(432 days)
Not Found
No
The description details a standard TENS/EMS device with pre-set modes and adjustable parameters controlled by physical buttons. There is no mention of adaptive algorithms, learning capabilities, or any technology that would typically be associated with AI/ML.
Yes.
The device description clearly states its intended use for symptomatic relief of chronic intractable pain, post-traumatic pain, and post-surgical pain (TENS mode), and for muscle relaxation, blood flow circulation, prevention of disuse atrophy, muscle re-education, and increasing range of motion (EMS mode). These are all therapeutic applications.
No
Explanation: The document describes the device as a TENS and EMS stimulator used for pain relief, muscle relaxation, blood flow circulation, and muscle re-education. It does not mention any function related to diagnosing a condition or disease.
No
The device description clearly outlines physical hardware components such as a molded plastic case, LCD display, keypad, and battery storage compartment, which are integral to the device's function. While software validation is mentioned, it is part of the overall device testing, not indicative of 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 clearly states that the device is for "Symptomatic relief of chronic intractable pain," "Post traumatic pain," "Post-surgical pain," and various muscle-related conditions. These are all therapeutic applications, not diagnostic ones.
- Device Description: The description details how the device works by sending electrical current to nerves and muscles via electrodes applied to the skin. This is a physical intervention, not a test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
IPF, GZJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
TENS Stimulator (Model No.: AK-10M): "Neck / Shoulders, Waist/ Abdomen, Arms and Hands, Legs and Feet"
TENS and EMS Stimulator (Models AK3-20, AK3-25, AK3-50): "Neck / Shoulders, Waist/ Abdomen, Arms and Hands, Legs and Feet"
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physiotherapy clinics
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)
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.
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.
Not Found
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
§ 890.5850 Powered muscle stimulator.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below.
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.
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/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
2
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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3
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 |
| 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 |
| Stimulator, FDES 102 (ED402) TENS | |
| Stimulator, FDES 103 (ED403) EMS | |
| Stimulator | |
| Manufacturer: | Famidoc Technology Co., Ltd |
| Regulation number: | 890.5850 |
| Device Class: | II |
| Primary Product Code | IPF |
| Subsequent Product Code | GZJ |
4
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
5
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
equivalence |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Proprietary Name | TENS and EMS Stimulator, TENS
Stimulator | FOES 101 (ED401) TENS and EMS
Stimulator, FOES 102 (ED402)
TENS Stimulator, FOES 103
(ED403) EMS Stimulator | - |
| 510(k) No. | K183074 | K113010 | - |
| Model number | AK-10M, AK3-20,
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-
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 | FDES 101 (ED401) TENS and EMS
Stimulator
For TENS mode
- Symptomatic relief of chronic
intractable pain - Post traumatic pain
- Post-surgical pain
For EMS mode - Relaxation of muscle spasm.
- Increase of local blood flow | Same |
| Item | Subject device | Predicate device | Substantially
equivalence |
| | No.: AK3-20, 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 | circulation - Prevention or retardation of disuse
atrophy - Muscle re-education.
- Maintaining or increasing range of
motion - Immediate post-surgical
stimulation of calf 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 | | |
| Item | Subject device | Predicate device | Substantially
equivalence |
| | (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 | | |
| Using Environment | Physiotherapy clinics | Physiotherapy clinics | Same |
| Target population | Patients who need physiotherapy
treatment | Patients who need physiotherapy
treatment | Same |
| | | | |
| Treatment area | Neck / Shoulders, Waist/ Abdomen,
Arms and Hands, Legs and Feet | Any area (Except those treatment area
which been described in the user manual
can't use), such as hand, arm, chest,
waist, buttock, thigh, calf, back and low
back etc. | Same |
| | | | |
| | | | |
| | | | |
| Program | Model no.: AK-10M
- Mode: TENS
- Consisting of a monophasic waveform
with a different range of output
voltages, pulse durations, frequencies | - Not publicly available | Similar |
| | Model no.:AK3-20 | | |
| | - Mode: TENS or TENS/EMS | | |
| | - Consisting of a biphasic waveform
with a different range of output
voltages, pulse durations, frequencies,
etc. | | |
| | Model no.:AK3-25 | | |
| | - Mode: TENS or TENS/EMS | | |
| | - Consisting of a biphasic waveform | | |
| | | | |
| Item | Subject device | Predicate device | Substantially
equivalence |
| | with a different range of output
voltages, pulse durations, frequencies,
etc.
