(426 days)
No
The summary describes a standard TENS/EMS/Fitness device with pre-set modes and intensity controls. There is no mention of adaptive algorithms, learning capabilities, or any technology that would typically be associated with AI/ML.
Yes
The device is described as a "physiotherapy instrument" and its intended uses include temporary pain relief (TENS) and stimulating muscles to improve performance (EMS, FITNESS), which are all therapeutic functions.
No
The device is described as a "Low-frequency Multi-function physiotherapy instrument" intended for temporary pain relief, muscle stimulation, and muscle performance improvement (TENS, EMS, FITNESS functions). Its purpose is therapeutic, not to diagnose a condition.
No
The device description explicitly states it is a "portable and battery powered multifunctional device" with "operating elements of ON/OFF Key, Display screen, Mode Selection key and Intensity Modification keys," and is "equipped with accessories of electrode wires, and batteries." This indicates it is a hardware device that utilizes software for its functionality, not a software-only device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly describes the device as a physiotherapy instrument for pain relief (TENS) and muscle stimulation/strengthening (EMS, FITNESS). These are all applications that involve interacting with the human body directly, not testing samples in vitro (outside the body).
- Device Description: The description details a portable, battery-powered device that applies electrical pulses to the skin via electrode pads. This aligns with a physical therapy device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
Therefore, this device falls under the category of a medical device used for physical therapy and pain management, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
KTR-2240, KTR-2250, KTR-2610, KTR-2640, KTR-2650: (TENS, EMS, FITNESS)
TENS (Mode 1~20): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
EMS (Mode 21~40): It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.
FITNESS (Mode 41~50): Improvement of abdominal tone, strengthening of the abdominal muscle development of firmer abdomen.
KTR-2241, KTR-2251, KTR-2242, KTR-2252, KTR-2611, KTR-2641, KTR-2651, KTR-2612, KTR-2642, KTR-2652: (TENS)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
Product codes (comma separated list FDA assigned to the subject device)
NUH, NGX
Device Description
The Low-frequency Multi-function physiotherapy instrument is a portable and battery powered multifunctional device. The low-frequency multi-function physiotherapy instrument (models: KTR-2240, KTR-2250, KTR-2610, KTR-2640, KTR-2650) offering Transcutaneous Electronic Nerve Stimulator (TENS), Electronic Muscle Stimulation. It has 50 operation modes, which can give certain electrical pulse through electrode pads placed on the skin to help users to enjoy body stimulation. And the TENS (Mode 120) is to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve. EMS (Mode 2140) is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. FITNESS (Mode 41~50) is indicated for the improvement of abdominal muscle tone, for the strengthening of the abdominal muscles and for the development of a firmer abdomen.
The low-frequency multi-function physiotherapy instrument (models: KTR-2241, KTR-2242, KTR-2252, KTR-2611, KTR-2641, KTR-2612, KTR-2612, KTR-2652) offering Transcutaneous Electronic Nerve Stimulator (TENS). It has 15 operation mode, and 6 automatic mode, which can give certain electrical pulse through electrode pads placed on the skin to help users to enjoy body stimulation. The TENS (Mode 1-15) is intended to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
The electronic stimulatory module has the operating elements of ON/OFF Key, Display screen, Mode Selection key and Intensity Modification keys. The LCD display screen can show selected mode and program, output intensity, stimulate frequency, and time remaining of an application mode. The device is equipped with accessories of electrode wires, and batteries. The electrode wire is used to connect the patches to the main unit. 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, back of the neck, arm, leg, and foot
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Low-frequency Multi-function physiotherapy instrument has been evaluated the safety and performance by lab bench testing as following:
- Electrical safety test according to IEC 60601-1-11 and IEC 60601-2-10 standards
- Electromagnetic compatibility test according to IEC 60601-1-2 standard
- 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 body-contacting components of this device are electrode patches. We have directly purchased the electrode patches from qualified supplier (Shenzhen Quality Medical Technology Co., Ltd.) which has obtained FDA clearance with a 510(k) number of K171381 and been marketed to US market. So we have reason to believe that the electrode patches are safe for the users. The electrode patches comply with the following standards.
