(44 days)
No
The document describes a device with LED light, hot compress, vibration, and micro-current stimulation functions. There is no mention of AI or ML in the device description, intended use, or performance studies. The software documentation is described as "Basic Documentation Level of concern," which is typically not associated with complex AI/ML algorithms.
Yes.
The device is intended for the treatment of facial wrinkles and mild to moderate inflammatory acne, which are therapeutic claims. It also references being cleared under K241718, which is a medical device clearance.
No
The device is intended for treatment of facial wrinkles and acne, and for aesthetic use, not for diagnosing medical conditions.
No
The device description explicitly states it is a "handheld portable device" consisting of a "main unit," "charging cable," "massage heads," and other physical components. It also describes hardware functions like LED irradiation, hot compress, vibration, and micro-current stimulation. While it mentions software verification and validation, this is in the context of controlling the hardware functions, not as a standalone software device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a "Micro-current Facial Beauty Device" intended for the treatment of facial wrinkles and acne through methods like LED light therapy, hot compress, vibration, and micro-current stimulation. These are all external treatments applied to the skin.
- No Sample Analysis: There is no mention of the device collecting or analyzing any biological samples from the user.
Therefore, based on the provided information, this device does not fit the definition of an In Vitro Diagnostic. It is an external aesthetic and therapeutic device.
N/A
Intended Use / Indications for Use
Micro-current Facial Beauty Device is intended for the treatment of facial wrinkles, and mild to moderate inflammatory acne. (cleared under K241718)
Micro-current Facial Beauty Device is a handheld portable device for over the counter aesthetic use including facial and neck stimulation.
Product codes
NFO
Device Description
The Micro-current Facial Beauty Device is a portable, non-sterile, reusable device designed to achieve the aesthetic effect. It consists of main unit, charging cable, cleaning flannelette, storage bag, instrument base and user manual. The device is supplied by internal rechargeable lithium battery, which can be recharged by external charger through the Type-C charging cable. The device is un-usable when charging. The device is only home environment use, which has two massage heads, and three LED light mode (Amber/ Red/ Blue lights are output independently) to provides following functions:
a. Amber, Red and Blue LED irradiation function. The device outputs amber light with the wavelength of 605±10nm, and red light with the wavelength of 630±10mm. It is used to illuminate facial skin with narrow spectral bandwidth light and treat facial wrinkles. Also, it outputs blue light with the wavelength of 415±10nm and is used to illuminate facial skin with narrow spectral bandwidth light and treat mild to moderate inflammatory acne. (Cleared under K241718)
b. Hot compress and vibration function. The device generates different intensity of vibration by a builtin motor to relax the facial skin, and also, the massage head is heated to 40±1℃, making the facial skin feel warm to relax and soothe the facial skin. (The vibration is classified as class I and not need for 510K, and the hot compress is not for medical purpose). (Cleared under K241718)
c. MS-Micro current stimulation function. The device has two electrode massage heads to do facial stimulation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Face and neck
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home environment use / Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance data were provided in support of the substantial equivalence determination.
- Biocompatibility Testing: The biocompatibility evaluation for the body-contacting components of the Micro-current Facial Beauty Device was conducted in accordance with the "Use of International Standard ISO 10993-1. 'Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process, Document Issued on September 4, 2020", as recognized by FDA. The following testing was performed to, and passed, including:
- ISO 10993-5: 2009, Biological evaluation of medical devices -Par t 5: Tests for in vitro cytotoxicity
- ISO 10993-10: 2021, Biological evaluation of medical devices Part 10: Tests for skin sensitization
- ISO 10993-23: 2021, Biological evaluation of medical devices Part 23: Tests for irritation
- Electrical Safety:
- IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
- IEC 60601-1-11 Medical Electrical Equipment -Part 1-11: General Requirements for Basic Safety and Essential Performance -Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
- IEC 60601-2-10 Medical electrical equipment Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
- IEC 62133-2, Secondary cells and batteries containing alkaline or other non-acid electrolytes -Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
- Software Verification and Validation: Software documentation consistent with Basic Documentation Level of concern was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
December 19, 2024
Shenzhen Aozemei Technology Co. Ltd Riley Chen RA Specialist Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90 Qianhai Road Shenzhen, Guangdong 518052 China
Re: K243430
Trade/Device Name: Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NFO Dated: November 5, 2024 Received: November 5, 2024
Dear Riley Chen:
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 (OS) 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 medical devices and radiation-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-regulatory
2
assistance/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 and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)
Indications for Use (Describe)
Micro-current Facial Beauty Device is intended for the treatment of facial wrinkles, and mild to moderate inflammatory acne. (cleared under K241718)
Micro-current Facial Beauty Device is a handheld portable device for over the counter aesthetic use including facial and neck stimulation.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary
"510(k) Summary" as required by 21 CFR Part 807.92.
