(89 days)
The Facial Toning device is intended to stimulate the face. The device is intended for cosmetic use.
The Facial Toning devices, which come in two models (UIC-189, UIC-589), are intended for facial stimulation and are indicated for prescription cosmetic use. The anatomical site for application of the devices are the face.
UIC-189 is battery powered, has 4 output channels and has 4 operation programs.
UIC-589 is AC powered, has 10 output channels and has 4 operation programs.
The device is equipped with accessories of self-adhesive pads (cleared under K160081), electrode probes, electrode cables and adapters. All accessories, including self-adhesive pads, electrode probes, electrode cables and adapters can only be changed or replaced by a qualified person.
This FDA 510(k) summary does not contain information about the performance of an AI/ML device. Instead, it describes a "Facial Toning device" which is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief, specifically for cosmetic use involving facial stimulation.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and reported device performance for an AI/ML device.
- Sample size used for the test set and data provenance (e.g., country of origin of the data, retrospective or prospective) for an AI/ML device.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI versus without AI assistance.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML device.
- The sample size for the training set of an AI/ML device.
- How the ground truth for the training set was established for an AI/ML device.
The document primarily focuses on demonstrating substantial equivalence to predicate devices (K181062 and K130065) through a comparison of technical specifications and compliance with electrical safety and biocompatibility standards for the TENS device.
Information available regarding the Facial Toning Device:
Acceptance Criteria and Reported Device Performance (Summary from Non-clinical Testing section):
The device "met all requirements" based on bench tests. The compliance standards serve as the acceptance criteria for various aspects of the device's safety and performance:
| Acceptance Criteria (Standards Complied With) | Reported Device Performance (Implied by Compliance) |
|---|---|
| Electrical Safety & Essential Performance: | Device meets general requirements for basic safety and essential performance of medical electrical equipment. |
| AAM/ANSI ES 60601-1:2005 & A1:2012, C1:2009(R)2012 & A2:200(R)2012 (Cons. Text) [Incl. AMD2:2021] (IEC 60601-1:2005, MOD) | |
| Electromagnetic Compatibility: | Device meets requirements for electromagnetic disturbances. |
| IEC 60601-1-2 Edition 4.1 2021-09 CONSOLIDATED VERSION | |
| Nerve & Muscle Stimulator Specific Safety: | Device meets particular requirements for basic safety and essential performance of nerve and muscle stimulators. |
| IEC 60601-2-10 Edition 2.1 2016-04 | |
| Biocompatibility - Cytotoxicity: | Device components meet requirements for in vitro cytocompatibility. |
| ISO 10993-5 Third Edition 2009-06-01 | |
| Biocompatibility - Skin Sensitization: | Device components meet requirements for skin sensitization. |
| ISO 10993-10 Fourth edition 2021-11 | |
| Biocompatibility - Irritation: | Device components meet requirements for irritation. |
| ISO 10993-23 First edition 2021-01 | |
| Battery Safety (for UIC-189 model): | If applicable (for battery-powered models), device's lithium systems (batteries) meet safety requirements for portable secondary cells and batteries made from them. |
| IEC 62133-2 Edition1.0 2017-02 |
Study Proving Device Meets Acceptance Criteria:
The study that proves the device meets the acceptance criteria is a "Non-clinical Testing Summary" which involved bench tests.
The document indicates these bench tests verified that the proposed device met all requirements as outlined by the listed international standards. No details on sample size for these bench tests, data provenance (beyond the fact they were "bench tests"), or expert involvement are provided. There is no mention of an AI component or associated studies like MRMC or standalone performance evaluations for an algorithm.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 12, 2024
Body Trim Industrial Co., Ltd % Bell Bai Regulatory Affairs Project Manager Shenzhen Huatongwei International Inspection Co., Ltd. Building 7, Baiwang Idea Factory, No.1051, Songbai Road Yangguang Community, Xili Subdistrict, Nanshan District Shenzhen, Guangdong China
