(90 days)
No
The document describes a standard TENS device with adjustable intensity levels and pre-set treatment sessions. There is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is described as providing "temporary relief of pain associated with sore and aching muscles," which is a therapeutic effect. It uses Transcutaneous Electrical Nerve Stimulation (TENS), a recognized non-pharmacological method of pain relief.
No
Explanation: The device is a TENS unit designed for temporary pain relief by stimulating nerves through the skin. Its intended use and description focus on providing therapy for pain, not on diagnosing medical conditions.
No
The device description explicitly states it is a "self-adhesive TENS" powered by a battery and includes physical components like electrodes and a storage rack. It also mentions hardware-related testing like EMC and electrical safety.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for temporary relief of pain associated with sore and aching muscles. This is a therapeutic use, not a diagnostic one.
- Device Description: The device is a TENS unit, which delivers electrical stimulation to the body. This is a physical therapy modality, not a method for analyzing samples from the body.
- Mechanism of Action: TENS works by stimulating nerves through the skin to relieve pain. This is a direct interaction with the body, not an analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of detecting diseases, conditions, or states of health.
In summary, the POCKET TENS (EP-300) is a therapeutic device used for pain relief, not a diagnostic device used for analyzing samples from the body.
N/A
Intended Use / Indications for Use
POCKET TENS (EP-300) which is home used device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
Product codes (comma separated list FDA assigned to the subject device)
NUH
Device Description
This device powered by CR2032 Lithium 3V battery is a self-adhesive TENS with 15 adjustable intensity levels falling into the electro-stimulation device category. It includes pocket storage rack for electrodes and TENS device. It designed for shoulder, back, upper extremities (arm) and lower extremities (leg) pain relief. Users only need to place the electrode gel pads on the sides of pain point and then power on the device, and adjust the pulse intensity to a proper level to start a 20 minute treatment session. For optimum result, rest 30 minutes between sessions.
TENS refers to the electrical stimulation of nerves through the skin which is a non-pharmacological method of pain relief. Any symptoms that could be relieved using TENS must be checked by patient's general practitioner who will also give patient instruction on how to carry out a TENS self-treatment regime.
This device is only compatible with the 75 mm x 48 mm gel pads which are the OTC medical device cleared by FDA under K083302 or K180865, and come with the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, back, upper extremities (arm) and lower extremities (leg)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home used device
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 including Shelf life, Gel pad lifetime, Biocompatibility (In Vitro Cytotoxicity Test, Skin Sensitization Study, Skin Irritation Study), Software validation (IEC 62304:2006+A1:2015, ISO 14971:2019, ISO TR 24971:2020), EMC and electrical safety (IEC 60601-1-2:2014+A1:2020, IEC TR 60601-4-2:2016, ANSI/AAMI ES60601-1:2005+A2:2021, IEC 60601-1-11:2015+A1:2020, IEC 60601-2-10:2012+A1:2016, IEC 60086-4:2019), Performance verification (Guidance Document for Powered Muscle Stimulator 510(K)s.), Output waveform validation, Impedance validation, and Usability (IEC 60601-1-6:2010+A2:2020, ANSI/AAMI/IEC 62366-1:2015+A1:2020) were conducted. All test results demonstrate the subject device meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate devices. No clinical test data was used.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 17, 2024
Hivox Biotek Inc. Leslie Peng Senior Product Manager 5F., No. 123, Xingde Rd., Sanchong District New Taipei City, 24158 Taiwan
Re: K242815
Trade/Device Name: Pocket Tens (EP-300) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH Dated: September 6, 2024 Received: September 18, 2024
Dear Leslie Peng:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a
change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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).
