Low-frequency Multi-function physiotherapy instrument

K172837 · Shenzhen Osto Technology Co., Ltd. · NUH · Nov 26, 2018 · Neurology

Device Facts

• Record ID: K172837
• Device Name: Low-frequency Multi-function physiotherapy instrument
• Applicant: Shenzhen Osto Technology Co., Ltd.
• Product Code: NUH · Neurology
• Decision Date: Nov 26, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

PMS (Mode 1) It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. TENS (Mode 2) To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.

Device Story

Physiotherapy instrument (models AST-2011A, AST-2011B, AST-802B) is an over-the-counter electronic stimulator. Device delivers electrical pulses to skin via two electrode pads connected to a main unit. User operates device via ON/OFF switch, mode selection, intensity keys, and time selection keys. LCD screen displays mode, intensity, and remaining time. Device operates in two modes: PMS for muscle conditioning and TENS for pain relief. Healthcare provider consultation recommended before use. Output is voltage-controlled, symmetric, biphasic pulsed current. Device provides temporary pain relief or muscle performance improvement, benefiting patients by allowing self-administered therapy for muscle strain or soreness.

Clinical Evidence

Bench testing only. Evaluated for electrical safety (IEC 60601-1, 60601-1-11, 60601-2-10), electromagnetic compatibility (IEC 60601-1-2), biocompatibility (ISO 10993-5, 10993-10), usability (IEC 62366), and software validation. Waveform output verified against FDA guidance for TENS and muscle stimulators.

Technological Characteristics

ABS plastic housing; voltage-controlled; symmetric biphasic pulsed waveform; 1 channel; 2 electrode pads; powered by 5Vdc adapter (100-240Vac input); Type BF applied part; microprocessor-controlled; LCD interface. Standards: IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2, ISO 10993, IEC 62366.

Indications for Use

Indicated for healthy individuals to improve/facilitate muscle performance (PMS) and for temporary relief of pain associated with sore/aching muscles in shoulder, waist, back, neck, arm, leg, and foot due to exercise or household work (TENS).

Regulatory Classification

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.

Predicate Devices

• Health Expert Electronic Stimulator (K133929)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out as "U.S. Food & Drug Administration".

November 26, 2018

Shenzhen OSTO Technology Co., Ltd. % Cecilia Ceng Manager Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road Guangzhou Science Park Guangzhou. 510006 Cn

Re: K172837

Trade/Device Name: Low-frequency Multi-function physiotherapy instrument Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: October 17, 2018 Received: October 26, 2018

Dear Cecilia Ceng:

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.

{1}------------------------------------------------

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Timothy A. Marjenin -S

Carlos L. Peña, PhD, MS For Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K172837

Device Name

Physiotherapy instrument (Models: AST- 2011A, AST- 2011B, and AST-802B)

Indications for Use (Describe)

PMS (Mode 1)

It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.

TENS (Mode 2)

To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.

| 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."

{3}------------------------------------------------

# Chapter 5. 510(k) Summary

# 510(k) Summary

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

# 1. Submitter's Information

510(k) Owner's Name: Shenzhen OSTO Technology Co., Ltd. Establishment Registration Number: Applying Address: No.43 Longfeng Road, Xinsheng Community, Longgang Street Longgang District, Shenzhen City Guangdong Province, CHINA Tel: [phone] Fax: [phone] Contact Person: Li Yang (General Manager) Email: [e-mail]

### Application Correspondent:

Contact Person: Ms. Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Address: Suite 306, Kecheng Mansion, No.121 Science Road, Guangzhou Science Park, Guangzhou 510663, China Tel: [phone] Email: [e-mail]

# 2. Subject Device Information

Type of 510(k): Traditional Trade/Device Name: Physiotherapy instrument, Models: AST-2011A, AST-2011B, AST-802B Common Name: Electronic Simulator Classification Name: 1. Stimulator. Nerve. Transcutaneous. Over-The-Counter (NUH) 2. Stimulator, Muscle, Powered, For Muscle Conditioning (NGX) Review Panel: Neurology Product Code: NUH, NGX Regulation Number: 21 CFR 882.5890, 890.5850 Regulatory Class: II

### 3. Predicate Device Information

Sponser: Shenzhen OSTO Technology Company Limited Trade Name: Health Expert Electronic Stimulator Common Name: Electronic Stimulator Classification name: Stimulator, Nerve, Transcutaneous, Muscle, Powered, For Muscle Conditioning, Over-The-Counter 510(k)number: K133929 Review Panel: Neurology, Physical Medicine Product Code: NUH, NGX Regulation Number: 882.5890, 890.5850

{4}------------------------------------------------

Requlation Class: II

# 4. Device Description

Physiotherapy instrument has 2 operation modes and one channel, after insert the electrode wire of the electrode pads, just put the electrode pads on the same side of your body, for shoulder, waist, back, back of the neck, arm, leg or foot (depends on your need, please consult your doctor before using if need), which can give certain electrical pulse through 2 pieces of electrode pads on the skin.

The electronic stimulatory module has the operating elements of ON/OFF Switch, Display screen, Mode Selection key, Intensity enhancement/weakening keys, language switch button and time selection keys. The LCD display screen can show selected mode, output intensity of body and/or sole, time remaining of an application mode, language display systemy.

The device is equipped with accessories of electrode pads, electrode wire, adapter.

The electrode wire is used to connect the pads to the main unit; the adapter wire is used to connect the adapter to the device.

# 5. Intended Use / Indications for Use

PMS (Mode 1)

It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. TENS (Mode 2)

To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.

# 6. Test Summary

Physiotherapy instrument, Models: AST-2011B, AST-2011B, AST-802B has been evaluated the safety and performance by lab bench testing as following:

- Electrical safety test according to IEC 60601-1, IEC 60601-1-11 and IEC 60601-2-10 standards �
- � Electromagnetic compatibility test according to IEC 60601-1-2 standard
- � Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards
- � Usability test according to IEC 62366 standard
- � Software verification and validation test according to the requirements of the FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
- � The waveform test has also been conducted to verify the output specifications of the device according to "Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use and Guidance for Powered Muscle Stimulator for Muscle Conditioning".

# 7. Comparison to predicate device and conclusion

The technological characteristics, features, specifications, mode of operation, and intended use of Electronic Muscle Stimulator is substantially equivalent to the predicate devices quoted above. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.