- ISO 10993-5: 2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
The conclusion drawn from the nonclinical tests demonstrate that the subject devices Multi-function physiotherapy instrument (Model: KTR-2240, KTR-2250, KTR-2251, KTR-2242, KTR-2610, KTR-2640, KTR-2640, KTR-2611, KTR-2641, KTR-2641, KTR-2641, KTR-2641, KTR-2651, KTR-2612, KTR-2642, KTR-2652) as safe, as effective as well as the legally marketed device identified in K191982. K163611 and K182136.
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
March 25, 2021
Image /page/0/Picture/1 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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, 51006 Cn
Re: K200177
Trade/Device Name: Low-frequency Multi-function physiotherapy instrument (Model: KTR-2240, KTR-2250, KTR-2241, KTR-2251, KTR-2242, KTR-2252, KTR-2610, KTR-2640, KTR-2650, KTR-2611, KTR-2641, KTR-2651, KTR-2612, KTR-2642, KTR-2652) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: December 21, 2020 Received: December 28, 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 Assistant 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
Indications for Use
510(k) Number (if known) K200177
Device Name
Low-frequency Multi-function physiotherapy instrument (Model: KTR-2240, KTR-2250, KTR-2241, KTR-2251, KTR-2252, KTR-2610, KTR-2640, KTR-2650, KTR-2611, KTR-2641, KTR-2651, KTR-2612, KTR-2642, KTR-2652)
Indications for Use (Describe)
KTR-2240,KTR-2250,KTR-2610,KTR-2640,KTR-2650:(TENS, EMS, FITNESS)
TENS (Model~20): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
EMS (Mode 2140): It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. FITNESS (Mode 4150): Improvement of abdominal tone, strengthening of the abdominal muscle development of firmer abdomen.
KTR-2241,KTR-2251,KTR-2242,KTR-2252,KTR-2611,KTR-2641,KTR-2612,KTR-2612,KTR-2652: (TENS)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| 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
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter's Information
- 510(k) Owner's Name: Shenzhen Kentro Medical Electronics Co., Ltd �
- Establishment Registration Number: 3013671142 �
- � Address: No. 11, Shanzhuang Road, Xikeng Village, Yuanshan Street, Longgang District, ShenZhen, China
- � Tel: +86-755-33825998
- Fax: +86-755-33825996 �
- � Contact Person: Zewu Zhang (General Manger)
- Email: kentro@kentro.com.cn �
2. Application Correspondent:
- � 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
- Low-frequency Multi-function physiotherapy instrument � Trade Name: Stimulator, Muscle, Powered, For Muscle Conditioning; Common Name: �
- Stimulator, Nerve, Transcutaneous, Over-The-Counter
- Powered muscle stimulator, Transcutaneous electrical nerve � Classification name: stimulator for pain relief
- Neurology, Physical Medicine Review Panel: �
- � Product Code: NUH, NGX
- Regulation Class: ll �
- � Regulation Number: 882.5890, 890.5850
4. Predicate Device Information
| Sponsor | Shenzhen Kentro Medical
Electronics Co., Ltd | Guangzhou Xinbo
Electronic Co., Ltd. | Shenzhen OSTO
Technology Co., Ltd. |
|--------------------------|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Device Name and
Model | KTR-2230, KTR-2220, KTR-
2210, KTR-2231, KTR-2221,
KTR-2211, KTR-2232, KTR-
2222, KTR2212 | Pain Therapy Device
Models: P.T.S-II, P.T.S-
IIA, P.T.S-IIB, CP-I | Intelligent Wireless
Fitness Apparatus
Models: AST-301, AST-
302, AST-303 |
| 510(k) Number | K191982 | K163611 | K182136 |
| Product Code | NUH, NGX | NUH, NGX, NYN | NGX |
4
| Regulation Number | 882.5890, 890.5850 | 882.5890, 890.5850 | 890.5850 |
|---|---|---|---|
| Regulation Class | II | II | II |
| Primary/ Reference | |||
| device | Primary predicate device | Reference device | Reference device |
5. Intended Use / Indications for Use
KTR-2240, KTR-2250, KTR-2610, KTR-2640, KTR-2650: (TENS, EMS, FITNESS)
TENS (Mode 1~20): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
EMS (Mode 21~40): It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.
