(269 days)
Not Found
No
The summary describes a standard TENS device with different modes and controls, and there is no mention of AI or ML in the device description, intended use, or performance studies.
Yes.
The device is intended for the temporary relief of pain associated with sore and aching muscles, which is a therapeutic purpose.
No
This device is a Transcutaneous Electronic Nerve Stimulator (TENS), which is indicated for temporary relief of pain by providing electrical pulses. It is a therapeutic device, not a diagnostic one, as it does not identify or characterize a medical condition.
No
The device description explicitly states it is a "portable and battery powered multifunctional device" and includes physical components like electrode pads, batteries, and a remote control. It also details hardware testing (electrical safety, EMC, biocompatibility).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the temporary relief of pain associated with sore and aching muscles. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device description clearly states it's a Transcutaneous Electronic Nerve Stimulator (TENS) that delivers electrical pulses to the skin for body stimulation and pain relief. This is consistent with a physical therapy or pain management device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a disease or condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any of those functions.
N/A
Intended Use / Indications for Use
Transcutaneous Electronic Nerve Stimulator is indicated for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
Product codes
NUH
Device Description
Transcutaneous Electronic Nerve Stimulator (Models: KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2491, KTR-2492, KTR-2493, KTR-2494) is a portable and battery powered multifunctional device, offering Transcutaneous Electronic Nerve Stimulator. They can give certain electrical pulse through electrode pads placed on the skin to help users to enjoy body stimulation.
For models: KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2301, KTR-2302, KTR-2342 have 3 operation modes:
For models: KTR-2491, KTR-2493, KTR-2493, KTR-2494 have 15 operation modes, 9 manual mode, and 6 automatic mode. They can be remotely controlled with an accessory remote control. And there is a LCD displays on remote control, which display mode and treatment time.
The electronic stimulator module has unified the operating elements of ON/OFF button. Intensity adjust button and Mode selection button.
The device is equipped with accessories of electrode pads, batteries and remote control (For KTR-249X series).
The electrode pads are complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are interchangeable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
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)
Transcutaneous Electronic Nerve Stimulator has been evaluated the safety and performance by lab bench testing as following:
- Electrical safety test according to IEC 60601-1. IEC 60601-1-11 and IEC 60601-2-10 standards
- Electromagnetic compatibility test according to IEC 60601-1-2 standard
- Biocompatibility test according to ISO 10993-1, ISO 10993-5 and ISO 10993-10 standards
- Usability test according to IEC 62366-1 standard
- Software verification and validation test according to the requirements of the FDA "Guidance for Pre-Market Submissions and for Software Contained in Medical Devices"
- The waveform test report has also been conducted to verify the output specifications of the device according to Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use and Guidance for Powered Muscle Stimulator for Muscle Conditioning
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 19, 2020
Shenzhen Kentro Medical Electronics Co., Ltd Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. Room 2231, Building 1, Ruifeng center, Kaichuang road, Huangpu district Guangzhou, Guangdong 51006 China
Re: K200237
Trade/Device Name: Transcutaneous Electronic Nerve Stimulator Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH Dated: July 15, 2020 Received: July 21, 2020
Dear Cassie Lee:
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
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
2
Indications for Use
510(k) Number (if known) K200237
Device Name
(Model: KTR-2401, KTR-2412, KTR-2412, KTR-2412, KTR-2302, KTR-2341, KTR-2342, KTR-2491, KTR-2492, KTR-2493, KTR-2494)
Indications for Use (Describe)
Transcutaneous Electronic Nerve Stimulator is indicated for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, 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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3
Sponsor: | Shenzhen Kentro Medical Electronics Co., Ltd |
---|---|
Subject Device: | Transcutaneous Electronic Nerve Stimulator, Model: KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2491, KTR-2492, KTR-2493, KTR-2494 |
510(k) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
Submitter's Information 1.
- 510(k) Owner's Name: Shenzhen Kentro Medical Electronics Co., Ltd �
- Establishment Registration Number: 3013671142 �
- Address: No.3, Xihu industry zone, Xikeng Village, Henggang Town, Longgang District, Shenzhen, � Guangdong, China
- Tel: +86-755-33825998 �
- Fax: +86-755-33825996 �
- Contact Person: Zewu Zhang �
- � Email: kentro@kentro.com.cn
Application Correspondent: 2.
