TENS and EMS Stimulator, TENS Stimulator
Device Facts
| Record ID | K183074 |
|---|---|
| Device Name | TENS and EMS Stimulator, TENS Stimulator |
| Applicant | Astek Technology , Ltd. |
| Product Code | IPF · Physical Medicine |
| Decision Date | Jan 11, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5850 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
TENS Stimulator (Model no .: AK-10M) TENS Stimulator provides 5 types TENS output modes (P1-P5) For TENS mode (1) Symptomatic relief of chronic intractable pain, (2) Post traumatic pain, (3) Post-surgical pain TENS and EMS Stimulator (Model no .: AK3-20 and AK3-25) TENS and EMS Stimulator provides 8 types output modes (P1-P8). TENS/EMS output modes (P1-P6&P8) and TENS output modes (P7) For TENS mode (1) Symptomatic relief of chronic intractable pain, (2) Post traumatic pain, (3) Post-surgical pain For EMS mode (1) Relaxation of Muscle spasm, (2) Increase of local blood flow circulation, (3) Prevention or retardation of disuse atrophy, (4) Muscle re-education, (5) Maintaining or increasing range of motion, (6) Immediate postsurgical stimulation of muscles to prevent venous thrombosis TENS and EMS Stimulator (Model no.: AK3-50) TENS and EMS Stimulator provides 10 types output modes (P0-P9). TENS output modes (P0-P4) and EMS output modes (P5-P9) For TENS mode (1) Symptomatic relief of chronic intractable pain, (2) Post traumatic pain, (3) Post-surgical pain For EMS mode (1) Relaxation of Muscle spasm, (2) Increase of local blood flow circulation, (3) Prevention or retardation of disuse atrophy, (4) Muscle re-education, (5) Maintaining or increasing range of motion, (6) Immediate postsurgical stimulation of muscles to prevent venous thrombosis
Device Story
Device consists of TENS and EMS stimulators (models AK-10M, AK3-20, AK3-25, AK3-50) for pain relief and muscle stimulation. Inputs: user-selected programs via keypad. Operation: device delivers gentle electrical current to nerves/muscles via skin-applied electrodes; intensity adjustable by user. Output: biphasic (AK3 series) or monophasic (AK-10M) electrical waveforms displayed on LCD. Used in physiotherapy clinics; operated by patients or clinicians. Output informs treatment settings; benefits include pain management and muscle rehabilitation.
Clinical Evidence
Bench testing only. No clinical data provided.
Technological Characteristics
Materials: ABS, PMMA. Sensing/Actuation: Electrical stimulation via skin electrodes. Energy: DC battery (3V or 6V). Form factor: Handheld with LCD and keypad. Connectivity: Standalone. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 10993-1. Software: Microprocessor-controlled, rule-based output modes.
Indications for Use
Indicated for patients requiring physiotherapy for symptomatic relief of chronic intractable, post-traumatic, or post-surgical pain (TENS); and for muscle spasm relaxation, increased local blood flow, prevention/retardation of disuse atrophy, muscle re-education, range of motion maintenance/increase, and immediate post-surgical stimulation to prevent venous thrombosis (EMS).
Regulatory Classification
Identification
A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.
Predicate Devices
- FDES 101 (ED401) TENS and EMS Stimulator, FDES 102 (ED402) TENS Stimulator, FDES 103 (ED403) EMS Stimulator (K113010)
Submission Summary (Full Text)
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January 11, 2020
ASTEK Technology Ltd. You-Jhe Lin Engineer No. 118 Taizih Rd., Rende Dist Tainan City, 71741 Taiwan
Re: K183074
Trade/Device Name: TENS and EMS Stimulator, TENS Stimulator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, GZJ Dated: December 10, 2019 Received: December 13, 2019
Dear You-Jhe Lin:
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.
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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/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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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-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.