I. Submitter
Company name: Shenzhen Aozemei Technology Co., LTD Address: 3/F, Building 9, Tianfu'an Industrial Park, lezhujiao, Huangmabu Community, Hangcheng Street, Baoan District, Shenzhen, Guangdong, China
Contact person: Zemin Wu Title: General Manager Tel.: +86-150 1922 0323 Email: 80728261@gq.com Date: 2024.11.5
II. Subject Device
Name of Device: Micro-current Facial Beauty Device Model(s): AM-810W, AM-810B, AM-812W, AM-812B Common or Usual Name: Stimulator, Transcutaneous Electrical, Aesthetic Purposes Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: NFO Regulation Number: 21 CFR 882.5890
III. Predicate Device
| No. | Manufacturer | Device name | Product code | 510(k) Number | Cleared Date |
|---|---|---|---|---|---|
| 1. | Heat In A Click | 2 Face / Face Evolution | NFO, OHS, OLP | K171821 | April 26, 2018 |
| 2. | Li-Tek Electronics | ||||
| Technology Co., Ltd. | Micro-current | ||||
| vibration | |||||
| facial cold and hot service | |||||
| Model: TPML-100 | NFO, OLP | K213039 | May 25, 2022 | ||
| 3. | BELEGA Co., Ltd. | BEAGANK 4T PLUS | NFO | K233010 | Nov. 21, 2023 |
IV. Device Description
The Micro-current Facial Beauty Device is a portable, non-sterile, reusable device designed to achieve the aesthetic effect. It consists of main unit, charging cable, cleaning flannelette, storage bag, instrument base and user manual. The device is supplied by internal rechargeable lithium battery, which can be recharged by external charger through the Type-C charging cable. The device is un-usable when charging.
The device is only home environment use, which has two massage heads, and three LED light mode (Amber/ Red/ Blue lights are output independently) to provides following functions:
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- a. Amber, Red and Blue LED irradiation function. The device outputs amber light with the wavelength of 605±10nm, and red light with the wavelength of 630±10mm. It is used to illuminate facial skin with narrow spectral bandwidth light and treat facial wrinkles. Also, it outputs blue light with the wavelength of 415±10nm and is used to illuminate facial skin with narrow spectral bandwidth light and treat mild to moderate inflammatory acne. (Cleared under K241718)
- b. Hot compress and vibration function. The device generates different intensity of vibration by a builtin motor to relax the facial skin, and also, the massage head is heated to 40±1℃, making the facial skin feel warm to relax and soothe the facial skin. (The vibration is classified as class I and not need for 510K, and the hot compress is not for medical purpose). (Cleared under K241718)
- c. MS-Micro current stimulation function. The device has two electrode massage heads to do facial stimulation.
V. Indications for Use
Micro-current Facial Beauty Device is intended for the treatment of facial wrinkles, and mild to moderate inflammatory acne. (cleared under K241718)
Micro-current Facial Beauty Device is a handheld portable device for over the counter aesthetic use including facial and neck stimulation.
VI. Comparison of Technological Characteristics With the Predicate Device
The Micro-current Facial Beauty Device has the same intended use as the predicates. The technological characteristics, features, specifications, materials are similar to the predicate devices. Any minor differences between the subject device and the listed predicate devices do no raise any issues of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate devices for its intended use.
Therefore, the Micro-current Facial Beauty Device may be found substantially equivalent to its predicate devices.
