(63 days)
Not Found
No
The device description details fixed modes, intensity levels, and timing controlled by physical buttons. There is no mention of adaptive learning, data analysis for personalized treatment, or any other characteristic typically associated with AI/ML. The performance studies focus on standard electrical safety, biocompatibility, and software validation, not AI/ML performance metrics.
Yes
The device is described as a TENS (Transcutaneous Electrical Nerve Stimulation) and PMS (Powered Muscle Stimulator) device, which are explicitly designed for temporary relief of pain and to improve muscle performance via electrical stimulation and heating. These functions are therapeutic as they aim to alleviate symptoms and improve physical function.
No
Explanation: The "Intended Use / Indications for Use" section states that the device is intended for "temporary relief of pain" and to "stimulate healthy muscles in order to improve and facilitate muscle performance," not for diagnosing a condition or disease.
No
The device description clearly outlines a physical device with buttons, an LCD screen, electrode wires, electrode pads, and conductive heads. It also mentions electrical safety, electromagnetic compatibility, and biocompatibility testing, which are relevant to hardware components. While software verification and validation are mentioned, the device is not solely software.
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 the device is a low-frequency stimulator with TENS, PMS, and heating functions. These functions involve applying electrical stimulation and heat to the body, not analyzing samples from the body.
- Intended Use: The intended uses are for pain relief and muscle stimulation, which are therapeutic applications, not diagnostic ones.
- Device Description: The components and operation described (electrodes, heating elements, buttons for intensity and mode) are consistent with a physical therapy or pain management device, not an IVD.
Therefore, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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. It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
PMS: It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.
Heating: It is intended for temporary relief of minor aches and pains.
Product codes
NUH, NGX, NYN, GZJ, IPF, IRT
Device Description
The Low-frequency stimulator is a portable device. It has 10 modes: 9 stimulation modes each has 99 levels of intensity and 1 heating mode has 3 levels of heating intensity, which can give certain stimulation to help the users relax their muscle and relief their pain.
The Low-frequency stimulator has 7 buttons on the main unit:
Press Power button to turn on/off the device.
Press "Mode+" and "Mode-" buttons to select 9 stimulation modes;
Press "Intensity+" and "Intensity-" to increase or decrease the stimulus intensity, there are a total of 99 intensities to choose from;
Press "Heat" to adjust the heating temperature, there are three temperatures (38℃, 40℃ and 43℃) that can be adjusted.
Press "Time" to adjust the treatment time, increasing by five minutes each time, up to 60 minutes. It will automatically shut down in 30 minutes by default when it is turned on.
The LCD screen can show stimulation intensity, heating intensity, heating intensity and time remaining of an application mode.
All the functions of the device can only be controlled by the button on the main unit. The device is equipped with an adapter, bandage, a pair of electrode wire. The electrode wire is used to connect the electrode pads to the main unit. There are four conductive heads on the main unit, which are mainly composed of stainless steel sheets and giving users stimulation and heating functions, and help users relieve knee pain. The stimulation and heating functions can happen simultaneously or independently by control the button on the main unit. When in use, the main unit is fixed with a bandage, and the electrode sheet is placed at the relevant treatment site according to the instructions. The electrode pads can be used on the guidance site for stimulation only when connected to the host. There are two models of the device, which differ only in appearance.
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 of the neck, arm, leg, and foot
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)
Non-clinical testing was conducted to verify that the subject device met all design specifications, demonstrated safety based on current industry standards, and to demonstrate substantial equivalence to the predicate. The following tests were performed:
- 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 10993-5 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
No clinical study is included in this submission.
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 contains the logo of the U.S. Food & 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.
November 22, 2021
Shenzhen OSTO Technology Co., Ltd. % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou, Guangdong 510700 China
Re: K212989
Trade/Device Name: Low-frequency Stimulator (Model: AST-645, AST-646) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH, NGX, NYN, GZJ, IPF, IRT Dated: September 15, 2021 Received: September 20, 2021
Dear Cassie Lee:
We have reviewed vour 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.
Amber Ballard, PhD 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
2
Indications for Use
510(k) Number (if known) K212989
Device Name
Low-frequency Stimulator (Model: AST-645, AST-646)
Indications for Use (Describe) 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.
It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
PMS:
It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.
Heating:
It is intended for temporary relief of minor aches and pains.
| 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
510(k) Summary for K212989
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 OSTO Technology Company Limited
- � Establishment Registration Number: 3011564440
- � Address: No.43 Longfeng Road, Xinsheng Community, Longgang Street, Longgang District, Shenzhen City, Guangdong Province, China
- � Tel: +86-755-29769546
- � Fax: +86-755-29769540
- � Contact Person: Li Yang (General Manger)
- Email: annaosto@163.com �
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
- � Trade Name: Low-frequency stimulator (Model AST-645, AST-646)
- � Common Name: Over-the-counter Transcutaneous Electrical Nerve Stimulator
- � Classification name: Transcutaneous Electrical Nerve Stimulator For Pain Relief
- � Review Panel: Physical Medicine
- NUH, NGX, NYN, GZJ, IPF, IRT Product Code: �
- ll � Requlation Class:
- 882.5890 Regulation Number: �
-
- Predicate Device Information
Primary Predicate Devic Information
- Jkh Usa, LLC � Sponsor
- JKH Stimulator Plus � Device Name and Model
- � 510(k) Number K191151
4
- NUH, NGX, NYN, GZJ, IPF, IRT � Product Code
- � Regulation Number 882.5890
- Requlation Class � 11
Secondary Predicate Device Information
- Shenzhen OSTO Technology Company Limited Sponsor
- Health Expert Electronic Stimulator (Model: AST-300L) � Device Name and Model
- K190783 � 510(k) Number
- NUH, NGX � Product Code
- 882.5890, 890.5850 � Regulation Number
- � Requlation Class ll
2. Device Description
�
The Low-frequency stimulator is a portable device. It has 10 modes: 9 stimulation modes each has 99 levels of intensity and 1 heating mode has 3 levels of heating intensity, which can give certain stimulation to help the users relax their muscle and relief their pain.