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Sincerely,
Robert Kang -S
for Pamela Scott, MS Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
POCKET TENS (EP-300)
Indications for Use (Describe)
POCKET TENS (EP-300) which is home used device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
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)
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510(k) SUMMARY
1. Type of Submission Traditional
-
- Date of Summary December 16, 2024
- HIVOX BIOTEK INC. 3. Submitter Address: 5F., No. 123, Xingde Rd., Sanchong District, New Taipei City 241, Taiwan, R.O.C. Phone: +886-2-8511-2668 Fax: +886-2-8511-2669 Contact: Leslie Peng (leslie.peng@hivox-biotek.com)
4. Identification of the Subject Device
| Proprietary name: | POCKET TENS |
|---|---|
| Model: | EP-300 |
| Regulation number: | 21 CFR 882.5890 |
| Regulation description: | Transcutaneous electrical nerve stimulator for pain relief |
| Product code: | NUH |
| Device class: | II |
5. Identification of the Predicate Device #1
| 510(k) number: | K171803 |
|---|---|
| Manufacturer: | HIVOX BIOTEK INC. |
| Proprietary name: | HIVOX OTC Electrical Stimulator |
| Model: | SEM44-1 |
| Primary Regulation | |
| number: | 21 CFR 882.5890 |
| Primary Regulation | |
| description: | Transcutaneous electrical nerve stimulator for pain relief |
| Product code: | NUH, NGX |
| Device class: | II |
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6. Identification of the Predicate Device #2
| 510(k) number: | K140650 |
|---|---|
| Manufacturer: | HIVOX BIOTEK INC. |
| Proprietary name: | HIVOX Electric Stimulator OTC TENS, Rapid Relief™ |
| Pennypad PP-904 | |
| Model: | PP-904 |
| Regulation number: | 21 CFR 882.5890 |
| Regulation description: | Transcutaneous electrical nerve stimulator for pain relief |
| Product code: | NUH |
| Device class: | II |
7. Device Description
This device powered by CR2032 Lithium 3V battery is a self-adhesive TENS with 15 adjustable intensity levels falling into the electro-stimulation device category. It includes pocket storage rack for electrodes and TENS device. It designed for shoulder, back, upper extremities (arm) and lower extremities (leg) pain relief. Users only need to place the electrode gel pads on the sides of pain point and then power on the device, and adjust the pulse intensity to a proper level to start a 20 minute treatment session. For optimum result, rest 30 minutes between sessions.
TENS refers to the electrical stimulation of nerves through the skin which is a non-pharmacological method of pain relief. Any symptoms that could be relieved using TENS must be checked by patient's general practitioner who will also give patient instruction on how to carry out a TENS self-treatment regime.
This device is only compatible with the 75 mm x 48 mm gel pads which are the OTC medical device cleared by FDA under K083302 or K180865, and come with the device.
8. Intended Use / Indications for Use
POCKET TENS (EP-300) which is home used device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
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9. Substantial Equivalence Comparison
Refer to section 12 for complete comparison table.
10. Non-clinical Testing
A series of safety and performance tests, as follows, were conducted on the subject device in accordance with FDA recognized consensus standards and/or guidance:
- Shelf life
- Gel pad lifetime
- Biocompatibility
- Biological evaluation (ISO 10993-1:2018) -
- -In Vitro Cytotoxicity Test (ISO 10993-5:2009)
- Skin Sensitization Study (ISO 10993-10:2021, ISO 10993-10:2010) |
- -Skin Irritation Study (ISO 10993-23:2021, ISO 10993-10:2010)
- Software validation
- IEC 62304:2006+A1:2015 -
- -ISO 14971:2019
- ISO TR 24971:2020 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
- EMC and electrical safety ●
- -IEC 60601-1-2:2014+A1:2020
- -IEC TR 60601-4-2:2016
- ANSI/AAMI ES60601-1:2005+A2:2021 -
- IEC 60601-1-11:2015+A1:2020 -
- IEC 60601-2-10:2012+A1:2016 —
- -IEC 60086-4:2019
- Performance verification
- Guidance Document for Powered Muscle Stimulator 510(K)s. (June 9, -1999)
- Output waveform validation ●
- Impedance validation
- Usability
- IEC 60601-1-6:2010+A2:2020 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
- ANSI/AAMI/IEC 62366-1:2015+A1:2020 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
All the test results demonstrate the subject device, POCKET TENS (EP-300), meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate devices.
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11. Clinical Testing
No clinical test data was used to support the decision of substantial equivalence.
