Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA) include Vaginal Probe SA-2876, SA-25145, SA-20100, SA-3478, SA-2687 & Rectal Probe SA-1483, SA-19108, SA-1563, SA-2486 are intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of week pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.

Device Description

Well-Life Probe Electrodes for Stimulation/EMG Probes (Model: SA) contains two types of products, Vaginal Probe and Rectal Probe. The Well-Life Probe Electrode for Stimulation/EMG Probe are intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of week pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.

Well-Life Probe Electrode for Stimulation/EMG (Vaginal Probe) SA-2876, SA-25145, SA-20100, SA-3478, SA-2687 are lightweight cylinders consisting of two or three independent conductive rings or plates that are paired and isolated, physically, and electrically. The cylinder is shaped with a waist and handle for positioning in the vaginal canal for incontinence treatment and easy removal after treatment. It is watertight to allow for washing with soap and water between uses. The electrode is designed for repeated intermittent use by a single user in home or clinic up to 300 times, 15 minutes per session equal to 10 months of daily operation. It does not require sterilization, but does require washing before and after reuse according to the cleaning method as recommended in the user manual.

Well-Life Probe Electrode for Stimulation/EMG (Rectal Probe) SA-1483, SA-19108, SA-1563, SA-2486 are lightweight cylinders consisting of two or three independent conductive rings that are paired and isolated, physically, and electrically. The cylinder is shaped with a waist and handle for positioning in the rectal canal for incontinence treatment and easy removal after treatment. It is watertight to allow for washing with soap and water before and after uses. The electrode is designed for repeated intermittent use by a single user in home or clinic up to 300 times, 15 minutes per session equal to 10 months of daily operation. It does not require sterilization, but does require washing before and after reuse according to the cleaning method in user manual. The probe is constructed of stainless steel, acrylonitrile butadiene styrene (ABS), and polyvinyl chloride (PVC).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), based on the provided FDA 510(k) summary:

This device is an electrode probe and does not generate energy itself, but rather interfaces with an external electrical stimulator device. Therefore, the acceptance criteria and testing focus on the safety, material compatibility, and physical performance of the probe itself, and its equivalence to predicate devices that have established a safe and effective profile. The "device performance" in this context refers to its ability to meet these safety and functional specifications, rather than a diagnostic or therapeutic accuracy metric typical of AI-powered devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance
Biocompatibility	ISO 10993-1, ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization, irritation), ISO 10993-12 (sample preparation)	Device complies with these standards; tests performed for cytotoxicity, sensitization, and irritation.
Usability/Labeling (Home Use)	FDA guidance "Design Considerations for Devices Intended for Home Use," 21 CFR Part 801, 21 CFR Part 809.10	Labeling instructions compared to validated OTC reference device; additional usability testing deemed unnecessary due to similarity.
Reprocessing/Cleaning	FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling"	Instructions in labeling followed the guidance for reprocessing and cleaning.
Performance (Stimulation/EMG Function)	ANSI AAMI NS4:2013(R)2017 (Transcutaneous Electrical Nerve Stimulators)	Performance bench testing verified specifications. (Implicitly, the probe functions correctly to deliver/receive electrical signals within the specified parameters when connected to a compatible stimulator).
Shelf Life/Aging	ASTM F1980-16 (Accelerated Aging of Sterile Barrier Systems for Medical Devices)	Functional performance testing conducted on aged samples after accelerated aging to support a 2-year shelf life.
Electrical Safety (Patient Leads)	IEC 60601-1:2005, MOD, subclause 8.5.2.3 (Patient Leads of Patient Cables)	Testing performed to verify performance to specifications. (EMC and other electrical safety testing beyond patient leads was deemed unnecessary as the probe is a component, not an energy-generating device).
Mechanical Strength (Cable Connection)	ANSI AAMI EC53:2013/(R)2020 (ECG trunk cables and patient leadwires)	Tensile strength of cable connection test performed to ensure safety of electrical connection.
Material Composition	Constructed of stainless steel, acrylonitrile butadiene styrene (ABS), and polyvinyl chloride (PVC).	Stated material composition.
Functional Equivalence	To predicate device (K122194 LIFE-CARE VAGINAL PROBE, LIFE-CARE ANAL PROBE) and reference device (K191312 TensCare Ltd. Perfect PFE)	The subject device has many features and technological characteristics similar to the predicate, and performance testing supports that any differences do not impact safety and effectiveness.
Prescription/OTC Use	Instruction equivalence to K191212	Instructions are equivalent and include information for suitable stimulator selection, supporting both OTC and RX.