# Comparison in Detail(s):

| Elements of<br>Comparison | Subject Device | Predicate Device | Verdict | |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|--------------|
| Elements of<br>Comparison | Subject Device | Predicate Device | Verdict | |
| Company | Shenzhen OSTO<br>Technology Co., Ltd | Shenzhen OSTO Technology<br>Co., Ltd | -- | |
| Trade Name | Physiotherapy instrument | Health Expert Electronic<br>Stimulator | -- | |
| Model | AST-2011A, AST-2011B,<br>AST-802B | AST-300C, AST-300D | -- | |
| Classification<br>Name | Stimulator, Nerve,<br>Transcutaneous, Over-<br>The-Counter | Stimulator, Nerve,<br>Transcutaneous, Over-The-<br>Counter | -- | |
| 510(k) Number | Applying | K133929 | -- | |
| Product Code | NUH, NGX | NUH, NGX | SE | |
| Intended Use /<br>Indications for Use | PMS (Mode 1)<br>It is intended to stimulate<br>healthy muscles in order<br>to improve and facilitate<br>muscle performance.<br>TENS (Mode 2)<br>To be used for temporary<br>relief of pain associated<br>with sore and aching<br>muscles in the shoulder,<br>waist,<br>back, back of the neck,<br>arm, leg, and foot due to<br>strain from exercise or<br>normal household work<br>activities<br>by applying current to<br>stimulate nerve. | PMS (Mode 1~8)<br>It is intended to stimulate<br>healthy muscles in order to<br>improve and facilitate muscle<br>performance.<br>TENS (Mode 9~25)<br>To be used for temporary<br>relief of pain associated with<br>sore and aching muscles in<br>the shoulder, waist,<br>back, back of the neck, arm,<br>leg, and foot due to strain<br>from exercise or normal<br>household work activities<br>by applying current to<br>stimulate nerve. | SE | |
| Power Source | Adaptor Input: 100-<br>240Vac, 50-60Hz, 0.1A<br>Output: 5Vdc, 1A<br>Unit Input: 5Vdc, 1A | Adaptor Input: 100-240Vac,<br>50-60Hz, 0.1A<br>Output: 5Vdc, 1A<br>Unit Input: 5Vdc, 1A | SE | |
| -Method of Line<br>Current Isolation | Type BF Applied Part | Type BF Applied Part | SE | |
| Patient<br>Leakage<br>Current | Normal Condition:<br>AC: 54.5μA, DC: 0.5μA<br>Single Fault Condition:<br>AC:120.0μA, DC: 0.6μA | Normal Condition:<br>AC: 54.5μA, DC: 0.5μA<br>Single Fault Condition:<br>AC:120.0μA, DC: 0.6μA | SE | |
| Number of Output<br>Modes | 2 | 25 | SE<br>Note 2 | |
| Number of<br>Output Channels: | 1 | 2 | SE<br>Note 2 | |
| Elements of<br>Comparison | Subject Device | Predicate Device | Verdict | |
| - Synchronous or<br>Alternating? | N/A | Synchronous | SE<br>Note 2 | |
| - Method of<br>Channel Isolation | N/A | Voltage Transform<br>Isolation<br>"BODY▼" and<br>"BODY▼" buttons for<br>body channel,<br>"SOLE▲" and<br>"SOLE▼" buttons for<br>feet channel | SE<br>Note 2 | |
| Regulated Current<br>or Regulated<br>Voltage? | Voltage Control | Voltage Control | SE | |
| Software/Firmwar<br>e/Microprocessor<br>Control? | Yes | Yes | SE | |
| Automatic<br>Overload Trip? | No | No | SE | |
| Automatic No-Load<br>Trip? | No | No | SE | |