Re: K233667
Trade/Device Name: Facial Toning device (UIC-189); Facial Toning device (UIC-589) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NFO Dated: November 7, 2023 Received: November 15, 2023
Dear Bell Bai:
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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products: and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 L. Dean -S
Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation
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and Rehabilitation 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) K233667
Device Name
Facial Toning device (UIC-189); Facial Toning device (UIC-589)
Indications for Use (Describe)
The Facial Toning device is intended to stimulate the face. The device is intended for cosmetic use.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
[As required by 21 CFR 807.92]
| 1. Submission Information510(k) Number: | K233667 |
|---|---|
| Date: | November 7th, 2023 |
| Type of 510(k) Submission: | Traditional 510(k) |
| Basis for 510(k) Submission: | New device |
| Submitter/Manufacturer: | BODY TRIM INDUSTRIAL CO., LTD6F., No. 178, Huanhe Rd., Xindian Dist., New Taipei City 231034,Taiwan (R.O.C.)Tel: +886-2-22188906E-mail: bodytrimtw@gmail.com |
| Contactor: | Bell BaiShenzhen Huatongwei International Inspection Co.,Ltd.Building 7, Baiwang Idea Factory, No.1051, Songbai Road, YangguangCommunity, Xili Subdistrict, Nanshan District, Shenzhen, Guangdong,ChinaE-mail: service@regtalink.comTel: +86-0755-86325730 |
| 2. Device Description | |
| Proprietary Name: | Facial Toning device |
| Model Name: | UIC-189, UIC-589 |
| Classification Name: | Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
| Product Code: | NFO |
| Device Class: | 2 |
| Regulation Number: | 21 CFR 882.5890 |
| Review Panel: | Neurology |
| Indications for use: | The Facial Toning device is intended to stimulate the face. The device isintended for cosmetic use. |
| Device Description: | The Facial Toning devices, which come in two models (UIC-189,UIC-589), are intended for facial stimulation and are indicated forprescription cosmetic use. The anatomical site for application of thedevices are the face. |
| UIC-189 is battery powered, has 4 output channels and has 4 operationprograms. | |
| UIC-589 is AC powered, has 10 output channels and has 4 operationprograms. | |
| The device is equipped with accessories of self-adhesive pads (clearedunder K160081), electrode probes, electrode cables and adapters. Allaccessories, including self-adhesive pads, electrode probes, electrodecables and adapters can only be changed or replaced by a qualified person. |
3. Predicate Device Identification
| 510(k) Number: | K181062 | K130065 |
|---|---|---|
| Product Name: | Ultra Facial Toning System | Beautiful Image Model 900 Facial Toning Device |
| Submitter: | Micro Current Technology, Inc. | Biosonic Technologies, LLC. |
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4. Substantially Equivalent Comparison
Table 1-
| Parameters | New Device | Predicate Device 1 | Predicate Device 2 | Remark | |
|---|---|---|---|---|---|
| 510(k) Number: | K233667 | K181062 | K130065 | -- | |
| Marketing clearance date: | -- | July 18, 2018 | April 30, 2014 | -- | |
| Device Name | Facial Toning device | Ultra Facial Toning System | Beautiful Image Model 900 FacialToning Device | -- | |
| Model | UIC-189 | / | Model 900 | -- | |
| 510(k) Owner | BODY TRIM INDUSTRIAL CO.,LTD | Micro Current Technology, Inc. | Biosonic Technologies, LLC. | -- | |
| Intended use | The Facial Toning device is intendedto stimulate the face. The device isintended for cosmetic use. | The Ultra Facial Toning System isintended to stimulate the face. Thedevice is intended for cosmetic use. | The Beautiful Image Model 900 FacialToning Device uses microcurrentelectrical energy to stimulate facialtissues for aestheticpurposes. | Same | |
| Type of use | Prescription Use | Prescription Use | Prescription Use | Same | |
| Power Source(s) | 3.7V 5200mAh Rechargeable lithiumbattery | 9V alkaline battery | One 6V battery | Similar | |
| - Method of Line Current Isolation | Type BF | Type BF | N/A | Same | |
| - Patient Leakage Current | -- | -- | -- | Same | |
| - Normal Condition (μA) | < 10μA | < 10μA | N/A | Same | |
| - Single Fault Condition (µA) | < 50μA | < 50μA | N/A | Same | |
