(428 days)
No
The device description and performance studies focus on standard electrical stimulation functionalities and safety testing, with no mention of AI or ML algorithms for mode selection, intensity adjustment, or other features.
Yes.
The "Intended Use / Indications for Use" section explicitly states that the device is "To be used for temporary relief of pain associated with sore and aching muscles" (TENS mode) and "to stimulate healthy muscles in order to improve and facilitate muscle performance" (EMS mode), which are therapeutic purposes.
No
This device is described as a "Low-frequency Multi-function physiotherapy instrument" that delivers electrical stimulation (TENS, EMS, FITNESS) for pain relief, muscle stimulation, and muscle performance improvement. Its intended use is therapeutic, not diagnostic.
No
The device description clearly states it is a "portable and battery powered multifunctional device" with physical components like electrode pads, electrode wires, and batteries, in addition to the electronic stimulatory module with operating elements and a display screen. This indicates it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is a "Low-frequency Multi-function physiotherapy instrument" that applies electrical pulses to the skin using electrode pads. Its intended uses are for pain relief (TENS), muscle stimulation (EMS), and fitness.
- Lack of Sample Analysis: There is no mention of this device analyzing any biological samples from the body. It directly interacts with the body's nerves and muscles through electrical stimulation.
Therefore, this device falls under the category of a physical therapy or electrotherapy device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
KTR-2210, KTR-2220, KTR-2230: (TENS, EMS, FITNESS)
TENS (Mode1~20): 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 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 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
Low-frequency Multi-function physiotherapy instrument (Models: KTR-2210) is a portable and battery powered multifunctional device, offering Transcutaneous Electronic Nerve Stimulator (TENS), Electronic Muscle Stimulator (EMS) and FITNESS qualities.
Low-frequency Multi-function physiotherapy instrument (Models: KTR-2210) has 50 operation modes, which can give certain electrical pulse through 4 pcs of electrode pads placed on the skin to help users to enjoy body massage.
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. All the accessories, including electrode pads, electrode wire, and batteries can only be changed by special person.
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, 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): 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 contains 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.
September 25, 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: K191982
Trade/Device Name: Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-222, KTR-2212) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: March 20, 2020 Received: June 29, 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
1
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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,
Heather Dean, PhD Assistant Director, Acute Injury Devices Team 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
2
Indications for Use
510(k) Number (if known) K191982
Device Name
Low-frequency Multi-function physiotherapy instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2211, KTR-2211, KTR-2232, KTR-2212)
Indications for Use (Describe)
KTR-2210, KTR-2220, KTR-2230: (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 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 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 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) |
|---|---|
| ----------------------------------------------------------------------- | --------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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.
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 (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-in fo.com
Subject Device Information 3.
- � Trade Name: 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) Common Name: � Electronic Stimulator
- Stimulator, Nerve, Transcutaneous, Muscle, Powered, For � Classification name: Muscle Conditioning, Over-The-Counter
- � Review Panel: Neurology, Physical Medicine
- � Product Code: NUH, NGX
- � Regulation Class: ll
- Regulation Number: � 882.5890, 890.5850
4. Predicate Device Information
| Primary Predicate Device | Reference Device 1 | Reference Device 2 | |
|---|---|---|---|
| Sponsor | Shenzhen OSTO Technology | ||
| Company Limited | Guangzhou Xinbo Electronic | ||
| Co., Ltd. | Shenzhen OSTO | ||
| Technology Co., Ltd. | |||
| Device | Health Expert Electronic | Pain Therapy Device | Intelligent Wireless Fitness |
| Apparatus |
4
| Name and
Model | Stimulator, Model: AST-300C
and AST-300D | Models:P.T.S-11, P.T.S-
IIA, P.T.S-118 , CP-I | Models: AST-301, AST-302,
AST-303 |
|----------------------|---------------------------------------------|--------------------------------------------------|--------------------------------------|
| 510(k)
Number | K133929 | K163611 | K182136 |
| Product
Code | NUH, NGX | NUH, NGX | NGX |
| Regulation
Number | 882.5890, 890.5850 | 882.5890, 890.5850 | 890.5850 |
| Regulation
Class | II | II | II |
5. Device Description
Low-frequency Multi-function physiotherapy instrument (Models: KTR-2210) is a portable and battery powered multifunctional device, offering Transcutaneous Electronic Nerve Stimulator (TENS), Electronic Muscle Stimulator (EMS) and FITNESS qualities.
Low-frequency Multi-function physiotherapy instrument (Models: KTR-2210) has 50 operation modes, which can give certain electrical pulse through 4 pcs of electrode pads placed on the skin to help users to enjoy body massage.
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. All the accessories, including electrode pads, electrode wire, and batteries can only be changed by special person.
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
KTR-2210, KTR-2220, KTR-2230: CTENS, EMS, FITNESS)
TENS (Mode1~20:) 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 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.
5
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, 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
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.
| Elements of
Comparison | Subject Device | Primary Predicate
Device | Reference Device
1 | Reference
Device 2 | Remark | |
|--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|--------------|
| Device Name and
Model | 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 | Low-frequency Multi-
function physiotherapy
instrument
Model: AST-300C and
AST-300D | Pain Therapy
Device, Models:
P.T.S-11, P.T.S-IIA,
P.T.S-11B, CP-I | Intelligent
Wireless
Fitness
Apparatus
Models: AST-
301, AST-302,
AST-303 | | |
| 510(k) Number | Applying | K133929 | K163611 | K182136 | | |
| Intended Use | KTR-2210 , KTR-2220 ,
KTR-2230 : (TENS , EMS, FITNESS)
TENS (Mode120): To8)
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 | PMS (Mode 1
It is intended to
stimulate healthy
muscles in order to
improve and facilitate
muscle performance.
TENS (Mode 925)40): It is
To be used for
temporary relief of pain
associated with sore
and aching muscles in
the shoulder, waist, | 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 | Intelligent
Wireless
Fitness
Apparatus is
indicated to be
used for:
Improvement
of abdominal
tone,
strengthening
of the | SE
Note 1 | |
| Elements of
Comparison | Subject Device | Primary Predicate
Device | Reference Device
1 | Reference
Device 2 | Remark | |
| | household work activities
by applying current to
stimulate nerve.
EMS (Mode 21
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 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. | 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. | 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 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 | development
of firmer
abdomen.
Strengthening,
toning and
firming of
buttocks and
thighs. | | |
| Power Source(s) | DC 4.5V (3*AAA LR03
battery), 180mA | Adaptor Input 100-
240Vac, 50-60Hz,
0.1A
Output 5Vdc, 1A
Unit Input 5Vdc, 1A | DC 3.0V, 2 x AAA | Adapter
(Model
HDMU05E-
050100,
HDMU05B-
050100,
HDMU05U-
050100) Input
100-240 Vac;
50/60 Hz;
0.3A; | SE
Note 2 | |
| Elements of
Comparison | Subject Device | Primary Predicate
Device | Reference Device
1 | Reference
Device 2 | Remark | |
| | | | | | Output: 5 V;
1 A
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 | AC: 54.5µA,
DC: 0.5μA | DC: 0.5µA |