(136 days)
No
The summary describes a microcurrent device with a touchscreen interface for setting parameters and guiding the user, but there is no mention of AI or ML capabilities for analysis, decision-making, or adaptive treatment. The performance studies focus on electrical safety, biocompatibility, and software validation, not on the performance of an AI/ML algorithm.
No.
The device is indicated for aesthetic use and skin stimulation, which are cosmetic purposes, not therapeutic ones.
No
The device is indicated for aesthetic use, including facial and neck stimulation or body skin stimulation, and delivers microcurrent for aesthetic purposes, not for diagnosis.
No
The device description explicitly details physical hardware components: "MyoLight Microcurrent Handpieces" and a "main control unit" with a "color touch screen." These components deliver the microcurrent and facilitate user interaction, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is explicitly stated as "aesthetic use, including facial and neck stimulation or body skin stimulation." This describes a device used for cosmetic or therapeutic purposes applied to the body's surface, not for examining specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details handpieces that deliver microcurrent for aesthetic use. This aligns with a physical therapy or aesthetic device, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. There is no indication of providing diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to gain information about a person's health status. This device operates on the human body for aesthetic purposes.
N/A
Intended Use / Indications for Use
The device is indicated for aesthetic use, including facial and neck stimulation or body skin stimulation.
Product codes (comma separated list FDA assigned to the subject device)
NFO
Device Description
The subject device, the MyoLight Microcurrent Handpieces are intended to be used together with a main control unit that is equipped with a color touch screen that significantly facilitates the use of the device. There are two MyoLight Microcurrent Handpieces that connect to the main unit. The small handpiece (diameter: 3.9 cm, Length: 14 cm) is generally used on the face and the large handpiece (diameter: 6.2 cm, Length: 15 cm) is generally used on the body. The handpieces are different in dimensions but not function. The handpieces contain the electrodes that deliver microcurrent for aesthetic use.
The subject device is intended to be used together with a main control unit that is equipped with a color touch screen that significantly facilitates the use of the handpieces. The on-screen information guides the user step-bystep through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen of the device. During the therapy the device displays information about therapy type, remaining therapy time and main therapy parameters on the screen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Face, Neck, and Body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The product is only sold to professionals licensed to administer the treatments including aestheticians, med spas, plastic surgeons and dermatologists and other licensed professionals. It is not intended to be sold to the consumer or for home 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)
Non-clinical tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device. The following tests were conducted:
-
IEC 60601-1:2005/A1:2012 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance.
- IEC 60601-1-2:2014/EN 60601-1-2:2015, Medical electrical equipment- Part 1-2: General requirements for basic A safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests.
-
IEC 60601-2-10 Edition 2.1 2016-04 Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators.
-
Biocompatibility Tests per ISO 10993 and FDA Guidance.
-
Software Validation & Verification Test.
-
Bench Testing to verify the performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 10, 2025
Raja Trading Company, Inc. % Yolando Smith Smith Assoicates 1469 Harwell Ave Crofton, Maryland 21114
Re: K243063
Trade/Device Name: Myolight Microcurrent Handpiece Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NFO Dated: January 15, 2025 Received: January 15, 2025
Dear Yolando Smith:
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.
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"
1
(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 OS 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 Rue"). 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-devices/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 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).
2
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
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
Myolight Microcurrent Handpiece
Indications for Use (Describe)
The device is indicated for aesthetic use, including facial and neck stimulation or body skin stimulation.
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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4
510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of 21CFR Section 807.92.
510(k) Number: K243063
1. Date of Preparation
2/7/2025
2.
| Name: | RAJA Trading Company Inc. |
|---|---|
| Address: | 2801 Juniper Street, Suite 2, Fairfax, VA 22031 |
| Contact Person: | Robert J. Adipietro |
| Title: | Vice President |
| Telephone: | 561-868-4600 |
| Fax: | 561-258-0207 |
| Email: | rja@rajamedical.com |
3. Identification of the Proposed Device
| Trade Name: | MyoLight Microcurrent Handpiece |
|---|---|
| Common Name: | Microcurrent Stimulator |
| Classification Name: | Stimulator, Transcutaneous Electrical, Aesthetic Purpose |
| Classification: | Class II |
| Product Code: | NFO |
| Regulation Number: | 21 CFR 882.5890 |
| Review Panel: | Neurology |
| Attachment | Regulation Name | Regulation No. | Product
code | Class |
|-------------------------------------|--------------------------------------------------------------|----------------|-----------------|-------|
| MyoLight Microcurrent
Handpieces | Stimulator, Transcutaneous
Electrical, Aesthetic Purposes | 882.5890 | NFO | 2 |
Identification of Predicate Devices 4.
| Primary
Predicate Device | Manufacturer | Trade Name | Product Code | 510K
Number |
|----------------------------------|----------------------|-------------------------------------|--------------|----------------|
| Aesthetic TENS
Device | BTL Industries, Inc. | BTL-785BNF Handpiece | NFO | K232172 |
| Reference Predicate
Device #1 | Manufacturer | Trade Name | | 510K
Number |
| Aesthetic TENS
Device | Salton, Inc. | Rejuvenique Facial Toning
System | NFO | K011935 |
| Reference Predicate
Device #2 | Manufacturer | Trade Name | | 510K
Number |
| Aesthetic TENS
Device | Avazzia, Inc. | EZZI-LIFT | NFO | K191951 |
5. Product Description
The subject device, the MyoLight Microcurrent Handpieces are intended to be used together with a main control unit that is equipped with a color touch screen that significantly facilitates the use of the device. There are two MyoLight Microcurrent Handpieces that connect to the main unit. The small handpiece (diameter: 3.9 cm, Length: 14 cm) is generally used on the face and the large handpiece (diameter: 6.2 cm, Length: 15 cm) is generally used on the body. The handpieces are different in dimensions but not function. The handpieces contain the electrodes that deliver microcurrent for aesthetic use.
5
The subject device is intended to be used together with a main control unit that is equipped with a color touch screen that significantly facilitates the use of the handpieces. The on-screen information guides the user step-bystep through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen of the device. During the therapy the device displays information about therapy type, remaining therapy time and main therapy parameters on the screen.
The product is only sold to professionals licensed to administer the treatments including aestheticians, med spas, plastic surgeons and dermatologists and other licensed professionals. It is not intended to be sold to the consumer or for home use.
6. Indications for Use
The device is indicated for aesthetic use, including facial and neck or body skin stimulation.
| Specifications | Subject Device | Primary
Predicate Device | Reference
Predicate
Device # 1 | Reference
Predicate
Device # 2 |
|---------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K243063 | K232172 | K011935 | K191951 |
| Manufacturer | RAJA Trading
Company | BTL Industries, Inc | Salton, Inc. | Avazzia, Inc. |
| Device Name | MyoLight
Microcurrent
Handpiece | BTL-785BNF
Handpiece | Rejuvenique
Facial Toning
System | EZZI-LIFT |
| Classification &
Subsequent Product
Codes | NFO | NFO | NFO | NFO |
| Regulation Number | 882.5890 | 882.5890 | 882.5890 | 882.5890 |
| Classification Name: | Transcutaneous
Electrical Never
Stimulator for Pain
Relief | Transcutaneous
Electrical Never
Stimulator for Pain
Relief | Transcutaneous
Electrical Never
Stimulator for
Pain Relief | Transcutaneous
Electrical Never
Stimulator for
Pain Relief |
| Common Name | Esthetic TENS Device | Esthetic TENS
Device | Esthetic TENS
Device | Esthetic TENS
Device |
| Indications for use | The device is indicated
for aesthetic use
including facial and
neck or body skin
stimulation. | The device is
indicated for
aesthetic use
including facial and
neck or body skin
stimulation. | Indicates for
Cosmetic Use | The Avazzia
OTC TENS for
aesthetics,
model BEST-
AVI™ : EZZI-
LIFTTM Device
is indicated for
over-the-
counter
aesthetic use
including facial
and neck
stimulation or
body skin
stimulation. |
| Specifications | Subject Device | Primary
Predicate Device | Reference
Predicate
Device # 1 | Reference
Predicate
Device # 2 |
| Anatomic Sites | Face, Neck, and Body | Face, Neck, and
Body | Face | Face, Neck, and