| Average DC current throughelectrodes when device is on but nopulses are being applied (µA) | < 0.01 μA | < 0.01μA | None | Same | |
| Number of Output Modes | 4 | 2 | 1 | Similar | |
| Number of Output channels: | 4 | 2 | 1 | Same | |
| - Synchronous or Alternating? | Synchronous | Unpublished | N/A | Similar | |
| - Method of Channel Isolation | Current transformr Isolation | Unpublished | N/A | Same | |
| Regulated Current or RegulatedVoltage? | Current control | Unpublished | Both | Same | |
| Software/Firmware/MicroprocessorControl? | Yes | Yes | Yes | Same | |
| Automatic Overload Trip? | No | No | Yes | Same | |
| Automatic No-Load Trip? | No | No | Yes | Same | |
| Automatic Shut Off? | Yes | Yes | Yes | Same | |
| Patient Override Control? | Yes | Yes | Yes | Same | |
| Indicator | On/Off Status? | Yes | Yes | Yes | Same |
| Display: | Low Battery? | Yes | Yes | Yes | Same |
| Voltage/CurrentLevel? | Yes | Yes | Yes | Same | |
| Timer Range (minutes) | 1~ 60 minutes, 1min/step | 12 or 15 minutes | None | Same | |
| CompliancewithStandards? | Voluntary | AAMI/ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-2-10 | IEC 60601-1, IEC 60601-1-2, IEC60601-2-10 | IEC 60601-1 | Same |
| Compliance with 21 CFR 898? | Yes | Yes | Yes | Same | |
| Weight (grams) | Approx. 700g | Unpublished | 10lbs | Similar | |
| Dimensions [W x H x D] | 220 mm202mm143mm | Unpublished | 5.515.311.3(in.) | ||
| Housing Materials & Construction | ABS | Unpublished | Thermoplastic | Same | |
| Waveform | Pulsed, monophasic | Pulsed, monophasic | biphasic | Same | |
| Shape | Rectangular, trapezoidal, withinterphase interval | Rectangular | Rectangular | Same | |
| Maximum Output Voltage (volts) | $160mV\pm10% @500\Omega$ | $30.8V @500\Omega$ | $0.347V\pm5% @500\Omega$ | Similar | |
| Maximum Output Current (specifyunits) | $0.32mA\pm10% @500\Omega$ | $61.6mA @500\Omega$ | $0.647mA\pm5% @500\Omega$ | ||
| Pulse width (usec) | $2.5-2500mS\pm10%$ | 1-10000mS | 3.24-1610mS | ||
| Max. pulse frequency (Hz) [or Rate(pps)] | $0.3-200Hz\pm10%$ | 0.1-300Hz | 0.621-308.6Hz | ||
| Net Charge (μC per pulse) | $150\muC @500\Omega$ | Unpublished | $0\muC @500\Omega$ | Similar | |
| Maximum Phase Charge | $200\muC@500\Omega$ | Unpublished | $190\muC @,500\Omega$ | ||
| Maximum Average Current | $0.16mA@500\Omega$ | Unpublished | $0.493mA@500\Omega$ | ||
| Maximum Current Density | $0.08mA/cm^2 @500\Omega$ | Unpublished | $1.486mA/cm^2 @500\Omega$ | ||
| Maximum Average Power Density | $12.7\muW/cm^2@500\Omega$ | Unpublished | $366E-6W/cm^2@500\Omega$ | ||
| Accessories | Electrode probes, Self-adhesive pads(K160081), Electrode cables | Electrode probes, DIN plug, Cotton buds | Electrode probes, Electrode cables | Same | |
| Biocompatibility | Compliance with ISO 10993-1 | Compliance with ISO 10993-1 | Compliance with ISO 10993-1 | Same |
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Table 2-
| Parameters | New Device | Predicate Device 1 | Predicate Device 2 | Remark | |
|---|---|---|---|---|---|
| 510(k) Number | K233667 | K181062 | K130065 | -- | |
| Device Name | Facial Toning device | Ultra Facial Toning System | Beautiful Image Model 900 Facial Toning | -- | |
| Device | |||||
| Model | UIC-589 | / | Model 900 | -- | |
| 510(k) Owner | BODY TRIM INDUSTRIAL CO., LTD | Micro Current Technology, Inc. | Biosonic Technologies, LLC. | -- | |
| Intended use | The Facial Toning device is intended tostimulate the face. The device is intendedfor cosmetic use. | The Ultra Facial Toning System isintended to stimulate the face. The deviceis intended for cosmetic use. | The Beautiful Image Model 900 FacialToning Device uses microcurrentelectrical energy to stimulate facial tissuesfor aestheticpurposes. | Same | |
| Type of use | Prescription Use | Prescription Use | Prescription Use | Same | |
| Power Source(s) | 100-240 VAC, 50-60 Hz | 9V alkaline battery | One 6V battery | Similar | |
| - Method of Line CurrentIsolation | Type BF | Type BF | N/A | Same | |
| - Patient Leakage Current | -- | -- | Same | ||
| - Normal Condition (μΑ) | < 10μΑ | < 10μA | N/A | ||
| - Single Fault Condition(μΑ) | < 50μA | < 50μA | N/A | ||
| Average DC current throughelectrodes when device is onbut no pulses are being applied(μΑ) | < 0.01μΑ | < 0.01μA | None | Same | |
| Number of Output Modes | 4 | 2 | 1 | Similar | |
| Number of Output channels: | 10 | 2 | 1 | Same | |
| - Synchronous orAlternating? | Synchronous | Unpublished | N/A | Similar | |