Model no.: AK3-50
- Mode: TENS or TENS/EMS
- Consisting of a biphasic waveform
with a different range of output
voltages, pulse durations, frequencies,
etc. | | |
7
8
9
10
Basic Unit Characteristics
| Item | Subject Device | | | | Predicate device | Substantially
equivalence | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|------------------------------------------|------------------------------------------|------------------------------------------|---------------------------------------|------------------------------|-----------|
| Model | AK-10M | AK3-20 | AK3-25 | AK3-50 | FOES101 (ED401) | - | |
| Type of use | Prescription Use | | | | Prescription Use | Same | |
| Power source | DC 3V
1xCR2032
battery | DC 3V
1xCR2032
battery | DC 3V
1xCR2032
battery | DC 6V 4xAA
batteries | DC 6V 4xAAA
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
equivalence | |
| Model | AK-10M | AK3-20 | AK3-25 | AK3-50 | FOES101 (ED401) | - | |
| | By electrical
circuit and
software | By electrical
circuit and
software | By electrical
circuit and
software | By electrical
circuit and
software | By electrical circuit and
software | | |
| Regulated Current or Regulated
Voltage? | Regulated
Voltage | Regulated
Voltage | Regulated
Voltage | Regulated
Voltage | Not publicly available | Different | |
| Software, Firmware, Microprocessor
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
Standards | IEC60601-1,
IEC60601-1-2, | IEC60601-1,
IEC60601-1-2, | IEC60601-1,
IEC60601-1-2, | IEC60601-1,
IEC60601-1-2, | IEC60601-1,
IEC60601-1-2, | Same | |
| Item | Subject Device | | | | Predicate device | Substantially
equivalence | |
| Model | AK-10M | AK3-20 | AK3-25 | AK3-50 | FOES101 (ED401) | | |
| | IEC60601-2-10,
ISO10993-1 | IEC60601-2-10,
ISO10993-1 | IEC60601-2-10,
ISO10993-1 | IEC60601-2-10,
ISO10993-1 | IEC60601-2-10,
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",
"Timer Range", "Weight" and "Dimensions" of subject device are different from that of the predicate devices, they all comply with IEC 60601-1, IEC60601-
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,
rectified sinusoidal) | Square | Square | Square | Square | Square | Different | |
| Maximum Output
Voltage | @500Ω | 73.19 Vpp | 66.4 Vpp | 33.4 Vpp | 73.19 Vpp | Not publicly
available | Different |
| | @2KΩ | 94.22 Vpp | 107.6 Vpp | 66 Vpp | 52 Vpp | Not publicly
available | |
| | @10KΩ | 113.1 Vpp | 129.6 Vpp | 117.2 Vpp | 52 Vpp | Not publicly
available | |
| Maximum Output
Current | @500Ω | 146.38 mA | 132.8 mA | 66.8 mA | 96 mA | Not publicly
available | Different |
| | @2KΩ | 47.11 mA | 53.8 mA | 33 mA | 26 mA | Not publicly
available | |
| | @10KΩ | 11.31 mA | 12.96 mA | 11.72 mA | 5.2 mA | Not publicly
available | |
| | Subject Device | | | | Predicate device | Substantially
equivalence | |
| Item | AK-10M | AK3-20 | AK3-25 | AK3-50 | FOES101 (ED401) | | |
| Model | AK-10M | AK3-20 | AK3-25 | AK3-50 | FOES101 (ED401) | - | |
| Pulse Width | 175 μS | 100 μS | 100 μS | 125 μS | 50-300μS | Different | |
| Frequency | 2-120Hz | 3-50 Hz | 3-50 Hz | 1-50 Hz | 0.5-150Hz | Different | |
| For interferential modes only
- Beat Frequency (Hz) | N/A | N/A | N/A | N/A | Not publicly available | Same | |
| For multiphasic waveforms only | | | | | Not publicly available | | |
| - Symmetrical phases | Yes | N/A | N/A | N/A | Not publicly available | Same | |
| - Phase Duration | 350 μs | 200 μs | 200 μs | 250 μs | Not publicly available | Different | |
| Net Charge (@500Ω) | 24.9μC | 22.8 μC | 22.8 μC | 23.5 μC | Not publicly available | Different | |
| Maximum Phase Charge (@500Ω) | 24.9μC | 22.8 μC | 22.8 μC | 23.5 μC | Not publicly available | Different | |
| Maximum Current Density, @500Ω |