(432 days)
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
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.
The provided text describes a 510(k) summary for a TENS and EMS Stimulator. The document states that no clinical test data was used to support the decision of substantial equivalence. Instead, the device's acceptance criteria are demonstrated through non-clinical testing, ensuring safety and performance.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" and "reported device performance" in the typical sense of a clinical or analytical study. Instead, it details that the device underwent a "series of safety and performance tests" to demonstrate substantial equivalence to a predicate device. The implied acceptance criteria for each test are that the device meets the requirements of relevant electrical safety and biocompatibility standards.
The "reported device performance" is implicitly that the device passed these tests and complies with the standards. The table titled "Basic Unit Characteristics" compares various technical specifications between the subject device (multiple models) and the predicate device, noting similarities and differences. The conclusion drawn is that despite some differences in specifications, all tested aspects comply with relevant standards.
Here's a summary of the non-clinical tests and the general outcome:
| Acceptance Criteria Category | Specific Tests Conducted | Reported Device Performance |
|---|---|---|
| Safety & Performance | Shelf life test | Meets requirements of pre-defined acceptance criteria |
| Software validation | Meets requirements of pre-defined acceptance criteria | |
| EMC and Electrical Safety test | Meets requirements of pre-defined acceptance criteria | |
| Performance test | Meets requirements of pre-defined acceptance criteria | |
| Regulatory Compliance | Compliance with IEC60601-1, IEC60601-1-2, IEC60601-2-10, ISO10993-1 | All models comply with these standards. |
| Compliance with 21 CFR898 | All models comply with 21 CFR898. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size for the test set in terms of the number of devices tested for non-clinical studies. It refers to a "series of safety and performance tests" conducted on "the subject device, TENS and EMS Stimulator, TENS Stimulator" (page 5). Typically, for non-clinical hardware testing, a small number of units (e.g., 3-5) are tested to demonstrate compliance.
The data provenance is from ASTEK Technology Ltd. in Taiwan, which submitted the 510(k). The tests are non-clinical (laboratory studies) and therefore are prospective in nature for the purpose of demonstrating compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This question is not applicable. The ground truth for non-clinical safety and performance tests is established by adherence to recognized national and international electrical safety, EMC, and biocompatibility standards (e.g., IEC 60601-1, ISO 10993-1). These standards define objective pass/fail criteria. There isn't a "ground truth" derived from expert consensus in the way there would be for image analysis or diagnostic AI. The tests are purely engineering and regulatory compliance assessments.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods are typically relevant for clinical studies or studies involving subjective interpretation (e.g., by multiple human readers). For non-clinical performance and safety tests, the results are objectively measured against predefined criteria in the standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was done. The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence." This device is not an AI diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical TENS and EMS stimulator, not a standalone algorithm. While it has software, the validation is for the device's overall operation and safety, not for an AI algorithm's standalone diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
As this is a non-clinical submission, the "ground truth" for demonstrating the device meets acceptance criteria is compliance with established international and national standards (e.g., IEC 60601-1 for electrical safety, ISO 10993-1 for biocompatibility). The tests measure physical and electrical properties against the limits and requirements specified in these standards.
8. The sample size for the training set
This question is not applicable. There is no mention of a "training set" as this is a non-AI medical device submission based on non-clinical performance and safety testing against predicate devices and standards.
9. How the ground truth for the training set was established
This question is not applicable, as there is no training set mentioned or implied for this device and its submission.
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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.