For Vivek Pinto, Ph.D. Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
## Indications for Use
510(k) Number (if known) K183074
Device Name TENS and EMS Stimulator, TENS Stimulator
Indications for Use (Describe)
TENS Stimulator (Model no .: AK-10M) TENS Stimulator provides 5 types TENS output modes (P1-P5) For TENS mode (1) Symptomatic relief of chronic intractable pain, (2) Post traumatic pain, (3) Post-surgical pain
TENS and EMS Stimulator (Model no .: AK3-20 and AK3-25) TENS and EMS Stimulator provides 8 types output modes (P1-P8). TENS/EMS output modes (P1-P6&P8) and TENS output modes (P7) For TENS mode (1) Symptomatic relief of chronic intractable pain, (2) Post traumatic pain, (3) Post-surgical pain For EMS mode (1) Relaxation of Muscle spasm, (2) Increase of local blood flow circulation, (3) Prevention or retardation of disuse atrophy, (4) Muscle re-education, (5) Maintaining or increasing range of motion, (6) Immediate postsurgical stimulation of muscles to prevent venous thrombosis
TENS and EMS Stimulator (Model no.: AK3-50)
TENS and EMS Stimulator provides 10 types output modes (P0-P9). TENS output modes (P0-P4) and EMS output modes (P5-P9)
For TENS mode
(1) Symptomatic relief of chronic intractable pain, (2) Post traumatic pain, (3) Post-surgical pain For EMS mode
(1) Relaxation of Muscle spasm, (2) Increase of local blood flow circulation, (3) Prevention or retardation of disuse atrophy, (4) Muscle re-education, (5) Maintaining or increasing range of motion, (6) Immediate postsurgical stimulation of muscles to prevent venous thrombosis
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
| 5.1 Type of Submission: | Traditional |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| 5.2 Date of Summary: | 01/11/2020 |
| 5.3 Submitter: | ASTEK Technology Ltd. |
| Address: | No. 118 Taizih Rd., Rende Dist, Tainan City<br>71741, Taiwan |
| Phone: | +886-6-2729488 |
| Fax: | +886-6-2712818 |
| Contact: | You-Jhe Lin (rd@astek-health.com) |
| 5.4 Identification of the Device: | |
| Proprietary/Trade name: | TENS and EMS Stimulator, TENS Stimulator |
| Regulation Description: | Powered muscle stimulator. |
| Review Panel: | Physical Medicine |
| Regulation Number: | 890.5850 |
| Device Class: | II |
| Primary Product Code | IPF |
| Subsequent Product Code | GZJ |
| 5.5 Identification of the Predicate Device (K113010) | |
| Predicate Device Name: | FDES 101 (ED401) TENS and EMS<br>Stimulator, FDES 102 (ED402) TENS<br>Stimulator, FDES 103 (ED403) EMS<br>Stimulator |
| Manufacturer: | Famidoc Technology Co., Ltd |
| Regulation number: | 890.5850 |
| Device Class: | II |
| Primary Product Code | IPF |
| Subsequent Product Code | GZJ |
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### 5.5 Intended Use
#### TENS Stimulator (Model No.: AK-10M) A
TENS Stimulator provides 5 types TENS output modes (P1-P5) For TENS mode
(1) Symptomatic relief of chronic intractable pain. (2) Post traumatic pain. (3) Post-surgical pain
#### TENS and EMS Stimulator (Model No.: AK3-20, AK3-25) A
TENS and EMS Stimulator provides 8 types output modes (P1-P8). TENS/EMS output modes (P1-P6&P8) and TENS output modes (P7) For TENS mode (1) Symptomatic relief of chronic intractable pain. (2) Post traumatic pain. (3)
Post-surgical pain
For EMS mode
(1) Relaxation of Muscle spasm, (2) Increase of local blood flow circulation, (3) Prevention or retardation of disuse atrophy. (4) Muscle re-education. (5) Maintaining or increasing range of motion. (6) Immediate postsurgical stimulation of muscles to prevent venous thrombosis
#### TENS and EMS Stimulator (Model No.: AK3-50) A
TENS and EMS Stimulator provides 10 types output modes (P0-P9). TENS output modes (P0-P4) and EMS output modes (P5-P9)
For TENS mode
(1) Symptomatic relief of chronic intractable pain. (2) Post traumatic pain. (3) Post-surgical pain
For EMS mode
(1) Relaxation of Muscle spasm, (2) Increase of local blood flow circulation, (3) Prevention or retardation of disuse atrophy, (4) Muscle re-education, (5) Maintaining or increasing range of motion, (6) Immediate postsurgical stimulation of muscles to prevent venous thrombosis
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### 5.6 Device description
#### A TENS Stimulator (Model No.: AK-10M) and EMS Stimulator (Model No.: AK3-20, AK3-25 and AK3-50)
The TENS stimulator and TENS and EMS stimulator, are Transcutaneous Electrical Nerve Stimulator for pain relief and/or Electrical Muscle Stimulator. The stimulators send gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin. The parameters of devices are controlled by the press buttons. Its intensity level is adjustable according to the needs of patients.
The four models have similar housing in a molded plastic case with viewable LCD display, an accessible keypad, and accessible battery storage compartment. The LCD is used to display system information to the user. The device is equipped with a keypad composed of push buttons which are located below the LCD that control the program selection, strength, channel, and power.
The TENS and EMS Stimulator (Model No .: AK3-20, AK3-25 and AK3-50) is the comination unit with the TENS and EMS functions; the function can be selected by press buttons. The range of settings is identical in models AK3-20 and AK3-25 while model AK3-50 provides 10 types of output modes.
#### 5.7 Non-clinical Testing
A series of safety and performance tests were conducted on the subject device, TENS and EMS Stimulator, TENS Stimulator.
- . Shelf life test
- . Software validation
- EMC and Electrical Safety test ●
- Performance test
All the test results demonstrate that TENS and EMS Stimulator, TENS Stimulator meets the requirements of its pre-defined acceptance criteria, and is substantially equivalent to the predicate device.
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#### 5.8 Clinical Testing
No clinical test data was used to support the decision of substantial equivalence.
### 5.9 Substantial Equivalence Determination
The TENS and EMS Stimulator, TENS Stimulator has the same intended use, and technological characteristics with the predicate device (K113010). A series of tests were performed and demonstrated substantial equivalence between the subject and the predicate device. Differences between the devices cited in this section do not raise any new issues of substantial equivalence.
| Item | Subject device | Predicate device | Substantially<br>equivalence |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Proprietary Name | TENS and EMS Stimulator, TENS<br>Stimulator | FOES 101 (ED401) TENS and EMS<br>Stimulator, FOES 102 (ED402)<br>TENS Stimulator, FOES 103<br>(ED403) EMS Stimulator | - |
| 510(k) No. | K183074 | K113010 | - |
| Model number | AK-10M, AK3-20,<br>AK3-25, AK3-50 | FOES101 (ED401) | - |
| Manufacturer | ASTEK Technology Ltd. | Famidoc Technology Co., Ltd | - |
| Prescription or OTC | Prescription | Prescription | Same |
| Regulation Number | 890.5850 | 890.5850 | Same |
| Product code | IPF, GZJ | IPF, GZJ | Same |
| Intended Use | TENS Stimulator (Model No.: AK-<br>10M)<br>TENS Stimulator provides 5 types TENS<br>output modes (P1-P5)<br>For TENS mode<br>(1) Symptomatic relief of chronic<br>intractable pain, (2) Post traumatic pain,<br>(3) Post-surgical pain<br><br>TENS and EMS Stimulator (Model | FDES 101 (ED401) TENS and EMS<br>Stimulator<br>For TENS mode<br>1. Symptomatic relief of chronic<br>intractable pain<br>2. Post traumatic pain<br>3. Post-surgical pain<br>For EMS mode<br>1. Relaxation of muscle spasm.<br>2. Increase of local blood flow | Same |
| Item | Subject device | Predicate device | Substantially<br>equivalence |
| | No.: AK3-20, AK3-25)<br>TENS and EMS Stimulator provides 8<br>types output modes (P1-P8). TENS/EMS<br>output modes (P1-P6&P8) and TENS<br>output modes (P7)<br>For TENS mode<br>(1) Symptomatic relief of chronic<br>intractable pain, (2) Post traumatic pain,<br>(3) Post-surgical pain<br>For EMS mode<br>(1) Relaxation of Muscle spasm, (2)<br>Increase of local blood flow circulation,<br>(3) Prevention or retardation of disuse<br>atrophy, (4) Muscle re-education, (5)<br>Maintaining or increasing range of<br>motion, (6) Immediate postsurgical<br>stimulation of muscles to prevent venous<br>thrombosis | circulation<br>3. Prevention or retardation of disuse<br>atrophy<br>4. Muscle re-education.<br>5. Maintaining or increasing range of<br>motion<br>6. Immediate post-surgical<br>stimulation of calf muscles to<br>prevent venous thrombosis | |