| Automatic Shut<br>Off? | Yes | Yes | SE | |
| Patient Override<br>Control? | No | No | SE | |
| Indicat<br>or<br>Displa<br>y: | - On/Off<br>Status? | Yes | Yes | SE |
| | - Low<br>Battery? | No | No | SE |
| | Voltage/Current<br>Level? | Yes | Yes | SE |
| Timer Range<br>(minutes) | 5-15 min | 25 min | SE<br>Note 3 | |
| Compliance with<br>Voluntary<br>Standards? | No | No | SE | |
| Elements of<br>Comparison | Subject Device | Predicate Device | Verdict | |
| Compliance* with<br>21 CFR 898? | Yes | Yes | SE | |
| Main Unit Weight | 105 g | 2 kg | SE<br>Note 1 | |
| Main Unit<br>Dimension | AST-802B: 156.6 x 74.5 x<br>17.8 mm<br>AST-2011A: 157.03 X<br>72.87 X 23.89 mm<br>AST-2011B: 156.6 x 74.5<br>x 17.8 mm | 428 x 428.8 x 185mm | SE<br>Note 1 | |
| Housing Materials<br>and Construction | Main unit: ABS plastic | Main unit: ABS plastic | SE | |
| Output Specification | | | | |
| Waveform | Pulsed, symmetric,<br>biphasic | Pulsed, symmetric,<br>biphasic | SE | |
| Shape | Rectangular, with<br>interphase interval | Rectangular, with<br>interphase interval | SE | |
| Maximum Output<br>Voltage | 44V±10% @ 500Ω<br>80V±10% @ 2KΩ<br>112V±10% @ 10KΩ | 44V±10% @ 500Ω<br>80V±10% @ 2KΩ<br>112V±10% @ 10KΩ | SE | |
| Maximum Output<br>Current | 88mA±10% @ 500Ω<br>40mA±10% @ 2KΩ<br>11.2mA±10% @ 10KΩ | 88mA±10% @ 500Ω<br>40mA±10% @ 2KΩ<br>11.2mA±10% @ 10KΩ | SE | |
| Pulse Duration | 120µs | 120µs | SE | |
| Pulse frequency | 77.3Hz | 77.3Hz | SE | |
| Symmetrical<br>phases? | Yes | Yes | SE | |
| Phase Duration | 12.94 ms | 12.94 ms | SE | |
| Net Charge (mC<br>per pulse) | 0µC @ 500Ω<br>Method: Balanced<br>waveform | 0µC @ 500Ω<br>Method: Balanced waveform | SE | |
| Maximum Phase<br>Charge, (mC) | 12.78 µC @ 500Ω | 12.78 µC @ 500Ω | SE | |
| Maximum Current<br>Density, (mA/cm²) | 0.235 mA/cm² @ 500Ω | 0.235 mA/cm² @ 500Ω | SE | |
| Maximum Power<br>Density, (W/cm²) | 1.38 mW/cm² @ 500Ω | 1.38 mW/cm² @ 500Ω | SE | |
| Stimulation<br>parameters | See attached table 1 | See attached table 1 | SE | |
| | Elements of<br>Comparison | Subject Device | Predicate Device | Verdict |
| Bur<br>st<br>Mo<br>de | Pulses per<br>burst | 400 | 400 | SE |
| | Bursts per<br>second | 0.63 | 0.63 | SE |
| | Burst<br>duration<br>(seconds) | 2.588 | 2.588 | SE |
| | Duty Cycle<br>[Line (b) x<br>Line (c)] | 1.63 | 1.63 | SE |
| ON Time (seconds) | | 0.6s | 0.6s | SE |
| OFF Time<br>(seconds) | | 0.6s | 0.6s | SE |
| Additional Features | | | | |
| | Environment for<br>operation | Temperature: 5 ~ 45<br>Humidity: 15% - 90%<br>Atmospheric pressure<br>range of 700 hPa to 1 060<br>hPa | Temperature: 5 ~ 45° C<br>Humidity: 20 ~ 65% RH | SE<br>Note 4 |
| | Environment for<br>storage | Temperature: -25 - +70°C<br>Humidity: up to 90%<br>Atmospheric pressure<br>range of 700 hPa to 1 060<br>hPa | Temperature: 0 ~ 45° C,<br>Humidity: 10 ~ 90% RH<br>Electrode Pad: 10~20° C | SE<br>Note 4 |