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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 City71741, 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 EMSStimulator, FDES 102 (ED402) TENSStimulator, FDES 103 (ED403) EMSStimulator |
| 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 | Substantiallyequivalence |
|---|---|---|---|
| Proprietary Name | TENS and EMS Stimulator, TENSStimulator | FOES 101 (ED401) TENS and EMSStimulator, 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 TENSoutput modes (P1-P5)For TENS mode(1) Symptomatic relief of chronicintractable pain, (2) Post traumatic pain,(3) Post-surgical painTENS and EMS Stimulator (Model | FDES 101 (ED401) TENS and EMSStimulatorFor TENS mode1. Symptomatic relief of chronicintractable pain2. Post traumatic pain3. Post-surgical painFor EMS mode1. Relaxation of muscle spasm.2. Increase of local blood flow | Same |
| Item | Subject device | Predicate device | Substantiallyequivalence |
| No.: AK3-20, AK3-25)TENS and EMS Stimulator provides 8types output modes (P1-P8). TENS/EMSoutput modes (P1-P6&P8) and TENSoutput modes (P7)For TENS mode(1) Symptomatic relief of chronicintractable pain, (2) Post traumatic pain,(3) Post-surgical painFor EMS mode(1) Relaxation of Muscle spasm, (2)Increase of local blood flow circulation,(3) Prevention or retardation of disuseatrophy, (4) Muscle re-education, (5)Maintaining or increasing range ofmotion, (6) Immediate postsurgicalstimulation of muscles to prevent venousthrombosis | circulation3. Prevention or retardation of disuseatrophy4. Muscle re-education.5. Maintaining or increasing range ofmotion6. Immediate post-surgicalstimulation of calf muscles toprevent venous thrombosis | ||
| TENS and EMS Stimulator (ModelNo.: AK3-50)TENS and EMS Stimulator provides 10types output modes (P0-P9). TENS outputmodes (P0-P4) and EMS output modes(P5-P9)For TENS mode(1) Symptomatic relief of chronicintractable pain, (2) Post traumatic pain,(3) Post-surgical painFor EMS mode | |||
| Item | Subject device | Predicate device | Substantiallyequivalence |
| (1) Relaxation of Muscle spasm, (2)Increase of local blood flow circulation,(3) Prevention or retardation of disuseatrophy, (4) Muscle re-education, (5)Maintaining or increasing range ofmotion, (6) Immediate postsurgicalstimulation of muscles to prevent venousthrombosis | |||
| Using Environment | Physiotherapy clinics | Physiotherapy clinics | Same |
| Target population | Patients who need physiotherapytreatment | Patients who need physiotherapytreatment | Same |
| Treatment area | Neck / Shoulders, Waist/ Abdomen,Arms and Hands, Legs and Feet | Any area (Except those treatment areawhich been described in the user manualcan't use), such as hand, arm, chest,waist, buttock, thigh, calf, back and lowback etc. | Same |
| Program | Model no.: AK-10M- Mode: TENS- Consisting of a monophasic waveformwith a different range of outputvoltages, pulse durations, frequencies | - Not publicly available | Similar |
| Model no.:AK3-20 | |||
| - Mode: TENS or TENS/EMS | |||
| - Consisting of a biphasic waveformwith a different range of outputvoltages, pulse durations, frequencies,etc. | |||
| Model no.:AK3-25 | |||
| - Mode: TENS or TENS/EMS | |||
| - Consisting of a biphasic waveform | |||
| Item | Subject device | Predicate device | Substantiallyequivalence |
| with a different range of outputvoltages, pulse durations, frequencies,etc.Model no.: AK3-50- Mode: TENS or TENS/EMS- Consisting of a biphasic waveformwith a different range of outputvoltages, pulse durations, frequencies,etc. |
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Basic Unit Characteristics
| Item | Subject Device | Predicate device | Substantiallyequivalence | ||||
|---|---|---|---|---|---|---|---|
| Model | AK-10M | AK3-20 | AK3-25 | AK3-50 | FOES101 (ED401) | - | |
| Type of use | Prescription Use | Prescription Use | Same | ||||
| Power source | DC 3V1xCR2032battery | DC 3V1xCR2032battery | DC 3V1xCR2032battery | DC 6V 4xAAbatteries | DC 6V 4xAAAbatteries | 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 | Substantiallyequivalence | ||||