FITNESS (Mode 41~50): Improvement of abdominal tone, strengthening of the abdominal muscle development of firmer abdomen.
KTR-2241, KTR-2251, KTR-2242, KTR-2252, KTR-2611, KTR-2641, KTR-2651, KTR-2612, KTR-2642, KTR-2652: (TENS)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
6. Device Description
The Low-frequency Multi-function physiotherapy instrument is a portable and battery powered multifunctional device. The low-frequency multi-function physiotherapy instrument (models: KTR-2240, KTR-2250, KTR-2610, KTR-2640, KTR-2650) offering Transcutaneous Electronic Nerve Stimulator (TENS), Electronic Muscle Stimulation. It has 50 operation modes, which can give certain electrical pulse through electrode pads placed on the skin to help users to enjoy body stimulation. And the TENS (Mode 120) is to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve. EMS (Mode 2140) is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. FITNESS (Mode 41~50) is indicated for the improvement of abdominal muscle tone, for the strengthening of the abdominal muscles and for the development of a firmer abdomen.
The low-frequency multi-function physiotherapy instrument (models: KTR-2241, KTR-2242, KTR-2252, KTR-2611, KTR-2641, KTR-2612, KTR-2612, KTR-2652) offering Transcutaneous Electronic Nerve Stimulator (TENS). It has 15 operation mode, and 6 automatic mode, which can give certain electrical pulse through electrode pads placed on the skin to help users to enjoy body stimulation. The TENS (Mode 1-15) is intended to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
The electronic stimulatory module has the operating elements of ON/OFF Key, Display screen, Mode Selection key and Intensity Modification keys.
5
The LCD display screen can show selected mode and program, output intensity, stimulate frequency, and time remaining of an application mode.
The device is equipped with accessories of electrode wires, and batteries. The electrode wire is used to connect the patches to the main unit.
The electrode pads are complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are interchangeable.
7. Test Summary
Low-frequency Multi-function physiotherapy instrument has been evaluated the safety and performance by lab bench testing as following:
- � Electrical safety test according to IEC 60601-1-11 and IEC 60601-2-10 standards
- � Electromagnetic compatibility test according to IEC 60601-1-2 standard
- � 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 body-contacting components of this device are electrode patches. We have directly purchased the electrode patches from qualified supplier (Shenzhen Quality Medical Technology Co., Ltd.) which has obtained FDA clearance with a 510(k) number of K171381 and been marketed to US market. So we have reason to believe that the electrode patches are safe for the users. The electrode patches comply with the following standards.
- � ISO 10993-5: 2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- � ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
8. Comparison to predicate device and conclusion
The technological characteristics, features, specifications, materials, mode of operation, and intended use of Low-frequency Multi-function physiotherapy instrument is substantially equivalent to the predicate devices quoted above.
The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
6
| Elements of Comparison | Subject Device | Predicate Device 1
(Primary predicate
device) | Predicate Device 2
(Reference Device) | Predicate Device 3
(Reference Device) | Remark |
|-----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| Device Name and Model | Low-frequency Multi-
function physiotherapy
instrument
Model: KTR-2240,
KTR-2250, KTR-2241,
KTR-2251, KTR-2242,
KTR-2252, KTR-2610,
KTR-2640, KTR-2650,
KTR-2611, KTR-2641,
KTR-2651, KTR-2612,
KTR-2642, KTR-2652 | Low-frequency Multi-
function
physiotherapy
instrument
Model: KTR-2230,
KTR-2220, KTR-
2210, KTR-2231,
KTR-2221, KTR-
2211, KTR-2232,
KTR-2222, KTR-2212 | Pain Therapy Device,
Models: P.T.S-II,
P.T.S-IIA, P.T.S-IIB,
CP-I | Intelligent Wireless
Fitness Apparatus
Models: AST-301,
AST-302, AST-303 | -- |
| 510(k) Number | K200177 | K191982 | K163611 | K182136 | -- |
| Product code | NUH, NGX | NUH, NGX | NUH, NYN, NGX | NGX | SE |
| Intended Use | KTR-2240, KTR-2250,
KTR-2610, KTR-2640,
KTR-2650: (TENS,
EMS, FITNESS)
TENS (Mode 120):40): It
To be used for temporary
relief of pain
associated with sore
and aching muscles in
the shoulder, waist,
back, back of the neck,
arm, leg, and foot due
to strain from exercise
or normal household
work activities by
applying current to
stimulate nerve.
