(441 days)
Not Found
No
The description focuses on low frequency electrotherapy and circular traction vibration, with no mention of AI or ML capabilities. The device operates based on pre-set modes and intensity levels controlled by the user.
Yes.
The device's intended use and description explicitly state its purpose is to provide "temporary relief of pain associated with sore and aching muscles," which aligns with the definition of a therapeutic device.
No
The device is described as a "multifunctional device" that uses low-frequency electrotherapy and circular traction vibration for "temporary relief of pain associated with sore and aching muscles." Its indicated use is for "temporary relief of pain," not for diagnosing conditions.
No
The device description explicitly mentions hardware components such as electrode pads, electrode wire, a main unit, a remote control, and an LCD display screen. It also describes physical mechanisms like low frequency electrotherapy and circular traction vibration. While software is mentioned for verification and validation, the device is clearly a combination of hardware and software.
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 uses low frequency electrotherapy and circular traction vibration to alleviate pain. It applies electrical pulses to the skin. This is a physical therapy modality, not a method for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
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 fit that description. It is a therapeutic device for pain relief.
N/A
Intended Use / Indications for Use
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of neck, back, arm, and leg, due to strain from exercise or normal household and work activities.
- Neck Pad is used in back of neck.
- Meridian Pad is used in shoulder, waist, back, and arm.
Product codes
NUH, NGX
Device Description
This instrument is a new generation of household multifunctional device based on physics, modern microelectronics and clinical practices, it uses low frequency electrotherapy, and circular traction vibration to temporarily alleviate the pain associated with sore and aching muscles in the shoulder, waist, back of neck, back, arm, and leg. The Neck Pad is used in for back of neck and it accord with human body cervical physiological curvature of streamlined ring design accord with human body cervical physiological curvature of streamlined ring design. The Meridian Pad is used in shoulder, waist, back, and arm. The device has one operation modes which has 2 modes and 50 output Intensity Level, so the device can give certain electrical pulse through 2 pairs of electrode pads or the Neck Pad on the skin to help users to enjoy body massage and sole massage.
The remote control of this device is user-friendly controlled because it has the operating elements of ON/OFF knob, left or right button and increase or decrease button.
The device is equipped with accessories of electrode pads and an electrode wire is used to connect the pads to the main unit.
The LCD display screen can show selected mode, output intensity of body and/or sole, and time remaining of an application mode.
The device can be successfully opened only when switch button of the remote control and Neck Pad turned on at the same time.
The remote control is the only controller to select the pulse intensity and adjust the treatment time.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, waist, back of neck, back, arm, and 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)
Neck Care Therapy, Model: AST-905B 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
- Usability test according to IEC 62366 standard
- Software verification and validation test according to the requirements of the FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
- The waveform test 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
December 7, 2018
Shenzhen OSTO Technology Co., Ltd. % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road Guangzhou Science Park Guangzhou, 510006 China
Re: K172897
Trade/Device Name: Neck Care Therapy, Model: SYK-509B Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: November 2, 2018 Received: November 8, 2018
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.
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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Pamela D. Scott -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172897
Device Name Neck Care Therapy (model: 905B)
Indications for Use (Describe)
To be 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.
- -Neck Pad is used in back of neck.
- Meridian Pad is used in shoulder, waist, back, and arm. -
Type of Use (Select one or both, as applicable)
| Research Use Only (RUO) unless Subject to Other Claims | |
|---|---|
| In-Vitro Diagnostic Use (IVD) unless Subject to Other Claims |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | 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 K172897
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 Co., Ltd. Establishment Registration Number: Applying 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 Manager) Email: annaosto@163.com
Application Correspondent:
Contact Person: Ms. Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Address: Suite 306, Kecheng Mansion, No.121 Science Road, Guangzhou Science Park, Guangzhou 510663, China Tel: +86-20-61099984 Email: requlatory@glomed-info.com
2. Subject Device Information
Trade Name: Neck Care Therapy Common Name: Electronic Stimulator Classification name: Transcutaneous electrical nerve stimulator for pain relief, Transcutaneous Electrical Nerve Stimulator, Muscle, Powered, For Muscle Conditioning Review Panel: Neurology Product Code: NUH, NGX Regulation Class: II Regulation Number: 21 CFR 882.5890, 890.5850
3. Predicate Device Information
Sponsor: Shenzhen OSTO Technology Company Limited Trade Name: Health Expert Electronic Stimulator Common Name: Electronic Stimulator Classification name: Stimulator, Nerve, Transcutaneous, Muscle, Powered, For Muscle Conditioning, Over-The-Counter 510(k)number: K133929 Review Panel: Neurology, Physical Medicine Product Code: NUH, NGX Regulation Number: 882.5890, 890.5850 Regulation Class: II
4
4. Device Description
This instrument is a new generation of household multifunctional device based on physics, modern microelectronics and clinical practices, it uses low frequency electrotherapy, and circular traction vibration to temporarily alleviate the pain associated with sore and aching muscles in the shoulder, waist, back of neck, back, arm, and leg. The Neck Pad is used in for back of neck and it accord with human body cervical physiological curvature of streamlined ring design accord with human body cervical physiological curvature of streamlined ring design. The Meridian Pad is used in shoulder, waist, back, and arm. The device has one operation modes which has 2 modes and 50 output Intensity Level, so the device can give certain electrical pulse through 2 pairs of electrode pads or the Neck Pad on the skin to help users to enjoy body massage and sole massage.