{5}------------------------------------------------

{6}------------------------------------------------

{7}------------------------------------------------

{8}------------------------------------------------

{9}------------------------------------------------

| Table1 | | | | |
|-----------------------------------|------------------------------|------|------------------------------|-------|
| Output Specification | | | | |
| Pulse Duration and Pulse<br>Cycle | | | | |
| | Note: "T" means Pulse Cycle. | | Note: "T" means Pulse Cycle. | |
| Cycle of<br>Mode 1 | | N/A | | |
| | | | Max | Min |
| Intensity | | | | |
| Peak Voltage (V) (0.5KΩ) | | | 44 V | 0.63 |
| Peak Voltage (V) (2KΩ) | | | 80 V | 2.48 |
| Peak Voltage (V) (10K Ω) | | | 112 V | 11.80 |
| Cycle of<br>Mode 2 | 200T | | 200T | |
| Intensity | Max | Min | Max | Min |
| Peak Voltage (V) (0.5KΩ) | 44 V | 0.63 | 44 V | 0.63 |
| Peak Voltage (V) (2KΩ) | 80 V | 2.48 | 80 V | 2.48 |

{10}------------------------------------------------

| Peak Voltage (V) (10K Ω) | 112 V | 11.80 | 112 V | 11.80 |
|--------------------------|------------------|-------------------------------------------------------|---------------------------------------------|-------|
| Cycle of<br>Mode 3 | | | Image: Sub-mode 5 X 1 1s Sub-mode 6 X 2 | |
| Intensity | | N/A | Max | Min |
| Peak Voltage (V) (0.5KΩ) | | | 44 V | 0.63 |
| Peak Voltage (V) (2KΩ) | | | 80 V | 2.48 |
| Peak Voltage (V) (10K Ω) | | | 112 V | 11.80 |
| Cycle of<br>Mode 4 | | | Image: Sub-mode 6 X 1 0.5s Sub-mode 17 X 10 | |
| Intensity | | N/A | Max | Min |
| Peak Voltage (V) (0.5KΩ) | | | 44 V | 0.63 |
| Peak Voltage (V) (2KΩ) | | | 80 V | 2.48 |
| Peak Voltage (V) (10K Ω) | | | 112 V | 11.80 |
| Cycle of<br>Mode 5 | | | Image: Sub-mode 9 X 1 1s Sub-mode 15 X 10 | |
| Intensity | | N/A | Max | Min |
| Peak Voltage (V) (0.5KΩ) | | | 44 V | 0.63 |
| Peak Voltage (V) (2KΩ) | | | 80 V | 2.48 |
| Cycle of<br>Mode 6 | N/A | Image: Sub-mode 15 X 1 and Sub-mode 16 X 1 with 0.5s | | |
| Intensity | N/A | Max | Min | |
| Peak Voltage (V) (0.5KΩ) | N/A | 44 V | 0.63 | |
| Peak Voltage (V) (2KΩ) | N/A | 80 V | 2.48 | |
| Peak Voltage (V) (10K Ω) | N/A | 112 V | 11.80 | |
| Cycle of<br>Mode 7 | N/A | Image: Sub-mode 5 X 1 and Sub-mode 6 X 1 with 1s | | |
| Intensity | N/A | Max | Min | |
| Peak Voltage (V) (0.5KΩ) | N/A | 44 V | 0.63 | |
| Peak Voltage (V) (2KΩ) | N/A | 80 V | 2.48 | |
| Peak Voltage (V) (10K Ω) | N/A | 112 V | 11.80 | |
| Cycle of<br>Mode 8 | N/A | Image: Sub-mode 18 X 5 and Sub-mode 17 X 5 with 0.05s | | |
| Intensity | N/A | Max | Min | |
| Peak Voltage (V) (0.5KΩ) | N/A | 44 V | 0.63 | |
| Peak Voltage (V) (2KΩ) | N/A | 80 V | 2.48 | |
| Peak Voltage (V) (10K Ω) | N/A | 112 V | 11.80 | |
| Cycle of<br>Mode 9 | N/A | Image: Sub-mode 11 X 5 and Sub-mode 15 X 5 with 0.3s | | |
| Intensity | | Max | Min | |
| Peak Voltage (V) (0.5KΩ) | N/A | 44 V | 0.63 | |
| Peak Voltage (V) (2KΩ) | | 80 V | 2.48 | |
| Peak Voltage (V) (10K Ω) | | 112 V | 11.80 | |
| Cycle of<br>Mode 10 | | Image: Sub-mode 8 X 1, Sub-mode 14 X 10, 0.1s | | |
| Intensity | | Max | Min | |
| Peak Voltage (V) (0.5KΩ) | N/A | 44 V | 0.63 | |
| Peak Voltage (V) (2KΩ) | | 80 V | 2.48 | |
| Peak Voltage (V) (10K Ω) | | 112 V | 11.80 | |
| Cycle of<br>Mode 11 | | Image: Sub-mode 5 X 5, Sub-mode 11 X 5, 1s | | |
| Intensity | | Max | Min | |
| Peak Voltage (V) (0.5KΩ) | N/A | 44 V | 0.63 | |
| Peak Voltage (V) (2KΩ) | | 80 V | 2.48 | |
| Peak Voltage (V) (10K Ω) | | 112 V | 11.80 | |
| Cycle of<br>Mode 12 | | Image: Sub-mode 2 X 1, Sub-mode 6 X 20, 0.5s | | |
| Intensity | | Max | Min | |
| Peak Voltage (V) (0.5KΩ) | | 44 V | 0.63 | |
| | | | | |
| Peak Voltage (V) (2KΩ) | N/A | 80 V | 2.48 | |
| Peak Voltage (V) (10K Ω) | | 112 V | 11.80 | |
| Cycle of<br>Mode 13 | | Image: Sub-mode 11 X 1 Sub-mode 12 X 1 0.3s | | |
| Intensity | | Max…