Body |
| Principal of Operation | Handpieces with
electrodes that deliver
electrical stimulation
attached to a main
body that contains the
power supplies, the
microprocessor control
unit, and the touch-
screen user interface. | Handpieces with
electrodes that
deliver electrical
stimulation attached
to a main body that
contains the power
supplies, the
microprocessor
control unit, and the
touch-screen user
interface. | Face Mask with
electrodes that fit
over users face
that delivers
electrical
stimulation
connected to a
control unit. | Handheld
portable device
with electrodes,
batteries and
user controls. |
| User Interface | LCD Touch Screen on
main Control Unit with
Power Source and
Microprocessor
controlled | LCD Touch Screen
on main Control
Unit with Power
Source and
Microprocessor
controlled | Control Unit
with Power
Source and
Microprocessor
controlled. | LEDs and
switches |
| Compliance with
Voluntary Standards | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-10
ISO 14971
IEC 62366 | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-10
ISO 14971
IEC 62366 | Not Available | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-10
ISO 14971
IEC 62366 |
| Compliance with 21
CFR 898 | YES | YES | YES | YES |
| Power Sources | Mains Power 110 -
120, 220 - 240 VAC,
50- 60 Hz | Mains Power
100-240V, 50-60
Hz | 9V battery | Two 1.5 V AA
batteries |
| Patient leakage
current: Normal
Condition | Compliant with IEC
60601-1 leakage
current requirements | Compliant with IEC
60601-1 leakage
current
requirements | Not Available | Compliant with
IEC 60601-1
leakage current
requirements |
| Method of Channel
Isolation | Compliant with IEC
60601-1 isolation
requirements | Compliant with IEC
60601-1 isolation
requirements | Electrode Group
selected by
relays | Compliant with
IEC 60601-1
isolation
requirements |
| Synchronous or
Alternating Output | Both | Both | Alternating | Not Available |
| Software / Firmware
/ Micro-Processor
Control? | Yes | Yes | Yes | Yes |
| Number of Output
Modes | 1 | 1 | 1 | 4 |
| Specifications | Subject Device | Primary
Predicate Device | Reference
Predicate
Device # 1 | Reference
Predicate
Device # 2 |
| Regulated Current or
Regulated Voltage | Regulated Voltage | Regulated Voltage | Regulated
Voltage | Regulated
Voltage |
| Housing Materials
and Constructions | Molded PC-ABS
plastic material with
screw assembly
construction. | PCBs and leads
inside plastic, or
foam case housing. | ABS Plastic,
latch assembly | PCBs inside
plastic case
housing |
| Energy Type | Electrical Stimulation | Electrical
Stimulation | Electrical
Stimulation | Electrical
Stimulation |
| Voltage Current Level | Yes - Uncalibrated
Knob | Yes | Yes -
Uncalibrated
Knob | Not Available |
| Handpiece
Dimensions | Handpiece #1: 62mm x
147 mm
Handpiece #2: 39mm x
139.5 mm | 38.98" x 53.94" x
34.65" | 4.5" X 3" X
1.25" | 2.6" X 4.7" X
1.35" |
| Handpiece Weight | Handpiece #1: 1100 g
Handpiece #2: 720 g | 2500 g | 80 grams | 5.4 oz. |
| Recommended
Treatment Time/
Timer range | 20 Minutes
Recommended
Treatment Time | 20 Minutes Timer
range | 20/16 minutes
Timer Range | Not Available |
| Output Modes | 1 | 1 | 1 | 4 |
| Automatic Shut Off | YES | Unknown | YES | YES |
| Patient Contact | YES | YES | YES | YES |
| Contact Material | Stainless Steel 304
PMMA | Conductive Ink
(Silver) | PCB Mask with
Gold Plated
Brass Electrodes | Stainless Steel
316 |
| Waveform Shape | Pulsed Biphasic
rectangular modulated
by trapezoidal | Pulsed Biphasic
rectangular
modulated by
trapezoidal | Pulsed Biphasic
rectangular | Positive square
wave followed
by a damped
sinusoidal
waveform of
variable
duration
depending on
damping and
body loading |