| | TENS and EMS Stimulator (Model<br>No.: AK3-50)<br>TENS and EMS Stimulator provides 10<br>types output modes (P0-P9). TENS output<br>modes (P0-P4) and EMS output modes<br>(P5-P9)<br>For TENS mode<br>(1) Symptomatic relief of chronic<br>intractable pain, (2) Post traumatic pain,<br>(3) Post-surgical pain<br>For EMS mode | | |
| Item | Subject device | Predicate device | Substantially<br>equivalence |
| | (1) Relaxation of Muscle spasm, (2)<br>Increase of local blood flow circulation,<br>(3) Prevention or retardation of disuse<br>atrophy, (4) Muscle re-education, (5)<br>Maintaining or increasing range of<br>motion, (6) Immediate postsurgical<br>stimulation of muscles to prevent venous<br>thrombosis | | |
| Using Environment | Physiotherapy clinics | Physiotherapy clinics | Same |
| Target population | Patients who need physiotherapy<br>treatment | Patients who need physiotherapy<br>treatment | Same |
| | | | |
| Treatment area | Neck / Shoulders, Waist/ Abdomen,<br>Arms and Hands, Legs and Feet | Any area (Except those treatment area<br>which been described in the user manual<br>can't use), such as hand, arm, chest,<br>waist, buttock, thigh, calf, back and low<br>back etc. | Same |
| | | | |
| | | | |
| | | | |
| Program | Model no.: AK-10M<br>- Mode: TENS<br>- Consisting of a monophasic waveform<br>with a different range of output<br>voltages, pulse durations, frequencies | - Not publicly available | Similar |
| | Model no.:AK3-20 | | |
| | - Mode: TENS or TENS/EMS | | |
| | - Consisting of a biphasic waveform<br>with a different range of output<br>voltages, pulse durations, frequencies,<br>etc. | | |
| | Model no.:AK3-25 | | |
| | - Mode: TENS or TENS/EMS | | |
| | - Consisting of a biphasic waveform | | |
| | | | |
| Item | Subject device | Predicate device | Substantially<br>equivalence |
| | with a different range of output<br>voltages, pulse durations, frequencies,<br>etc.<br><br>Model no.: AK3-50<br>- Mode: TENS or TENS/EMS<br>- Consisting of a biphasic waveform<br>with a different range of output<br>voltages, pulse durations, frequencies,<br>etc. | | |
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## Basic Unit Characteristics
| Item | Subject Device | | | | Predicate device | Substantially<br>equivalence | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|------------------------------------------|------------------------------------------|------------------------------------------|---------------------------------------|------------------------------|-----------|
| Model | AK-10M | AK3-20 | AK3-25 | AK3-50 | FOES101 (ED401) | - | |
| Type of use | Prescription Use | | | | Prescription Use | Same | |
| Power source | DC 3V<br>1xCR2032<br>battery | DC 3V<br>1xCR2032<br>battery | DC 3V<br>1xCR2032<br>battery | DC 6V 4xAA<br>batteries | DC 6V 4xAAA<br>batteries | Different | |
| Method of Line Current Isolation | N/A | N/A | N/A | N/A | N/A | Same | |
| Patient Leakage Current | | | | | | | |
| Normal condition | 0.1μA | 0.1μA | 0.1μA | 0.1μA | 3.0 μΑ | Different | |
| Single fault condition | N/A | N/A | N/A | N/A | 5.8 μΑ | | |
| Note: Although the “Power Source” and “Patient Leakage Current” of subject device are little different from the predicate devices, they all comply with IEC | | | | | | | |
| 60601-1 requirements. So the slight differences will not affect the safety and effectiveness of subject device. | | | | | | | |
| Number of Output Modes | | | | | | | |
| TENS | 5 | 1 | 1 | 5 | 15 | | |
| EMS | N/A | N/A | N/A | N/A | 15 | Similar | |
| TENS/EMS | N/A | 7 | 7 | 5 | N/A | | |
| Number of output channels | 1 | 1 | 2 | 4 | 2 | Different | |