- � Contact Person: Ms. Cassie Lee
- Guangzhou GLOMED Biological Technology Co., Ltd. �
- Address: 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, � Guangdong, China
- � Tel: +86 20 8266 2446
- � Email: regulatory@glomed-info.com
3. Subject Device Information
- Transcutaneous Electronic Nerve Stimulator � Trade Name:
- KTR-2401. KTR-2402. KTR-2411. KTR-2412. KTR-2301. KTR-2302, KTR-2341, KTR-2342, KTR-2491, KTR-2492, � Model: KTR-2493, KTR-2494 Electronic Stimulator � Common Name:
- Stimulator, Nerve, Transcutaneous, Muscle, Powered, For Classification name: � Muscle Conditioning, Over-The-Counter Neurology, Physical Medicine
- Review Panel: �
- NUH Product Code: �
- ll � Regulation Class:
- 890.5850 � Regulation Number:
4. Predicate Device Information
| Sponsor | M.I.TECH Co., Ltd. | Shenzhen Kentro Medical
Electronics Co., Ltd | Guangzhou Xinbo
Electronic Co., Ltd. |
|--------------------------|--------------------|-------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Device Name
and Model | HANAROCare ReJu | Transcutaneous Electrical
Nerve Stimulator
Model:KTR-206, KTR-208,
KTR-209 | Pain Therapy Device
Model: P.T.S-II, P.T.S-IIA,
P.T.S-IIB, CP-I |
4
Shenzhen Kentro Medical Electronics Co., Ltd Sponsor:
Transcutaneous Electronic Nerve Stimulator, Model: KTR-2401, KTR-2402, KTR-2411. KTR-2412. KTR-2301. KTR-2302. KTR-2341. KTR-2342. KTR-2491. Subject Device: KTR-2492, KTR-2493, KTR-2494
510(k) Number | K160893 (Primary) | K183288 | K163611 |
---|---|---|---|
Product Code | NUH | NUH, NGX, NYN | NUH, NGX, NYN |
Regulation Number | 882.5890 | 882.5890 | 882.5890 |
Regulation Class | II | II | II |
5. Device Description
Transcutaneous Electronic Nerve Stimulator (Models:
KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2491, KTR-2492, KTR-2493, KTR-2494) is a portable and battery powered multifunctional device, offering Transcutaneous Electronic Nerve Stimulator. They can give certain electrical pulse through electrode pads placed on the skin to help users to enjoy body stimulation.
For models: KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2301, KTR-2302, KTR-2342 have 3 operation modes:
For models: KTR-2491, KTR-2493, KTR-2493, KTR-2494 have 15 operation modes, 9 manual mode, and 6 automatic mode. They can be remotely controlled with an accessory remote control. And there is a LCD displays on remote control, which display mode and treatment time.
The electronic stimulator module has unified the operating elements of ON/OFF button. Intensity adjust button and Mode selection button.
The device is equipped with accessories of electrode pads, batteries and remote control (For KTR-249X series).
The electrode pads are complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are interchangeable.
6. Intended Use / Indications for Use
Transcutaneous Electronic Nerve Stimulator is indicated for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
7. Test Summary
Transcutaneous Electronic Nerve Stimulator has been evaluated the safety and performance by lab bench testing as following:
- Electrical safety test according to IEC 60601-1. IEC 60601-1-11 and IEC 60601-2-10 standards �
- � Electromagnetic compatibility test according to IEC 60601-1-2 standard
- � Biocompatibility test according to ISO 10993-1, ISO 10993-5 and ISO 10993-10 standards
- Usability test according to IEC 62366-1 standard �
- � Software verification and validation test according to the requirements of the FDA "Guidance for Pre-Market Submissions and for Software Contained in Medical Devices"
5
Sponsor: | Shenzhen Kentro Medical Electronics Co., Ltd |
---|---|
Transcutaneous Electronic Nerve Stimulator, Model: KTR-2401, KTR-2402, KTR- | |
Subject Device: | 2411, KTR-2412, KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2491, |
KTR-2492, KTR-2493, KTR-2494 |
- ◆ The waveform test report has also been conducted to verify the output specifications of the device according to Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use and Guidance for Powered Muscle Stimulator for Muscle Conditioning
8. Comparison to predicate device and conclusion
The technological characteristics, features, specifications, materials, mode of operation, and intended use of Transcutaneous Electronic Nerve Stimulator is substantially equivalent to the primary predicate device quoted above.
