Firmware/Microprocessor Control? | YES | YES | YES | Similar asEfit |
| AutomaticOverload Trip? | YES | YES | YES | Similar asCompexSimilar asEfit |
| Automatic No-Load Trip? | YES | YES | YES | Similar asCompexSimilar asEfit |
| Automatic ShutOff? | On/Off switch | On/Off switch | On/Off switch | Same asEfitSame asCompex |
| Patient OverrideControl? | Yes, push on On/Off buttondirectly pause the program | Yes, push on On/Offbutton directly pause theprogram | Yes, push on On/Off buttondirectly pause the program | Same asEfitSame asCompex |
| Indicator display | Yes | Yes | Yes | Same asEfitSame asCompex |
| Device weight | 300 g | N/A | Remote: 110 [g]StimulationModule:2x60 [g]Docking Station 800[g] | Similar asCompex |
| Dimensions (in.)[W x H x D] | [6,66 x 3,27 x 1,18] in | Not available | Not available | Similar asCompexNo exactinformation |
| Waveform (e.g.,pulsedmonophasic,biphasic)(program perprogram) | Symmetrical biphasic (allprograms) | Symmetric Biphasic (allprograms) | -Endurance:Symmetrical Biphasic-Resistance:Symmetrical Biphasic-Strength :Symmetrical Biphasic-Explosive Strength:Symmetrical Biphasic-Potentiation:Symmetrical Biphasic-Training Recovery (sameas Active Recovery):Symmetrical Biphasic-CompetitionRecovery (same asRecovery Plus):Symmetrical Biphasic-Pre-Warmup Program:Symmetrical Biphasic-Muscle Relaxation (sameas Massage):Symmetrical Biphasic-Pain relief TENS (sameas FM): Balanced,asymmetrical Biphasic | frompredicatedevices butnotrelevant forSEdeterminationSimilar asEfitSimilar asCompexNo TENSincluded intheWIEMSPROdevice |
| Number ofprograms | 20 | 5+5 | 22 | Differentthan Efit |
| Current / Voltage | 125mA/62.5V | 72mA/36V | 116mA/60V | Similar asCompexDifferentthan Efit |
| Plastic HousingMaterials | PLASTIC | STAINLESS STEEL | PLASTIC | Similar asCompexThehousing isnot in directcontactwith theclient asused oversportswear |
| Maximum outputvoltage | 170V | 66V-100V | 165V | Similar |
| Maximum outputcurrent | 125mA | 72mA | 116mA | Similar |
| density | ||||
| Maximumcurrent density | 1,92mA/cm2Smallest electrode size: 65 cm2 | 0,85mA/cm² | 3,84mA/cm²Smallest electrode size: 25 cm 2 | Similar |
| Number ofOutput channels | 1 CHANNEL | 1 CHANNEL | 4 CHANNELS | Same asEfit |
| Independentchannels withpossibility toregulate thecurrentindividually | 10 CHANNELS | 12 CHANNELS | 4 CHANNELS | Similar asEfitDifferentthanCompexWIEMSPROonly 1channel |
| Pulse duration(width) | 100-400usec | 100-500usec | 200 or 400usec | Similar |
| Frequency | 1-100 HZ | 5-120 HZ | 1-120 HZ | SimilarSame asEfit |
| Reusable pads | YES | YES | NO | DifferentthanCompex |
| Compliance withvoluntarystandards / LABtests performed | IEC 60601-1-2:2007IEC 60601-1-6:2010IEC 60601-2-10:2012FCC 47 CFR Part 15IEC 62304:2006ISO 14971:2007ANSI/AAMI ES60601-1:2005 / A2:2010 | IEC 60601-1-2:2007IEC 60601-1-11:2010IEC 60601-2-10:2012ISO 14971:2007 | IEC 60601-1-2:2007IEC 60601-1-6:2013IEC 60601-1-11:2010IEC 60601-2-10:2012IEC 62304:2006ISO 14971:2007 | Similar asEfit andCompexThecollateralstandardIEC 60601-1-11 is notapplied inWIEMSPROdevice |
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510(k) Premarket Notification
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510(k) Premarket Notification
Maximum output current value is higher in the WIEMSPRO device: 125 mA compared to 72 mA (E-fit) and 116 mA (Compex Wireless USA), however maximum output current density for the WIEMSpro device is of 1,92 mA/cm² much lower than that of Compex Wireless USA (3,84mA/cm²).
Also, upon analysis of the comparison of the different characteristics presented in the table above, none of the differences spotted impact the equivalence of the subject device when compared to the predicate devices.
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INTENDED USE:
As established in the Indications for Use Statement:
WIEMSPRO intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The WIEMSpro is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the WIEMSPRO training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated.
WIEMSPRO is a machine with electronic muscle stimulation based on EMS technology. Regarding its use, the device is specifically designed as an addition to other sports and for training muscles. It must be used for only healthy muscles and clients, not for rehabilitation purposes.
WIEMSPRO electrical impulses allow the triggering of action potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.
SUMMARY DISCUSSION OF NON-CLINICAL DATA:
The proposed device has been subject to bench testing to determine conformance to performance specifications and requirements taking account of its intended use as a wireless electro muscle stimulation device for fitness.
Functional laboratory testing performed in foreseeable operating conditions showed correct operation of the device as per its intended use, specifically including:
- Electrical safety (including particular requirements for the basic safety and essential performance of nerve and muscle stimulator and for medical electrical equipment)
- Electromagnetic compatibility -
- FCC Radio Frequency Testing The WiEMSpro device was tested to FCC requirements and found to comply with the requirements of 47 CFR Part 15 §15.107 and §15.109.
The new device is designed and manufactured in accordance with the following standards:
- IEC 60601-1-2:2007 ●
- IEC 60601-2-10:2012 ●
- IEC 60601-1-6 Edition 3.1 2013-10 ●
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- ISO 14971 Second Edition 2007-03-01 ●
- EN ISO 13485:2003 /AC2009 ●
- IEC 62304:2006 ●
- ANSI/AAMI ES60601-1: 2005 / A2:2010 ●
SUMMARY DISCUSSION OF CLINICAL DATA:
Non-clinical test data are submitted to support this premarket notification and to establish substantial equivalence. No clinical studies are submitted.
CONCLUSIONS:
We believe the intended use, the indications for use and principle of operation of WIEMSpRo are the same as the intended use, indications for use and performance of the predicate devices. We did not use any new technology in this system, so those differences between our new system and its predicate do not affect the safety and effectiveness (SE).
-
- General information of both devices is the same
-
- Intended use and indications/principle of operations of both devices are the same.
-
- There are minimum differences in the technological characteristic/performance data of the proposed device and those of the predicate devices, nevertheless, all of them comply with IEC 60601-1-2, IEC 60601-2-10. Thus the SE is not affected.
Based on the information provided in this premarket notification. Medical Cables, S.L. concludes that WIEMSER is substantially equivalent to the predicate devices with regard to safety and effectiveness.
§ 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).