| Model | AK-10M | AK3-20 | AK3-25 | AK3-50 | FOES101 (ED401) | - | |
| By electricalcircuit andsoftware | By electricalcircuit andsoftware | By electricalcircuit andsoftware | By electricalcircuit andsoftware | By electrical circuit andsoftware | |||
| Regulated Current or RegulatedVoltage? | RegulatedVoltage | RegulatedVoltage | RegulatedVoltage | RegulatedVoltage | Not publicly available | Different | |
| Software, Firmware, Microprocessorcontrol | 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 VoluntaryStandards | 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 | Substantiallyequivalence | ||||
| 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 OutputVoltage | @500Ω | 73.19 Vpp | 66.4 Vpp | 33.4 Vpp | 73.19 Vpp | Not publiclyavailable | Different |
| @2KΩ | 94.22 Vpp | 107.6 Vpp | 66 Vpp | 52 Vpp | Not publiclyavailable | ||
| @10KΩ | 113.1 Vpp | 129.6 Vpp | 117.2 Vpp | 52 Vpp | Not publiclyavailable | ||
| Maximum OutputCurrent | @500Ω | 146.38 mA | 132.8 mA | 66.8 mA | 96 mA | Not publiclyavailable | Different |
| @2KΩ | 47.11 mA | 53.8 mA | 33 mA | 26 mA | Not publiclyavailable | ||
| @10KΩ | 11.31 mA | 12.96 mA | 11.72 mA | 5.2 mA | Not publiclyavailable | ||
| Subject Device | Predicate device | Substantiallyequivalence | |||||
| 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 | < 2 mA/cm² | 0.204mA/cm² | 0.32 mA/cm² | 0.216 mA/cm² | Not publicly available | Different | |
| Maximum Power Density, (W/cm²)r.m.s., @500Ω | 0.049 | 0.0446 | 0.013 | 0.023 | Not publicly available | Different | |
| Burst Mode | Not publicly available | ||||||
| - Pulses per burst | N/A | N/A | N/A | N/A | Not publicly available | ||
| - Bursts per second | N/A | N/A | N/A | N/A | Not publicly available | Different | |
| - Burst duration (seconds) | N/A | N/A | N/A | N/A | Not publicly available | ||
| - Duty Cycle | N/A | N/A | N/A | N/A | Not publicly available | ||
| ON Time (seconds) | N/A | N/A | N/A | N/A | Not publicly available | Different | |
| Item | Subject Device | Predicate device | Substantiallyequivalence | ||||
| Model | AK-10M | AK3-20 | AK3-25 | AK3-50 | FOES101 (ED401) | - | |
| OFF Time (seconds) | N/A | N/A | N/A | N/A | Not publicly available | Different | |
| Electrode area | N/A | N/A | N/A | N/A | Not publicly available | Different | |
| Note: | |||||||
| Due to our design consideration, the "Maximum Output Voltage", "Maximum Output Current", "Pulse Width", "Frequency", "multi-program waveforms", | |||||||
| "Net charge", "Max. Phase Charge", "Max. Current Density", "Max. Average Power Density", "Burst Mode", "ON/OFF time" and "Electrode area" are not | |||||||
| all the same as that of the predicate. However, both of comply with IEC 60601-1, IEC60601-1-2, IEC 60601-2-10 and ISO10993-1 requirements. In spite of | |||||||
| these differences, the subject device passed the safety and performance tests. So the differences will not affect the safety and effectiveness of subject device, |
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and not affect the substantial equivalence between these devices.
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5.10 Similarity and Differences
The subject device has same intended use and similar technological characteristics as predicate device. Difference between the subject device and predicate device are such as patient leakage current, number of output modes, number of output channels, regulated current or regulated voltage, timer range, weight, dimensions and output Specifications. Although there are some differences between subject and predicate devices, the subject device has passed a series of electrical safety and performance tests. And thus, we believe that differences between the devices cited in this section do not raise any new issues of substantial equivalence. The subject device is substantially equivalent to the predicate device in safety and performance claims.
5.11 Conclusion
After analyzing non-clinical laboratory studies and safety testing data, it can be concluded that TENS and EMS Stimulator, TENS Stimulator is substantially equivalent to the predicate device.
§ 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).