| Synchronous or Alternating | Synchronous and | Synchronous and | Synchronous and | Synchronous and | Synchronous and | Same | |
| Method of Channel Isolation | Alternating | Alternating | Alternating | Alternating | Alternating | Same | |
| Item | Subject Device | | | | Predicate device | Substantially<br>equivalence | |
| Model | AK-10M | AK3-20 | AK3-25 | AK3-50 | FOES101 (ED401) | - | |
| | By electrical<br>circuit and<br>software | By electrical<br>circuit and<br>software | By electrical<br>circuit and<br>software | By electrical<br>circuit and<br>software | By electrical circuit and<br>software | | |
| Regulated Current or Regulated<br>Voltage? | Regulated<br>Voltage | Regulated<br>Voltage | Regulated<br>Voltage | Regulated<br>Voltage | Not publicly available | Different | |
| Software, Firmware, Microprocessor<br>control | Yes | Yes | Yes | Yes | Yes | Same | |
| Automatic Overload Trip? | N/A | N/A | N/A | N/A | Yes | Different | |
| Automatic No-Load Trip? | N/A | Yes | Yes | N/A | Yes | Different | |
| Automatic Shut Off? | Yes | Yes | Yes | Yes | Yes | Same | |
| Patient Override Control? | N/A | N/A | N/A | N/A | N/A | Same | |
| Indicator Display | | | | | | | |
| - On/Off Status | Yes | Yes | Yes | Yes | Yes | Same | |
| - Low Battery | N/A | N/A | N/A | Yes | Yes | Different | |
| - Voltage/Current Level | Yes | Yes | Yes | Yes | Yes | Same | |
| Timer range | 15 minutes | 15 minutes | 15 minutes | 10-30 minutes | 0-60 minutes | Different | |
| Compliance with Voluntary<br>Standards | IEC60601-1,<br>IEC60601-1-2, | IEC60601-1,<br>IEC60601-1-2, | IEC60601-1,<br>IEC60601-1-2, | IEC60601-1,<br>IEC60601-1-2, | IEC60601-1,<br>IEC60601-1-2, | Same | |
| Item | Subject Device | | | | Predicate device | Substantially<br>equivalence | |
| Model | AK-10M | AK3-20 | AK3-25 | AK3-50 | FOES101 (ED401) | | |
| | IEC60601-2-10,<br>ISO10993-1 | IEC60601-2-10,<br>ISO10993-1 | IEC60601-2-10,<br>ISO10993-1 | IEC60601-2-10,<br>ISO10993-1 | IEC60601-2-10,<br>ISO10993-1 | | |
| Compliance with 21 CFR898? | Yes | Yes | Yes | Yes | Not publicly available | Same | |
| Weight | 15.5 g | 80 g | 106 g | 282 g | 0.35 lbs. | Different | |
| Dimensions [W×H×D] | 54.8×35.6×10.8 | 70×69×44 | 70×70×70 mm | 137×96×41 | 76×129.7×35.1 mm | Different | |
| Housing materials and construction | ABS | PMMA, ABS | PMMA and ABS | ABS | ABS | Same | |
| Note: Although the "Number of Output Modes", "Number of Output Channels", "Automatic Overload Trip", "Automatic No-Load Trip", "Indicator Display",<br>"Timer Range", "Weight" and "Dimensions" of subject device are different from that of the predicate devices, they all comply with IEC 60601-1, IEC60601-<br>1-2, IEC 60601-2-10 and ISO10993-1 requirements. Hence, differences will not affect the safety and effectiveness of subject device. | | | | | | | |
| Waveform | Biphasic wave | Biphasic wave | Biphasic wave | Biphasic wave | Biphasic wave | Different | |
| Shape (e.g., rectangular, spike,<br>rectified sinusoidal) | Square | Square | Square | Square | Square | Different | |
| Maximum Output<br>Voltage | @500Ω | 73.19 Vpp | 66.4 Vpp | 33.4 Vpp | 73.19 Vpp | Not publicly<br>available | Different |
| | @2KΩ | 94.22 Vpp | 107.6 Vpp | 66 Vpp | 52 Vpp | Not publicly<br>available | |
| | @10KΩ | 113.1 Vpp | 129.6 Vpp | 117.2 Vpp | 52 Vpp | Not publicly<br>available | |
| Maximum Output<br>Current | @500Ω | 146.38 mA | 132.8 mA | 66.8 mA | 96 mA | Not publicly<br>available | Different |
| | @2KΩ | 47.11 mA | 53.8 mA | 33 mA | 26 mA | Not publicly<br>available | |
| | @10KΩ | 11.31 mA | 12.96 mA | 11.72 mA | 5.2 mA | Not publicly<br>available | |
| | Subject Device | | | | Predicate device | Substantially<br>equivalence | |
| Item…