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12. Substantial Equivalence Comparison
The subject device, POCKET TENS (EP-300), was compared to the predicate devices in the table below:
| Comparison item | Subject device | Predicate device #1 | Predicate device #2 | Substantial
Equivalence Determination | |
|----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| 510(k) number | K242815 | K171803 | K140650 | | |
| Device name | POCKET TENS | HIVOX OTC Electrical
Stimulator | HIVOX Electric Stimulator OTC
TENS, Rapid Relief™ Pennypad
PP-904 | N/A | |
| Model | EP-300 | SEM44-1 | PP-904 | | |
| Manufacturer | HIVOX BIOTEK INC. | HIVOX BIOTEK INC. | HIVOX BIOTEK INC. | | |
| Intended Use | POCKET TENS (EP-300)
which is home used device
is designed to be used for
temporary relief of pain
associated with sore and
aching muscles in the
shoulder, back, upper
extremities (arm) and lower
extremities (leg) due to
strain from exercise or
normal household work | The device is designed to be
used for temporary relief of
pain associated with sore and
aching muscles in the shoulder,
waist, back, neck, upper
extremities (arm), lower
extremities (leg), abdomen and
bottom due to strain from
exercise or normal household
work activities. | The HIVOX Electric Stimulator
OTC TENS, Rapid Relief™
Pennypad PP-904, is indicated for
temporary relief of pain associated
with sore and aching muscles in
the upper and lower extremities
(arm and/or leg), and lower back
due to strain from exercise or
normal household and work
activities. | | |
| Comparison item | Subject device | Predicate device #1 | Predicate device #2 | Substantial
Equivalence Determination | |
| | activities. | | | | |
| FDA product code | NUH | NUH, NGX | NUH | All predicates have NUH product
code | |
| Prescription or OTC | OTC | OTC | OTC | Identical to predicate devices | |
| Basic unit characteristics | | | | | |
| Power source(s) | CR2032 Lithium 3V | 4.5V (batteries, 3x1.5V AAA) | CR2032 Lithium 3V | Identical to Predicate device #2 | |
| Function and design | Electrical stimulation | Electrical stimulation | Electrical stimulation | Identical to predicate devices | |
| Number of output modes | TENS:1 | TENS:15 | TENS:1 | Identical to Predicate device #2 | |
| Number of
output
channels | Synchronous
or
Alternating? | Single Channel | Two Channels
(Synchronous) | Single Channel | Identical to Predicate device #2 |
| | Method of
channel
isolation | N/A | By electrical circuit and software | N/A | Identical to Predicate device #2 |
| Regulated current or
regulated voltage? | Regulated voltage | Regulated voltage | Regulated voltage | Identical to predicate devices | |
| Software/Firmware/
Microprocessor Control? | Yes | Yes | Yes | Identical to predicate devices | |
| Automatic overload trip? | Yes | Yes | Yes | Identical to predicate devices | |
| Automatic no-load trip? | Yes | Yes | Yes | Identical to predicate devices | |
| Comparison item | Subject device | Predicate device #1 | Predicate device #2 | Substantial
Equivalence Determination | |
| Automatic shut off? | Yes | Yes | Yes | Identical to predicate devices | |
| Patient override control? | Yes | Yes | Yes | Identical to predicate devices | |
| Indicator
display | On/off
status? | No | Yes | No | Identical to Predicate device #2 |
| | Low battery? | No | Yes | No | Identical to Predicate device #2 |
| | Voltage/
current
level? | No | Yes | No | Identical to Predicate device #2 |
| Timer range (minutes) | 20 | 5-100 | 20 | Identical to Predicate device #2 | |
| Comparison item | Subject device | Predicate device #1 | Predicate device #2 | Substantial
Equivalence Determination | |
| Compliance with
voluntary standards? | ISO 10993-1:2018
ISO 10993-5:2009
ISO 10993-10:2010
ISO 10993-10:2021
ISO 10993-23:2021
IEC 62304:2006+A1:2015
ISO 14971:2019
ISO TR 24971:2020
IEC 60601-1-2:2014
+A1:2020
IEC TR 60601-4-2:2016
ANSI/AAMI ES60601-1:
2005+A2:2021
IEC 60601-1-11:2015
+A1:2020
IEC 60601-2-10:2012
+A1:2016
IEC 60086-4:2019
IEC 60601-1-6:2010
+A2:2020
ANSI/AAMI/IEC 62366-1:
2015+A1:2020 | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-10
ISO 10993-5/10 | IEC/EN 60601-1
IEC/EN 60601-1-2
IEC/EN 60601-2-10 | The subject device complies with
the latest standards. | |
| Compliance with 21 CFR | Yes | Yes | Yes | Identical to predicate devices | |
| Comparison item | | Subject device | Predicate device #1 | Predicate device #2 | Substantial
Equivalence Determination |
| 898? | | | | | |
| Weight | | Main device
(including a set of pad): 35.6 g
Gel pads (2 pieces): 9.4 g
Battery: 3.0 g | 89 g
(including belt clip, without
batteries),
123 g
(including belt clip and batteries) | 13.7 g (excluded battery) | The differences from weight would
not raise concern in safety or
effectiveness as predicate devices |
| Dimensions
[W × H × D] | | Approx.
Main device:
66.8 × 35.0 × 10.6 mm
Pad: 99.5 × 62.0 × 1.0 mm
Wire: 391.0 mm | Approx.
132 × 63 × 29.5 mm
(including belt clip) | Approx.