| Max output voltage
[V] (±20%) at
500 Ω
2,000 Ω
10,000 Ω | 30V @ 500 Ω
33V @ 1,000 Ω | BTL-785-2, -8, -9
Max. 48,5V @ 10 -
373 Ω
48,5V @ 500 Ω
48,5V @ 2,000 Ω
0 @ 10,000 Ω | 18V @ 500 Ω
24V @ 1,000 Ω | 42V @ 500 Ω |
| Specifications | Subject Device | Primary
Predicate Device | Reference
Predicate
Device # 1 | Reference
Predicate
Device # 2 |
| | 35V @ 10,000 Ω | BTL-785-1, -7
Max. 48,5V @ 10 -
757 Ω
48,5V @ 500 Ω
48,5V @ 2,000 Ω
0 @ 10,000 Ω | 28V @ 10,000 Ω | 122V @ 2,000 Ω
348V @ 10,000 Ω |
| Max output current
(+/-20%) a
500 Ω
2,000 Ω
10,000 Ω | 60 mA @ 500 Ω
33 mA @ 1000 Ω
3.5 mA @ 10,000 Ω | BTL-785-2, -8, -9
Max. 130 mA @ 10
- 373 Ohm
97 mA @ 500 Ω
24 mA @ 2000 Ω
0 mA @ 10000 Ω
BTL-785-1, -7
Max. 64 mA @ 10 -
757 Ω
64 mA @ 500 Ω
24 mA @ 2000 Ω
0 mA @ 10000 Ω | 37.6 mA @ 500 Ω
12.4 mA @ 1000 Ω
2.8 mA @
10,000 Ω | Max. 0.5 mA
0.363 mA @
500 Ω
0.117 mA @
2000 Ω
0.038 mA @
10000 Ω |
| Max current density at
500 Ω [μA/mm²] | 82 µA/mm² | BTL-785-2 - 243
μA/mm²
BTL-785-8 - 335
μA/mm²
BTL-785-9 - 277
μA/mm²
BTL-785-1 - 168
μA/mm²
BTL-785-7 - 337
μA/mm² | 464 μA/ mm² | Built-in, Y
Brush: 8
μA/mm²
Pencil: 190
μA/mm² |
| Max average power
density at 500 Ω
[W/cm²] | 0.012W/ cm² | BTL-785-2 - 0.047
W/cm²
BTL-785-8 - 0.065
W/cm²
BTL-785-9 - 0.054
W/cm²
BTL-785-1 - 0.033
W/cm²
BTL-785-7 - 0.065
W/cm² | 0.0023 W/ cm² | Built-in, Y
Brush: 0.0005
W/cm²
Pencil: 0.0035
W/cm² |
| Net Charge per pulse | 0 µC (Pulse is biphasic
symmetrical) | 0 µC (Pulse is
biphasic
symmetrical) | 0 µC | 4 µC |
| Max phase charge per
pulse at 500 Ω [μC] | 23 µC | BTL-785-2, -8, -9
15 µC | 11.3 µC | 10 µC |
| Specifications | Subject Device | Primary
Predicate Device | Reference
Predicate
Device # 1 | Reference
Predicate
Device # 2 |
| | | BTL-785-1, -7
10 μC | | |
| Duration of primary
[μs]
(depolarizing phase) | 128 μs, 256 μs, 384 μs | 80 μs | Not Available | 500 μs |
| Pulse Duration [μs] | 128 μs, 256 μs, 384 μs | 160 μs | 300 μs | 1100 μs |
| Frequency [Hz] | 1 ~ 63 Hz | 250 Hz | 8 Hz | 15-121 Hz |
7. Substantially Equivalent (SE) Comparison
6
7
8
9
Similarities
The subject device is similar to the predicate product in:
- same classification information,
- same indications and intended use,
- same principle of operation
- same performance effectiveness and performance safety as the primary predicate device. ●
- same waveform shape
- . same maximum average power density
- substantially equivalent maximum output voltage
- substantially equivalent output current .
Differences
The differences do not affect the performance and effectiveness of the subject device. Differences in Maximum Voltage, Maximum Current, Frequency, Pulse Duration, Phase Charge, and Current Density do not affect the performance and safety of the subject device.
Therefore, the MyoLight Microcurrent Handpiece device is substantially equivalent to the predicate device.
8. Non-Clinical Testing
Non-clinical tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device. The following tests were conducted:
-
IEC 60601-1:2005/A1:2012 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance.
- IEC 60601-1-2:2014/EN 60601-1-2:2015, Medical electrical equipment- Part 1-2: General requirements for basic A safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests.
-
IEC 60601-2-10 Edition 2.1 2016-04 Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators.
-
Biocompatibility Tests per ISO 10993 and FDA Guidance.
-
Software Validation & Verification Test.
-
Bench Testing to verify the performance.
9. Clinical Testing
Not Applicable
10. Conclusion
Based on the comparison and analysis above, the proposed subject device is Substantially Equivalent (SE) to the predicate device.