EMS (Mode 21
is intended to stimulate
healthy muscles in
order to improve and | KTR-2210, KTR-
2220, KTR-2230:
(TENS, EMS,
FITNESS)
TENS (Mode 120):40): It
To be used for
temporary relief of
pain associated with
sore and aching
muscles in the
shoulder, waist, back,
back of the neck, arm,
leg, and foot due to
strain from exercise
or normal household
work activities by
applying current to
stimulate nerve.
EMS (Mode 21
is intended to
stimulate healthy | 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
chronic, intractable
pain and relief of pain | Intelligent Wireless
Fitness Apparatus is
indicated to be used
for: Improvement of
abdominal tone,
strengthening of the
abdominal muscles
development of firmer
abdomen.
Strengthening, toning
and firming of buttocks
and thighs. | SE |
| Elements of Comparison | Subject Device | Predicate Device 1
(Primary predicate
device) | Predicate Device 2
(Reference Device) | Predicate Device 3
(Reference Device) | Remark |
| Power Source(s) | facilitate muscle
performance.
FITNESS (Mode
4150): Improvement50): Improvement
of abdominal tone,
strengthening of the
abdominal muscle
development of firmer
abdomen.
KTR-2241, KTR-2251,
KTR-2242, KTR-2252,
KTR-2611, KTR-2641,
KTR-2651, KTR-2612,
KTR-2642, KTR-2652:
(TENS)
To be used for
temporary relief of pain
associated with sore
and aching muscles in
the shoulder, waist,
back, back of the neck,
arm, leg, and foot due
to strain from exercise
or normal household
work activities by
applying current to
stimulate nerve. | muscles in order to
improve and facilitate
muscle performance.
FITNESS (Mode
41
of abdominal tone,
strengthening of the
abdominal muscles
development of firmer
abdomen.
KTR-2211, KTR-
2221, KTR-2231,
KTR-2212, KTR-
2222, KTR-2232:
(TENS)
To be used for
temporary relief of
pain associated with
sore and aching
muscles in the
shoulder, waist, back,
back of the neck, arm,
leg, and foot due to
strain from exercise
or normal household
work activities by
applying current to
stimulate nerve. | 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 model KTR-2240,
KTR-2250, KTR-2241,
KTR-2251, KTR-2242,
KTR-2252: DC 4.5V
(3xAAA LR03 battery),
180mA
For model KTR-2610 | DC 4.5V (3*AAA
LR03 battery), 180mA | DC 3.0V, 2 x AAA | Adapter (Model
HDMU05E-050100,
HDMU05B-050100,
HDMU05U-050100)
Input: 100-240 Vac;
50/60 Hz; 0,3A;
Output: 5 V; 1A | SE |
| Elements of Comparison | Subject Device | Predicate Device 1
(Primary predicate
device) | Predicate Device 2
(Reference Device) | Predicate Device 3
(Reference Device) | Remark |
| | KTR-2640, KTR-2650,
KTR-2611, KTR-2641,
KTR-2651, KTR-2612,
KTR-2642, KTR-2652:
3.7V/250mAh lithium
battery | | | Rechargeable Lithium-
ion Battery: 3.7Vdc | |
| -Method of Line Current Isolation | Type BF Applied Part | Type BF Applied Part | Type BF Applied Part | Type BF Applied Part | SE |
| Patient Leakage
Current | NC | DC: 0.5µA | DC: 0.5μA | DC: 0.5μA |