113 × 70 × 10 mm | The differences from dimension
would not raise concern in safety
or effectiveness as predicate
devices |
| Housing materials and
construction | | ABS plastic enclosure | ABS Plastic enclosure | ABS Plastic enclosure | Identical to predicate devices |
| Output specifications | | | | | |
| Waveform | | Biphasic, Symmetrical | Biphasic, Symmetrical | Monophasic with reversing polarity
each phase | Identical to Predicate device #1 |
| Shape | | Rectangular | Rectangular | Rectangular | Identical to predicate devices |
| Maximum
output | @ 500 Ω | 50V for both phases, peak of
25V for each phase | 100V peak-to-peak, 50V peak for
each phase | 30V peak monophasic | Refer to Section 13 for substantial
equivalence |
| Comparison item | Subject device | Predicate device #1 | Predicate device #2 | Substantial
Equivalence Determination | |
| voltage
(Vp-p, ±10%) | @ 2 kΩ
92
@ 10 kΩ
101 | 180
250 | 89.6
96 | | |
| Maximum
output
current
(mAp-p, ±10%) | @ 500 Ω
100mA peak-to-peak, 50mA peak
@ 2 kΩ
37.5
@ 10 kΩ
10.1 | 200
90
25 | 60mA peak
44.8
9.6 | Refer to Section 13 for substantial
equivalence | |
| Pulse Width (μs) | 50mA x 0.4mSec = 20 μC | 50-450 | 200 | Refer to Section 13 for substantial
equivalence | |
| Frequency (Hz) | 4, 6 and 50 | 1-150 | 2, 5 and 40 | Refer to Section 13 for substantial
equivalence | |
| Net charge
(μC per pulse @ 500Ω) | 0 | 0.001 | 0.2304 | Refer to Section 13 for substantial
equivalence | |
| Maximum phase charge
(μC @ 500Ω) | 20 | 0.045 = 45 μC | 60mA x 0.2mSec = 12 μC | Refer to Section 13 for substantial
equivalence | |
| Maximum average current
(mA @ 500Ω) | 3.46 | 13.5 | 2.303 | Refer to Section 13 for substantial
equivalence | |
| Electrode conductive
surface area (cm²) | $31.04 cm²×2 (=62.08 cm²)$ | $20.25 cm²x4 (=81cm²)$ | $20.366cm²x2 (=40.732 cm²)$ | Refer to Section 13 for substantial
equivalence | |
| Comparison item | Subject device | Predicate device #1 | Predicate device #2 | Substantial
Equivalence Determination | |
| Maximum current density
(mA/cm² @ 500Ω) | 1.61080 | 0.667 | 2.828 | Refer to Section 13 for substantial
equivalence | |
| Maximum power density
(W/cm² @ 500Ω) | 0.0801 | 0.0046 | 0.163 | Refer to Section 13 for substantial
equivalence | |
| Burst Mode | Pulse per burst | N/A | 3 | N/A | |
| | Burst per second | N/A | 2/60Hz | N/A | |
| | Burst duration | N/A | 36ms | N/A | |
| | Duty cycle | N/A | 36/390ms | N/A | |
| Average DC current
through electrodes when
device is on but no
pulses are being applied
(μA) | 0 | 0 | N/A | Identical to Predicate device #1 | |
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13. Similarity and Difference
The subject device and two predicate devices are designed to be used for temporary relief of pain associated with sore, aching muscle. They all fall into the electrical stimulation device category. The application area of the subject device (shoulder, back, upper extremities (arm) and lower extremities (leg)) is within the scope of the predicate device #1 (K171803). Therefore, it acts as the primary predicate device.
The predicate device #2 (K140650) is used to support the demonstration on some technical characteristics and specifications. Although the subject device has slightly different indications for use in comparison to the predicate device #2, the differences do not constitute a new intended use. They still fall into the electrical stimulation device category.
For basic unit characteristics, the subject device has some differences from predicate device #1; however, it is identical to predicate device #2 except for weight and dimensions which will not raise concern in safety or effectiveness.
For output specifications, the subject device is different from predicate devices in some items; however, those parameters are relatively similar and the subject device falls within the parameters of the two predicate devices. As the subject device complies with ANSI/AAMI ES60601-1 and IEC 60601-2-10, which means we have proved its safety as well as the effectiveness comparing with the predicate device. Therefore, the subject device and predicate devices are substantially equivalence on these parameters. The TENS output of the subject device is as safe and effective as the predicate devices.
14. Conclusion
After conducted a series of non-clinical tests to ensure that our design outputs met the specified design inputs and needs of user, we believe that the subject device, POCKET TENS (EP-300), is substantially equivalent to the predicate devices in safety and effectiveness.