The differences between the subject device and primary predicate device do not raise new issues of safety or effectiveness.
| Elements
of
Comparis
on | Subject Device | Predicate Device 1
(primary) | Predicate Device 2 | Predicate Device 3 | Remark |
|-----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Device
Name and
Model | Transcutaneous
Electronic Nerve
Stimulator
Model:
KTR-2401,KTR-2402,KTR-2411,KTR-
2412,KTR-2301,KTR-2302,KTR-2341,KTR-
2342,KTR-2491,KTR-2492,KTR-2493,KTR-
2494 | HANAROCare ReJu | Transcutaneous
Electrical Nerve
Stimulator
Model: KTR-206,
KTR-208, KTR-209 | Pain Therapy
Device, Models:
P.T.S-II, P.T.S-IIA,
P.T.S-IIB, CP-I | -- |
| 510(k)
Number | Applying | K160893 | K183288 | K163611 | -- |
| Product
code | NUH | NUH | NUH, NGX, NYN | NUH, NGX, NYN | SE |
| Intended
Use | Transcutaneous
Electronic Nerve
Stimulator is
indicated for
temporary relief of
pain associated with
sore and aching
muscles in the
shoulder, waist, back,
neck, upper
extremities (arm) and
lower extremities
(leg) due to strain
from exercise or
normal household
work activities. | HANAROCare ReJu
is indicated for
temporary relief of
pain associated with
sore and aching
muscles in the
shoulder, waist,
back, neck, upper
extremities (arm)
and lower
extremities (leg) due
to strain from
exercise or normal
household work
activities. | To be used for
temporary relief of
pain associated with
sore and aching
muscles in the
shoulder, back,
arm, leg, foot, due
to strain from
exercise or normal
household and work
activities. | To be used for
temporary relief of
pain associated with
sore and aching
muscles in the
upper and lower
back, back of the
neck, upper
extremities
(shoulder and arm),
lower extremities
(leg and feet) due to
strain from exercise
or normal
household work
activities by
applying current to
stimulate nerve.
To be used for
symptomatic relief
and management of | SE |
| Elements
of
Comparison | Subject Device | Predicate Device 1
(primary) | Predicate Device 2 | Predicate Device 3 | Remark |
| | | | | chronic, intractable pain and relief of pain associated with arthritis (Choose Mode B or C).
To stimulate healthy muscles in order to improve and facilitate muscle performance (Choose Mode A).
To temporarily increase local blood | |
| Power
Source(s) | For KTR-23XX series: CR2032;
3Vdc; 240mAh
For KTR-24XX series: PL301526;
3.7Vdc, 250mAh | Lithium-polymer, 3.7V | KTR-206: 2 AAA batteries (DC3V) | DC 3.0V, 2 x AAA | SE
Note 1 |
| Patient
Leakage
Current | NC DC: 0.5µA | DC: 0.5µA | | DC: 0.5µA | |
| | SFC DC: 0.6μΑ | DC: 0.6μΑ | N/A (Battery operated) | DC: 0.6μΑ | SE |
| Average DC current through electrodes when device is on but no pulses are being applied |
• Mode 1: 0.154
• Mode 2: 0.377
• Mode 3: 0.437
• Combination: This
mode cycles the | KTR-206:
0.26mA/cm²
KTR-208:
0.22mA/cm²
KTR-209: 0.4mA/
cm² | 0.073mA/cm² | SE
Note 2 |
| Elements
of
Comparis
on | Subject Device | Predicate Device 1
(primary) | Predicate Device 2 | Predicate Device 3 | Remark |
| | | above modes.
• Mode 1: 0.051
• Mode 2: 0.124
• Mode 3: 0.144
• Combination: This
mode cycles the
above modes. | | | |
| Maximum
Average
Power
Density(
@500Ω) | 0.037 (mW/cm²) | (±10%)
• Mode 1: 0.15
• Mode 2: 0.893
• Mode 3:1.2
• Combination: This
mode cycles the
above modes.