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| Elements of
| Comparison | Subject Device | Primary Predicate Device | Predicate Device 1 | Predicate Device 2 | Remark |
|---|---|---|---|---|---|
| Device Name | |||||
| and Model | Micro-current Facial | ||||
| Beauty Device | |||||
| Model: AM-810B, AM- | |||||
| 810W, AM-812B, AM- | |||||
| 812W | 2 Face / Face Evolution | Micro-current vibration facial | |||
| cold and hot service | |||||
| Model: TPML-100 | BEAGANK 4T PLUS | / | |||
| 510(k) Number | Pending | K171821 | K213039 | K233010 | / |
| Product code | NFO | NFO, OHS, OLP | NFO, OLP | NFO | Same |
| Device | |||||
| classification | Class II | Class II | Class II | Class II | Same |
| OTC | |||||
| or | |||||
| prescription | OTC | OTC | OTC | OTC | Same |
| Intended Use | Micro-current Facial | ||||
| Beauty Device is a | |||||
| handheld portable device | |||||
| for over the counter | |||||
| aesthetic use including | |||||
| facial and neck | |||||
| stimulation. | 2 Face / Face Evolution is a | ||||
| hand-held device for over- | |||||
| the counter aesthetic | |||||
| purposes. | |||||
| (1) The EMS mode is | |||||
| indicated for facial | |||||
| stimulation; | |||||
| (2) The Photon mode: The | |||||
| red light is intended for the | |||||
| treatment of periorbital | |||||
| wrinkles and the blue light | |||||
| is intended for the treatment | |||||
| of the mild to moderate | |||||
| inflammatory acne. | Micro-current facial cold and | ||||
| hot service is an over the | |||||
| counter device that is | |||||
| indicated for the treatment of | |||||
| mild to moderate | |||||
| inflammatory acne and facial | |||||
| stimulation for the over the | |||||
| counter aesthetic use. | The BEAGANK 4T | ||||
| PLUS is a handheld | |||||
| portable device for | |||||
| overthe-counter | |||||
| aesthetic use including | |||||
| facial and neck | |||||
| stimulation. | Same | ||||
| Elements of | |||||
| Comparison | Subject Device | Primary Predicate Device | Predicate Device 1 | Predicate Device 2 | Remark |
| Dimensions | AM-810B, AM-810W: | ||||
| 1358539mm | |||||
| AM-812B, AM-812W: | |||||
| 1109268mm | 158mm56mm51.5mm | 188(L)×50(W)×55(H)mm | / | Different | |
| Weight | AM-810B, AM-810W: | ||||
| 118g | |||||
| AM-812B, AM-812W: | |||||
| 130g | 200g | 233g | 136g | ||
| Treatment area | Face and neck | Entire Face | Facial skin | Facial and neck or body | |
| skin | Same | ||||
| Software control | YES | YES | YES | YES | Same |
| Handheld | YES | YES | YES | YES | Same |
| Power source | Adapter input: 5V=0.5A | ||||
| Internal battery: | |||||
| 3.7V/600mAh | DC 3.7V 2200mAh | Charger (not included) input: | |||
| DC 5V, 1A | |||||
| Internal battery: 3.7Vd.c. | |||||
| 900mAh | Internal rechargeable | ||||
| Lithium-ion battery | Similar | ||||
| Battery | Lithium battery | Battery | Lithium battery | Lithium battery | Same |
| Micro-current Stimulation Function | |||||
| Waveform Type | Biphasic pulsed square | Pulsed Biphasic, Modulated | Bi-phase square-wave pulse | Rectangle, biphasic | Same |
| Elements of | |||||
| Comparison | Subject Device | Primary Predicate Device | Predicate Device 1 | Predicate Device 2 | Remark |
| wave | Square | asymmetric | |||
| Maximum | |||||
| Output Voltage | 225mV @500Ω | ||||
| 900mV @2kΩ | |||||
| 3.60V @10kΩ | 310mV @ 500Ω | ||||
| 1.16V @ 2kΩ | |||||
| 5.56V @ 10kΩ | 225 mV @500Ω, ±10% | ||||
| 900 mV @2kΩ, ±10% | |||||
| 3.86 V @10kΩ, ±10% | Mode 1: | ||||
| 127mV@500Ω, ±15% | |||||
| 515mV@2kΩ, ±15% | |||||
| 1.83V@10kΩ, ±15% | Similar | ||||
| Maximum | |||||
| Output Current | 450μA @500Ω | ||||
| 450μA @2kΩ | |||||
| 360μA @10kΩ | 620μA @ 500Ω | ||||
| 580μA @ 2kΩ | |||||
| 556μA @ 10kΩ | 450 μA @500Ω, ±10% | ||||