2. Sample Size Used for the Test Set and Data Provenance

The provided document describes non-clinical bench testing rather than human clinical studies with a "test set" in the traditional sense of AI data.

Test Set Sample Size: Not applicable in the context of clinical data for algorithmic performance. The "samples" refer to units of the manufactured device used for physical and material testing. The exact number of units tested for each benchmark is not specified but is implicitly sufficient to meet the requirements of the cited standards.
Data Provenance: Not applicable as this is bench testing of physical device components, not retrospective or prospective clinical data from human subjects. The testing was conducted by or on behalf of the manufacturer, Well-Life Healthcare Ltd., based in Taiwan.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The ground truth for this type of device (a probe electrode) is established by adherence to recognized national and international standards (e.g., ISO, ASTM, AAMI, IEC) for material safety, electrical performance, and mechanical integrity. There are no "experts" establishing a "ground truth" for diagnostic or clinical accuracy as this is a passive medical device component. The "experts" involved would be the engineers and technicians performing the tests and comparing the results to the predetermined pass/fail criteria of the standards.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human interpretation or clinical outcomes that would require an adjudication method like 2+1 or 3+1. Testing involves objective measurements against predefined engineering and biocompatibility standards.

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

Not applicable. This device is a passive probe electrode for stimulation and EMG, not an AI-powered diagnostic or therapeutic tool that would involve "human readers" or AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. There is no algorithm or AI component in this device. It is a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for this device's safety and performance is based on:

Established engineering standards: e.g., electrical safety parameters, mechanical strength thresholds.
Biocompatibility standards: ensuring materials are non-toxic, non-irritating, and non-sensitizing.
Predicate device characteristics: demonstrated safe and effective use of similar devices already on the market.

8. The Sample Size for the Training Set

Not applicable. There is no AI or machine learning component, therefore no training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no training set.

Summary

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December 29, 2022

Well-Life Healthcare Limited Jenny Hsieh Official Correspondent 6F., No. 168. de St., Jhonghe District New Taipei City, 235 Taiwan

Re: K222528

Trade/Device Name: Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA) Regulation Number: 21 CFR§ 876.5320 Regulation Name: Nonimplanted Electrical Continence Device Regulatory Class: II Product Code: KPI, HIR Dated: November 17, 2022 Received: November 30, 2022

Dear Jenny Hsieh:

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.

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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/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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,

Jessica K. Nguyen -S

Jessica K. Nguyen, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K222528

Device Name

Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA)

Indications for Use (Describe)

Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA) include

Vaginal Probe SA-2876, SA-25145, SA-20100, SA-3478, SA-2687 & Rectal Probe SA-1483,

SA-19108, SA-1563, SA-2486 are intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of week pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Type of Submission:	Traditional
Preparation date:	12/28/2022
Submitter:	Well-Life Healthcare Ltd.
Address:	6F. No.168, Lide St., Jhonghe District, New TaipeiCity, 23512, Taiwan
Phone:	+886-2-22266981
Fax:	+886-2-22266965
Contact:	Jenny Hsieh(Jenny@welllifehealthcare.com.tw)
Registration number:	3006850006

4. Identification of the device:

510(K) No	K222528
Device Name:	Well-Life Probe Electrode for Stimulation/EMGProbe (Model: SA)
Common or usual name:	Incontinence Stimulation/EMG ElectrodeProbe
Model:	Vaginal Probe:SA-2876, SA-25145, SA-20100, SA-3478, SA-2687Rectal Probe:SA-1483, SA-19108, SA-1563, SA- 2486
Classification name:	Nonimplanted Electrical Continence Device
Classification Panel:	Gastroenterology-Urology
Device Classification:	II
Regulation Number:	21 CFR Part 876.5320
Product Code	KPI & HIR