• Mode 1: 0.049
• Mode 2: 0.295
• Mode 3: 0.396
• Combination: This
mode cycles the
above | KTR-206: 0.001W/
cm²
KTR-208:
0.0008W/cm²
KTR-209:
0.0025W/cm² | 0.056mW/cm² | SE
Note 2 |
| Environm
ent for
operating | Environment
temperature: +5°C-
+40°C; Environment
humidity: 0%-
80%RH; Atmospheric
environment
conditions: 860hPa-
1060hPa. | Unknown | Environment
temperature: +5°C-
+40°C; Environment
humidity: 0%-
80%RH;
Atmospheric
environment
conditions: 860hPa-
1060hPa. | Temperature:
540°C,106kPa | SE |
Humidity: ≤80%RH,
Atmospheric
Pressure:
86
| Environm
ent for
storage | Environment
temperature: 0°C-
+55°C; Environment
humidity: 0-93%RH;
Atmospheric
environment
conditions: 500hPa-
1060hPa. | Unknown | Environment
temperature: 0°C-
+55°C; Environment
humidity: 0-93%RH;
Atmospheric
environment
conditions: 500hPa-
1060hPa. | Temperature:
Main Unit: -
2055°C,20°C
Electrode Pad:
10
Humidity: 1095%106
RH,
Atmospheric
Pressure: 50
kPa | SE |
| Biocompa | All user directly | -ISO 10993-5: | All user directly | All user directly | SE |
| Elements
of
Comparison
on | Subject Device | Predicate Device 1
(primary) | Predicate Device 2 | Predicate Device 3 | Remark |
| tibility | contacting materials
are compliance with
ISO10993-5 and
ISO10993-10
requirements. | Cytotoxicity Test
(Aggar Diffusion
Assay)
- ISO 10993-10:
Primary skin irritation
study in rabbits (4
hour semi-occlusive
application) - ISO 10993-10:
Contact
Hypersensitivity in
Albino Guiana Pigs
Maximization Test | contacting materials
are compliance with
ISO10993-5 and
ISO10993-10
requirements. | contacting materials
are compliance with
ISO10993-5 and
ISO10993-10
requirements. | |
| Electrical
Safety | Comply with IEC
60601-1, IEC 60601-
1-11 and IEC 60601-
2-10 | Comply with IEC
60601-1, IEC 60601-
1-11 and IEC 60601-
2-10 | Comply with IEC
60601-1, IEC
60601-1-11 and IEC
60601-2-10 | Comply with IEC
60601-1 and IEC
60601-2-10 | SE |
| EMC | Comply with IEC
60601-1-2 | Comply with IEC
60601-1-2 | Comply with IEC
60601-1-2 | Comply with IEC
60601-1-2 | SE |
6
7
Sponsor: Shenzhen Kentro Medical Electronics Co., Ltd Transcutaneous Electronic Nerve Stimulator, Model: KTR-2401, KTR-2402, KTR-Subject Device: 2411, KTR-2412, KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2491, KTR-2492, KTR-2493, KTR-2494
8
9
10
Transcutaneous Electronic Nerve Stimulator, Model: KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2491, KTR-2492, KTR-2493, KTR-2494
Subject Device:
11
12
Shenzhen Kentro Medical Electronics Co., Ltd Sponsor:
Transcutaneous Electronic Nerve Stimulator, Model: KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2491, Subject Device: KTR-2492, KTR-2493, KTR-2494
Comparison in Detail(s):
Note 1:
Although the "Power source", "Weight" , "Dimensions of main unit (mm)" are a little different from the predicate device, but the differences will not raise any safety or effectiveness issue.
Note 2:
Although the "Number of Output Modes", "Maximum Output Voltage", "Maximum Output Current", "Pulse Duration", "Pulse frequency", "Maximum Phase Charge" "Maximum Average Current", "Maximum Current Density(r.m.s )" and "Maximum Average Power Density" of subject device are little different from the predicate device, their maximum peak voltage are very similar, and are all comply with IEC 60601-1 and IEC 60601-2-10 requirements. So the differences of the function specifications will not raise any safety or effectiveness issue.
Final Conclusion:
Based on the above analysis and tests performed, it can be concluded that the performance and function of the Transcutaneous Electronic Nerve Stimulator is Substantially Equivalent (SE) to the primary predicate device.