| 450 μA @2kΩ, ±10% | |||||
| 386 μA @10kΩ, ±10% | Mode 1: | ||||
| 0.19mA@500Ω,±15% | |||||
| 0.18mA@2kΩ, ±15% | |||||
| 0.16mA@10kΩ,±15% | |||||
| Pulse Width | 4ms | 60ms | 4ms | Mode 1: 265µs | Same |
| Output | |||||
| Frequency | 57Hz | 8.333Hz | 57±3Hz | Mode 1: 3.80kHz | Same |
| Net charge | 0 µC @ 500Ω | 0 µC @ 500Ω | Mode 1: 0.025µC | Same | |
| Maximum | |||||
| Current Density | AM-810B, AM-810W: | ||||
| 0.10mA/cm²@500Ω | |||||
| AM-812B, AM-812W: | |||||
| 0.06mA/cm²@500Ω | 0.330mA/cm² @500 Ω | ||||
| (The Minimum Electrode | |||||
| Size: 2.91cm²) | 0.49mA/cm²@500Ω | Mode 1: | |||
| Standard:0.15mA/cm² | |||||
| Scalp: 0.53mA/cm² | Similar | ||||
| Elements of | |||||
| Comparison | Subject Device | Primary Predicate Device | Predicate Device 1 | Predicate Device 2 | Remark |
| Maximum | |||||
| Power Density | AM-810B, AM-810W: | ||||
| $0.0117mW/cm^2@500Ω$ | |||||
| AM-812B, AM-812W: | |||||
| $0.0072mW/cm^2@500Ω$ | $4.34µW/cm^2 @500Ω$ | ||||
| (The Minimum Electrode | |||||
| Size: $2.91cm^2$ ) | $0.20mW/cm^2@ 500Ω$ | Small: $1.36mA/cm^2$ | |||
| Mode 1: | |||||
| $8.51μW/cm^2$ | |||||
| With a wet cotton pad | |||||
| $11.39μW/cm^2$ | |||||
| Treatment | |||||
| frequency | • MS-Micro current | ||||
| stimulation mode: It is | |||||
| recommended to use | |||||
| the product 10-15 | |||||
| minutes at a time / 2-3 | |||||
| times a week. | EMS Mode (5 minutes) | ||||
| Photon Mode (5~7 minutes) | Hold treatment face in contact | ||||
| with skin. Apply blue light for | |||||
| 3minutes per skin area, | |||||
| followed by red light for 3 | |||||
| minutes per skin area. Can be | |||||
| used daily. |
Apply EMS micro-current for
15 minutes per day. Can be
used for 2-3 times per week. | 5 minutes | Same |
| Main Materials | ABS, PC | ABS Plastic & Stainless
Steel | PC, ABS, Stainless steel
(SUS 304) | ABS | Different, but solved by
biocompatibility test |
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VII.Performance Data
The following performance data were provided in support of the substantial equivalence determination.
1) Biocompatibility Testing
The biocompatibility evaluation for the body-contacting components of the Micro-current Facial Beauty Device was conducted in accordance with the "Use of International Standard ISO 10993-1. 'Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process, Document Issued on September 4, 2020", as recognized by FDA. The following testing was performed to, and passed, including:
-
ISO 10993-5: 2009, Biological evaluation of medical devices -Par t 5: Tests for in vitro cytotoxicity
-
ISO 10993-10: 2021, Biological evaluation of medical devices Part 10: Tests for skin sensitization
-
ISO 10993-23: 2021, Biological evaluation of medical devices Part 23: Tests for irritation
2) Electrical Safety
-
IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
-
IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
-
IEC 60601-1-11 Medical Electrical Equipment -Part 1-11: General Requirements for Basic Safety and Essential Performance -Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
-
IEC 60601-2-10 Medical electrical equipment Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
-
IEC 62133-2, Secondary cells and batteries containing alkaline or other non-acid electrolytes -Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
4) Software Verification and Validation
Software documentation consistent with Basic Documentation Level of concern was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.
VIII. Conclusions
Based on the above analysis and non-clinical tests performed, it can be concluded that the subject device is as safe, as effective, and performs as well as the legally marketed predicate devices.