The remote control of this device is user-friendly controlled because it has the operating elements of ON/OFF knob, left or right button and increase or decrease button.
The device is equipped with accessories of electrode pads and an electrode wire is used to connect the pads to the main unit.
The LCD display screen can show selected mode, output intensity of body and/or sole, and time remaining of an application mode.
The device can be successfully opened only when switch button of the remote control and Neck Pad turned on at the same time.
The remote control is the only controller to select the pulse intensity and adjust the treatment time.
5. Intended Use / Indications for Use
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of neck, back, arm, and leg, due to strain from exercise or normal household and work activities.
- Neck Pad is used in back of neck. ।
- -Meridian Pad is used in shoulder, waist, back, and arm.
6. Test Summary
Neck Care Therapy, Model: AST-905B 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
- � Usability test according to IEC 62366 standard
- � Software verification and validation test according to the requirements of the FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
- � The waveform test 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".
7. Comparison to predicate device and conclusion
5
The technological characteristics, features, specifications, materials, mode of operation, and intended use of Electronic Muscle 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
K172897 | device | Predicate
K133929 | device | Remark |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Device name and model | AST-905B
200B | Neck Care Therapy
or SYK- | Health | Expert
Electronic Stimulator | |
| Intended Use & Indications for
Use | temporary
sore
muscles
from
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | To be used for
relief
of
pain associated with
and
aching
in
the
shoulder, waist, back
of neck, back, arm,
and leg, due to strain
exercise
or
normal household and
work activities.
— Neck Pad is
used in back of neck.
Meridian Pad is
used in shoulder,
waist, back, and arm | stimulate
925)8)
To
sore
muscles
normal
work | PMS (Mode 1
It is intended to
healthy
muscles in order to
improve and facilitate
muscle performance.
TENS
(Mode
be
used
for
temporary relief
of
pain associated with
and aching
in
the
shoulder, waist, back,
back of the neck, arm,
leg, and foot due to
strain from exercise or
household
activities
by
applying current
to
stimulate nerve. | Similar intended
use and IFU |
| Power Source(s) | C, | Main Unit:
Power Adaptor:
Input:100~240Va
50/60Hz, 0.2A;
Output: 5Vdc, 1A | 100-
0.1A | Adaptor
Input:
240Vac, 50-60Hz,
Output: 5Vdc, 1A
Unit Input: 5Vdc, 1A | Similar |
| | 500mAh | Battery:
3.7Vdc, | 500mAh | Battery:
3.7Vdc, | Identical |
| | AAA x 2
1 A | Remote Control:
Battery:
3Vdc,
Unit Input: 5Vdc, | AAA x 2
1 A | Remote Control:
Battery:
3Vdc,
Unit Input: 5Vdc, | Identical |
| Current
Method
of
Line
Isolation | Part | Type BF Applied | Part | Type BF Applied | Identical |
| Patient Leakage Current | NC
SFC | AC: 54.5uA
DC: 0.5uA
AC: 120uA | NC
SFC | AC: 54.5uA
DC: 0.5uA
AC: 120.0uA | Identical |
6
| DC: 0.6uA | DC: 0.6uA | DC: 0.6uA | |
|---|---|---|---|
| Average current through | |||
| electrodes when device is on but | |||
| no pulses are being applied |