5. Identification of the Predicate and Reference Devices:

Predicate Device:
510(K) No	K122194
Predicate Device Name:	LIFE-CARE VAGINAL PROBE, LIFE-CAREANAL PROBE. The predicate has not been subjectto a design-related recall.
Model:	Everyway Incontinence Stimulation Electrode,model PR-02/02A, PR-03/03/A, PR-04/04A, PR-10A, PR-11A, PR-14A, for Life-Care VaginalProbe & PR-06/06A, PR-12A, PR-13/13A for Life-Care Anal Probe.

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Classification name:	Nonimplanted Electrical Continence Device
Classification Panel:	Gastroenterology-Urology
Device Classification:	II
Regulation Number:	21 CFR Part 876.5320
Product Code	KPI & HIR

Reference Device:
510(K) No	K191312
Reference Device Name:	TensCare Ltd. Perfect PFE
Model:	Vaginal Probe:Liberty Loop Vaginal Probe (X-VPL)Electrical Stimulator:Perfect PFE
Classification name:	Nonimplanted Electrical Continence Device
Classification Panel:	Gastroenterology-Urology
Device Classification:	II
Regulation Number:	21 CFR Part 876.5320
Product Code	KPI

6. Intended Use and Indications for use of the Subject Device:

Intended Use

Electrical stimulation of the pelvic floor muscles for the treatment of urinary incontinence. Electromyographic (EMG) sensing of the pelvic floor muscles.

Indications for use

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7. Description of the Device:

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Elements ofComparison	Subject Device	Predicate Device	Reference Device	Remark
510K number	K222528	K122194	K191312	------
Device Name	Well-Life ProbeElectrode forStimulation/EMGProbe Model: SAVaginal Probe:SA-2876, SA-25145,SA-20100, SA-3478, SA-2687Rectal Probe (RectalProbe):SA-1483, SA-19108, SA-1563,SA-2486	Vaginal Probe:PR-02/ PR-02A, PR-03/PR-03A, PR-04/ PR-04A.PR-10A, PR-11A, PR-14AAnal Probe:PR-06/06A, PR-12A,PR-13/13A	Vaginal Probe:Liberty Loop VaginalProbe (X-VPL)Electrical Stimulator:Perfect PFE
Product Code	KPI & HIR	KPI & HIR	KPI	Same as Predicate
Prescriptive orOver-the-Counter (OTC)	OTC and RX	RX	OTC and RX	Instructions areequivalent toK191212 andinclude informationfor suitablestimulatorselection
Regulation No	21 CFR Part 876.5320	21 CFR Part 876.5320	21 CFR Part 876.5320	Same as Predicate
Indicationsfor Use	Well-Life ProbeElectrode forStimulation/EMG Probe(Model: SA) includeVaginal Probe SA-2876,SA-25145, SA-20100,SA-3478, SA-2687 &Rectal Probe SA-1483,SA-19108, SA-1563,SA-2486 are intended toprovideelectromyographicfeedback from pelvicmusculature or electricalstimulation to pelvicmusculature for thepurpose of rehabilitationof week pelvic floormuscles and restorationof neuromuscularcontrol during thetreatment of urinaryincontinence.	The everywayincontinence stimulationelectrode, model pr-02/02a, pr-03/03a, pr-04/04a, pr-10a, pr-11a, pr-14a for life-care vaginalprobe & pr-06/06a, pr-12a, pr-13/13a for life-care anal probe areintended to provideelectromyographicfeedback from pelvicmusculature or electricalstimulation to pelvicmusculature for thepurpose of rehabilitationof weak pelvic floormuscles and restoration ofneuromuscular controlduring the treatment ofurinary incontinence.	Perfect PFE is intendedto provide electricalstimulation andneuromuscular re-education for the purposeof rehabilitation of weakpelvic floor muscles forthe treatment of stress,urge and mixed urinaryincontinence in womenand to maintain urinarycontinence in women.	Same as Predicate
Intended Use	Electrical stimulation ofthe pelvic floor musclesfor the treatment ofurinary incontinence.EMG sensing of thepelvic floormuscles.	Electrical stimulation ofthe pelvic floor musclesfor the treatment ofurinary incontinence.EMG sensing of thepelvic floor muscles.	Perfect PFE is intendedto provide electricalstimulation andneuromuscularreeducation for thepurpose of rehabilitationof weak pelvic floormuscles for the treatmentof stress, urge and mixedurinary incontinence inwomen and to maintainurinary continence inwomen.	Same as Predicate
ContactDuration	Intermittent mucosalcontact<30 min/ session-Stim<1 hour/session-EMG not exceeding 1hrcombined	Intermittent mucosalcontact<30 min/ session-Stim<1 hour/session-EMG not exceeding 1hrcombined	Unknown	Same as Predicate
Product Type	Probe only	Probe only	Probe + ElectricalStimulator	Same as Predicate
ElectrodePlacement	VaginalRectal(Anal)	VaginalAnal	Vaginal	Same as Predicate
UsageConditions	Reusable-Single Patient	Reusable-Single Patient	Reusable-Single Patient	Same
ElectrodeMaterial	Stainless steel	Stainless steel	Stainless Steel	Same
Frequency(Hz)	No energy transmissionHowever, thespecifications of thematched Electricalstimulator must besmaller than 50Hz	No energy transmission	Max: 50Hz	Equivalent toPredicate
Pulse Width	No energy transmissionHowever, thespecifications of thematched Electricalstimulator must besmaller than 300 us	No energy transmission	Max: 300us	Equivalent toPredicate
MaximumOutputVoltage (V)	No energy transmissionHowever, thespecifications of thematched Electricalstimulator must besmaller than 45V 500Ω	No energy transmission	45V @500Ω	Equivalent toPredicate
MaximumOutputCurrent (A)	No energy transmissionHowever, thespecifications of thematched Electricalstimulator must besmaller than 90mA@500Ω	No energy transmission	90mA @500Ω	Equivalent toPredicate
Max R.M.SPowerDensity (W-r.m.s/cm²)	No energy transmissionHowever, thespecifications of thematched Electricalstimulator must besmaller than 0.25 W/cm²@500Ω	No energy transmission	0.014 W /cm² @500Ω	Equivalent toPredicate
Max R.M.SCurrentDensity (mA-r.m.s/cm²)	No energy transmissionHowever, thespecifications of thematched Electricalstimulator must besmaller than 2 mA /cm²@500Ω	No energy transmission	0.318 mA/cm² @500Ω	Equivalent toPredicate
ElectrodeArea (Single-Electrode)	VaginalSA-2876: 7.62 cm²SA-25145: 7.87 cm²SA-20100: 6.25 cm²SA-3478: 4.25 cm²SA-2687: 6.12 cm²RectalSA-1483: 1.93 cm²SA-19108: 3.77 cm²SA-1563: 2.17 cm²SA-2486 2.85 cm²	VaginalPR-02A: 7.65 cm²PR-03A: 7.87 cm²PR-04A: 6.25 cm²PR-10A: 6.25 cm²PR-11A: 6.25 cm²PR-14A: 6.00 cm²AnalPR-06A: 1.93 cm²PR-12A: 2.26 cm²PR-13A: 3.77 cm²	Liberty Loop VaginalProbe (X-VPL): 4.24cm²	Similar/Equivalent

8. Comparison of Technological Characteristics

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9. Statement of conformity

List of FDA-recognized voluntary consensus standards cited in this submission.

RecognitionNumber	Standard DesignationNumber and Date	Title Of Standard	Date OfRecognition
2-258	ISO 10993-1Fifth Edition 2018-08	Biological evaluation of medical devices -Part 1: Evaluation and testing within a riskmanagement process	01/14/2019
2-245	ISO 10993-5Third Edition 2009-06-01	Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity	02/23/2016
2-296	ISO 10993-10 Fourthedition 2021-11	Biological evaluation of medical devices -Part 10: Tests for skin sensitization	05/30/2022
2-291	ISO 10993-23 Firstedition 2021-01	Biological evaluation of medical devices- Part 23: Tests for irritation	06/07/2021
17-14	ANSI AAMINS4:2013(R)2017	Transcutaneous Electrical NerveStimulators 2013(R)2017	01/14/2019
14-497	ASTM F1980-16	Standard Guide for Accelerated Aging ofSterile Barrier Systems for MedicalDevices	12/23/2016
5-114	IEC 62366-1Edition 1.0 2015-02	Medical devices - Part 1: Application ofusability engineering to medical devices	12/23/2016
19-4	IEC 60601-1:2005,MOD	Medical electrical equipment- Part 1:General requirements for basic safety andessential performance	07/09/2014
3-129	ANSI AAMIEC53:2013/(R)2020	ECG trunk cables and patient leadwires	06/07/2021

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10. Non-Clinical Testing Summary:

Non-clinical testing was conducted to verify that the subject devices met all design specifications, demonstrated safety based on current industry standards, and to demonstrate substantial equivalence to the predicate. The following tests were performed:

1. Biocompatibility Patient contacting components are in compliance with ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, including cytotoxicity (ISO 10993-5 Third Edition 2009-06-01), sensitization (ISO 10993-10 Fourth edition 2021-11), irritation (ISO 10993-10 Fourth edition 2021-11) and Sample preparation and reference materials (ISO 10993-12 Fourth Edition 2012-07-01).
1. Recommendations and requirements outlined in the FDA guidance "Design Considerations for Devices Intended for Home Use," 21 CFR Part 801, and 21 CFR Part 809.10 were followed. A comparison to the instructions of the reference device which have been validated for OTC use were conducted to support OTC instructions in the labeling. Based on the similarity of the Well-Life Probe Electrode to the predicate and reference devices with respect to design, indications for use, cleaning instructions, and labeling materials, additional usability testing was determined not to be necessary.
1. Recommendations and requirements outlined in the FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" were followed for reprocessing and cleaning instructions in the labeling.
1. Performance Bench Testing was performed to verify the performance to specifications of the proposed device and included the following:
- Performance Bench testing was performed to verify the performance to specifications with ANSI AAMI NS4:2013(R)2017.
- ASTM F1980-16 "Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices" was followed for accelerated aging of the subject device. After accelerated aging, functional performance testing was conducted on aged samples to support the proposed shelf life of 2 years.
- Testing was performed to verify the performance to specifications of the proposed device to subclause 8.5.2.3, Patient Leads of Patient Cables of IEC 60601-1:2005, MOD to comply with 21 CFR 898. Electromagnetic Compatibility (EMC) and Electrical Safety Testing beyond subclause 8.5.2.3, Patient Leads of Patient Cables of IEC 60601-1:2005, MOD was not determined to be necessary because the subject device is an individual component of an electrical system that does not generate or control electrical power, similar to the predicate device.
- Performance Testing Bench- Tensile strength of cable connection test per ANSI AAMI EC53:2013/(R)2020 related test methods for lead wire strength of cable connection test to ensure the safety of related electrical connection of products.

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11. Conclusion:

After comparison and evaluation, the subject device "Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA)" has many of the features and technological characteristics of the predicate device, and performance testing supports that any differences do not impact safety and effectiveness of the subject device. Thus, the subject device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 876.5320 Nonimplanted electrical continence device.

(a)
Identification. A nonimplanted electrical continence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical cable to a battery-powered pulse source. The plug or pessary is inserted into the rectum or into the vagina and used to stimulate the muscles of the pelvic floor to maintain urinary or fecal continence. When necessary, the plug or pessary may be removed by the user. This device excludes an AC-powered nonimplanted electrical continence device and the powered vaginal muscle stimulator for therapeutic use (§ 884.5940).(b)
Classification. Class II (performance standards).