| - Method of ChannelIsolation | Current transformer Isolation | Unpublished | N/A | Same | |
| Regulated Current or RegulatedVoltage? | Current control | Unpublished | Both | Same | |
| Software/Firmware/Microprocessor Control? | Yes | Yes | Yes | Same | |
| Automatic Overload Trip? | No | No | Yes | Same | |
| Automatic No-Load Trip? | No | No | Yes | Same | |
| Automatic Shut Off? | Yes | Yes | Yes | Same | |
| User Override Control? | Yes | Yes | Yes | Same | |
| Indicator | Yes | Yes | Yes | Same | |
| Display | Status | ||||
| Low Battery | Yes | Yes | Yes | Same | |
| Voltage/Current Level | Yes | Yes | Yes | Same | |
| Timer Range (minutes) | 1~ 60 minutes, 1min/step | 12 or 15 minutes | None | Same | |
| Compliance with Voluntary Standards? | AAMI/ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-2-10 | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10 | IEC 60601-1 | Same | |
| Compliance with 21 CFR 898? | Yes | Yes | Yes | Same | |
| Weight (grams) | 2kg | Unpublished | 10lbs | Similar | |
| Dimensions (mm) [W x H x D] | 36025550mm | Unpublished | 5.515.311.3(in.) | Similar | |
| Housing Materials & Construction | Panel :PMMAMiddle Frame :ABSBottom Case: Iron | Unpublished | Thermoplastic | Similar | |
| Waveform | Pulsed, monophasic | Pulsed, monophasic | biphasic | Same | |
| Shape | Rectangular, trapezoidal, with interphase interval | Rectangular | Rectangular | Same | |
| Maximum Output Voltage (volts) | $160mV\pm10% @500\Omega$ | $30.8V @500\Omega$ | $0.347V\pm5% @500\Omega$ | Similar | |
| Maximum Output Current (specify units) | $0.32mA\pm10% @500\Omega$ | $61.6mA @500\Omega$ | $0.647mA\pm5% @500\Omega$ | ||
| Pulse width (usec) | 2.5-2500mS±10% | 1-10000mS | 3.24-1610mS | ||
| Max. pulse frequency (Hz) [or Rate (pps)] | 0.3-200Hz±10% | 0.1-300Hz | 0.621-308.6Hz | ||
| Net Charge (µC per pulse) | $150\mu C @500\Omega$ | Unpublished | $0\mu C @500\Omega$ | Similar | |
| Maximum Phase Charge, (µC) | $200\mu C@500\Omega$ | Unpublished | $190\mu C @500\Omega$ | Similar | |
| Maximum Average Current, (mA) | $0.16mA@500\Omega$ | Unpublished | $0.493mA@500\Omega$ | Similar | |
| Maximum Current Density, (mA/cm², r.m.s.) | $0.08mA/cm^2 @500\Omega$ | Unpublished | $0.1.486mA/cm^2 @500\Omega$ | ||
| Maximum Average Power Density | $12.7\mu W/cm^2@500\Omega$ | Unpublished | $366E-6W/cm^2@500\Omega$ | ||
| Accessories | Electrode probes, Self-adhesive pads (K160081), Electrode cables | Electrode probes, DIN plug, Cotton buds | Electrode probes, Electrode cables | Same | |
| Biocompatibility | Compliance with ISO 10993-1 | Compliance with ISO 10993-1 | Compliance with ISO 10993-1 | Same |
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The proposed device has similar indication for use as well as comparable technical and biocompatibility properties and characterisin, and the minor differences don't raise any additional questions on effectiveness. Therefore, the proposed device is substantially equivalent o the predicate device.
5. Non-clinical Testing Summary
Bench tests were conducted to verify that the proposed device met all requirements. The test results with the following stadards. - AAM / ANSES60601-1:2005 & A1:2012, C1:2009(R)2012 & A2:20 0(R)2012 (Cons. Text) [Incl. AMD2:2021], Medial electrical equipment - Part 1: Geneal requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)]
-IEC 60601-1-2 Edition 4.1 2021-09 CONSOLIDATED VERSION, Medical electrical equirements for basic sately and essential performance -Collateral Standard: Electromagnetic disturbances - Requirements and tests
-
IEC 60601-2-10 Edition 2.1 2016-04. Medical Equipments - Part 2-10. Paricular Requirements For The Basic Safety And Essential Performance Of Nerve And Muscle Stimulators.
-
ISO 10993-5 Third Edition 2009-06-01, Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytocompatibility)
-
ISO 10993-10 Fourth edition 2021-11, Biological evaluation of medical devices - Part 10: Tests for skin sensitization,
-
ISO 10993-23 First edition 2021-01, Biological evaluation of medical devices - Part 23: Tests for irritation.
-
IEC 62133-2 Edition1.0 2017-02, Secondary collaims alkaline or other non-acid electrolytes - Safety requirements for portable secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
6. Conclusion
The conclusion the nondinical tests denonstates that the subject device in 510(k) submission is as affective, as the legally maked predicate device K181062, K130065.
§ 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).