The Low-frequency stimulator has 7 buttons on the main unit:
Press Power button to turn on/off the device.
Press "Mode+" and "Mode-" buttons to select 9 stimulation modes;
Press "Intensity+" and "Intensity-" to increase or decrease the stimulus intensity, there are a total of 99 intensities to choose from;
Press "Heat" to adjust the heating temperature, there are three temperatures(38℃, 40℃ and 43℃) that
can be adjusted.
Press "Time" to adjust the treatment time, increasing by five minutes each time, up to 60 minutes. It will automatically shut down in 30 minutes by default when it is turned on.
The LCD screen can show stimulation intensity, heating intensity, heating intensity and time remaining of an application mode.
All the functions of the device can only be controlled by the button on the main unit. The device is equipped with an adapter, bandage, a pair of electrode wire. The electrode wire is used to connect the electrode pads to the main unit. There are four conductive heads on the main unit, which are mainly composed of stainless steel sheets and giving users stimulation and heating functions, and help users relieve knee pain. The stimulation and heating functions can happen simultaneously or independently by control the button on the main unit. When in use, the main unit is fixed with a bandage, and the electrode sheet is placed at the relevant treatment site according to the instructions. The electrode pads can be used on the guidance site for stimulation only when connected to the host. There are two models of the device, which differ only in appearance.
The electrode pads are complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are interchangeable.
5. Intended Use / Indications for Use
TENS:
5
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.
It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
PMS:
It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.
Heating:
lt is intended for temporary relief of minor aches and pains.
6. Test Summary
6.1 Non-clinical testing was conducted to verify that the subject device met all design specifications, demonstrated safety based on current industry standards, and to demonstrate substantial equivalence to the predicate. The following tests were performed:
Low-frequency 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 10993-5 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
6.2 Summary of Clinical Performance Test
No clinical study is included in this submission.
7. Comparison to predicate device and conclusion
The technological characteristics, features, specifications, materials, Mode of operation, and intended use of Low-frequency stimulator 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 | Secondary Predicate
Device | Remark | |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|--------------|
| Device Name | Low-frequency stimulator
(Model: AST-645, AST-646) | JKH Stimulator Plus | Health Expert Electronic
Stimulator
Model: AST-300L | -- | |
| 510(k) Number | K212989 | K191151 | K190783 | -- | |
| Elements of
Comparison | Subject Device | Primary Predicate Device | Secondary Predicate
Device | Remark | |
| Intended Use | 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.
It is also intended for
symptomatic relief and
management of chronic,
intractable pain and relief
of pain associated with
arthritis.
PMS:
It is intended to stimulate
healthy muscles in order
to improve and facilitate
muscle performance.
Heating:
It is intended for
temporary relief of minor
aches and pains. | TENS:
PL-029K5BL, PL-029K15,
and PL-029T are used for
temporary relief of pain
associated with sore and
aching muscles in the
shoulder, waist, back, arm,
and leg, due to strain from
exercise or normal
household and work
activities.
PL-029K5BL, PL-029K15,
and PL-029T are also
intended for symptomatic
relief and management of
chronic, intractable pain
and relief of pain
associated with arthritis.
The device of PL-029K5BL
and PL-029K15 may be
used during sleep. The
device of PL- 029K5BL and
PL-029K15 is labeled for
use only with its own
compatible electrodes.
PMS:
PL-029K5BL, PL-029K15,
and PL-029T are used to
stimulate healthy muscles
in order to improve and
facilitate muscle
performance. To be used
for the improvement of
muscle tone and firmness,
and for strengthening
muscles in the arms,
abdomen, legs, and
buttocks. Not intended for
use in any therapy or for
the treatment of any
medical conditions or
diseases.
PL-029K5BL, PL-029K15,
and PL-029T are also
intended to temporarily
increase local blood
circulation in the healthy
muscles of lower
extremities.
Heating: | PMS (Mode 18)25)
It is intended to stimulate
healthy muscles in order
to improve and facilitate
muscle performance.
TENS (Mode 9
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. | SE | |
| Elements of
Comparison | Subject Device | Primary Predicate Device | Secondary Predicate
Device | Remark | |
| | | | The device of PL-029T is
intended for temporary
relief of minor aches and
pains. | | |
| Power Source(s) | | Powered by adapter,
100-240VAC, 50-60Hz
Output: 9Vdc, 2A
Unit Input: 9Vdc, 2A | Rechargeable or non-
rechargeable battery | Adaptor Input:
100-240Vac, 50-60Hz,
0.1A
Output: 5Vdc, 2A
Unit Input: 5Vdc, 2A | SE
Note 1 |
| -Method of Line
Current Isolation | | Type BF Applied Part | Battery Supply | Type BF Applied Part | SE |
| -Patient
Leakage
Current | NC | DC: