(88 days)
No
The description focuses on low-frequency electronic therapy and circular traction vibration, controlled by simple buttons or a remote. There is no mention of AI, ML, or any adaptive or learning capabilities.
Yes
The device is intended for the temporary relief of pain associated with sore and aching muscles, which is a therapeutic purpose.
No
This device is described as providing temporary relief of pain and stimulating muscles; it does not mention diagnosing any conditions.
No
The device description explicitly mentions a "main unit," "Meridian Pad," "Neck Pad," "remote control," "electrode pads," "electrode wire," and an "LCD display screen." These are all physical hardware components, indicating the device is not software-only. The performance studies also include electrical safety, electromagnetic compatibility, and biocompatibility testing, which are relevant to hardware devices.
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 electronic therapy and circular traction vibration, applying electrical pulses to the skin. This is a physical therapy modality, not a method for examining specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing information for the diagnosis of a disease or condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to provide pain relief through physical stimulation.
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, arm, and leg, due to strain from exercise or normal household and work activities.
- Neck Pad is used on back of neck.
- Meridian Pad is used on shoulder, waist, back, arm and leg.
Product codes
NUH
Device Description
For Model AST-905A and AST-905H:
This instrument is a new generation of a household multifunctional device based on physics, modern microelectronics and clinical practices, it uses low-frequency electronic therapy, and circular traction vibration to temporarily alleviate the pain associated with sore and aching muscles in the shoulder, waist, neck, back, arm, and leg. The main unit is used for the back of the neck and the streamlined ring design follows the physiological curvature of the human body. The Meridian Pad is used on the shoulder, waist, back, arm and leg.
The device has 2 operation modes: Stimulation and heating. The stimulation has 2 modes for stimulating, and 50 output Intensity Levels. The heating only has 1 mode for heating and 3 temperature levels. The device can give a certain electrical pulse through 2 pairs of electrode pads that are placed on the skin to help users to enjoy stimulation on the shoulder, waist, back, arm, and leg when using the individual Meridian pads or on the back of the neck when using the Neck Pad.
The remote control of this device is user-friendly controlled because it has the operating elements of the ON/OFF button. left or right button, and increase or decrease button.
The device is equipped with accessories of electrode pads and an electrode wire.
The LCD display screen can show the selected mode, the stimulation, and the time remaining of an application mode.
The device can be successfully opened only when both the switch button of the remote control and the main unit turned on.
When the device connected to the remote control, the remote control is the only controller to select the pulse modes, temperature modes, pulse intensity, temperature levels and adjust the treatment time.
For Model AST-905D:
This instrument is a new generation of a household multifunctional device based on physics, modern microelectronics and clinical practices, it uses low-frequency electronic therapy, and circular traction vibration to temporarily alleviate the pain associated with sore and aching muscles in the shoulder, waist, neck, back, arm, and leg. The main unit is used for the back of the neck and the streamlined ring design follows the physiological curvature of the human body. The Meridian Pad is used on the shoulder, waist, back, arm and leg.
The device has 2 operation modes: Stimulation and heating. The stimulation has 2 modes for stimulating, and 50 output Intensity Levels. The heating only has 1 mode for heating and 3 temperature levels. The device can give a certain electrical pulse through 2 pairs of electrode pads that are placed on the skin to help users to enjoy stimulation on the shoulder, waist, back, arm, and leg when using the individual Meridian pads or on the back of the neck when using the Neck Pad..
The user can control the device effectively by the buttons on the main unit. There are 5 operation buttons: switch button, "M" button, ""C" button and "—" button. The switch button can help user to turn on/off the device, the "M" button intended to select the "C" button intended to select the temperature mode and the "-" button and "--" button intended to increase or decrease the Intensity Levels or temperature levels.
The device is equipped with accessories of Meridian pads and an electrode wire.
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
Household
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-905A, AST-905D, AST-905H 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 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".
- Biocompatibility: The body-contacting components of this device are Electrode Pads and Neck Pad. And the Electrode Pads and Neck Pad comply with biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization) because the Electrode Pads and Neck Pad of the subject device are identical to those that had been cleared under K172897 (which clearance as K172897 on 12/07/2018) and been marketed to US market.
So. we have reason to believe that the Electrode Pads and Neck Pad are safe for the users. The Electrode Pads and Neck Pad comply with the following standards. - ISO 10993-5, Biological Evaluation of Medical Devices Part 5: Tests for In Vitro Cytotoxicity;
- ISO 10993-10, Biological Evaluation of Medical Devices Part 10: Tests for Irritation and Skin Sensitization.
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
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June 11, 2021
Shenzhen OSTO Technology Company Limited % Cassie Lee Submission Correspondent Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District. Guangzhou, Guangdong, China 510663
Re: K210756
Trade/Device Name: Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH Dated: March 10, 2021 Received: March 15, 2021
Dear Ms. 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.
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) K210756
Device Name NECK CARE THERAPY (Model: AST-905A, AST-905D, AST-905H)
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 on back of neck.
-
Meridian Pad is used on shoulder, waist, back, arm and leg.
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 of K210756
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 Manager) Email: annaosto@163.com
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
2. Subject Device Information
Common Name: Stimulator, Nerve, Transcutaneous, Over-The-Counter, Stimulator Trade Name: NECK CARE THERAPY, Model: AST-905A, AST-905D, AST-905H Classification Name: Transcutaneous electrical nerve stimulator for pain relief, Review Panel: Neurology Product Code: NUH Regulation Number: 882.5890 Regulation Class: II
3. Predicate Device Information Predicate Device 1:
510(K) Number: K172897 Company Name: Shenzhen OSTO Technology Co., Ltd. Address: No.43 Longfeng Road, Xinsheng Community, Longgang Street Longgang District, Shenzhen City Guangdong Province, CHINA Trade/Device Name: Neck Care Therapy, Models: SYK-509B Common Name: Electronic Stimulator Regulation Number: 882.5890 Regulatory Class: II Product Code: NUH
Predicate Device 2:
510(K) Number: K190783 Company Name: Shenzhen OSTO Technology Company Limited Address: No.43 Longfeng Road, Xinsheng Community, Longgang Street, Longgang District,
4
Shenzhen City, Guangdong Province, China Trade/Device Name: Health Expert Electronic Stimulator (model: AST-300L) Common Name: Transcutaneous electrical nerve stimulator for pain relief Regulation Number: 882.5890, 890.5850 Regulatory Class: II Product Code: NUH, NGX
4. Device Description
For Model AST-905A and AST-905H:
This instrument is a new generation of a household multifunctional device based on physics, modern microelectronics and clinical practices, it uses low-frequency electronic therapy, and circular traction vibration to temporarily alleviate the pain associated with sore and aching muscles in the shoulder, waist, neck, back, arm, and leg. The main unit is used for the back of the neck and the streamlined ring design follows the physiological curvature of the human body. The Meridian Pad is used on the shoulder, waist, back, arm and leg.
The device has 2 operation modes: Stimulation and heating. The stimulation has 2 modes for stimulating, and 50 output Intensity Levels. The heating only has 1 mode for heating and 3 temperature levels. The device can give a certain electrical pulse through 2 pairs of electrode pads that are placed on the skin to help users to enjoy stimulation on the shoulder, waist, back, arm, and leg when using the individual Meridian pads or on the back of the neck when using the Neck Pad.
The remote control of this device is user-friendly controlled because it has the operating elements of the ON/OFF button. left or right button, and increase or decrease button.
The device is equipped with accessories of electrode pads and an electrode wire.
The LCD display screen can show the selected mode, the stimulation, and the time remaining of an application mode.
The device can be successfully opened only when both the switch button of the remote control and the main unit turned on.
When the device connected to the remote control, the remote control is the only controller to select the pulse modes, temperature modes, pulse intensity, temperature levels and adjust the treatment time.
For Model AST-905D:
This instrument is a new generation of a household multifunctional device based on physics, modern microelectronics and clinical practices, it uses low-frequency electronic therapy, and circular traction vibration to temporarily alleviate the pain associated with sore and aching muscles in the shoulder, waist, neck, back, arm, and leg. The main unit is used for the back of the neck and the streamlined ring design follows the physiological curvature of the human body. The Meridian Pad is used on the shoulder, waist, back, arm and leg.
The device has 2 operation modes: Stimulation and heating. The stimulation has 2 modes for stimulating, and 50 output Intensity Levels. The heating only has 1 mode for heating and 3 temperature levels. The device can give a certain electrical pulse through 2 pairs of electrode pads that are placed on the skin to help users to enjoy stimulation on the shoulder, waist, back, arm, and leg when using the individual Meridian pads or on the back of the neck when using the Neck Pad..
The user can control the device effectively by the buttons on the main unit. There are 5 operation buttons: switch button, "M" button, ""C" button and "—" button. The switch button can help user to turn on/off the device, the "M" button intended to select the "C" button intended to select the temperature mode and the "-" button and "--" button intended to increase or decrease the Intensity Levels or temperature levels.
5
The device is equipped with accessories of Meridian pads and an electrode wire.
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 on back of neck.
- Meridian Pad is used on shoulder, waist, back, arm and leg.
6. Test Summary
NECK CARE THERAPY, Model: AST-905A, AST-905D, AST-905H 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 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".
- � Biocompatibility:
The body-contacting components of this device are Electrode Pads and Neck Pad. And the Electrode Pads and Neck Pad comply with biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization) because the Electrode Pads and Neck Pad of the subject device are identical to those that had been cleared under K172897 (which clearance as K172897 on 12/07/2018) and been marketed to US market.
So. we have reason to believe that the Electrode Pads and Neck Pad are safe for the users. The Electrode Pads and Neck Pad comply with the following standards.
- ISO 10993-5, Biological Evaluation of Medical Devices Part 5: Tests for In Vitro Cytotoxicity;
- ISO 10993-10, Biological Evaluation of Medical Devices Part 10: Tests for Irritation and Skin Sensitization.
7. Comparison to predicate device and conclusion
The technological characteristics, features, specifications, materials, mode of operation, and intended use of NECK CARE THERAPY (Model: AST-905A, AST-905D, AST-905H) 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 | Predicate Device 1 | Predicate Device 2 | Remark | |
|---|---|---|---|---|---|
| Device Name and | |||||
| Model | NECK CARE | ||||
| THERAPY | |||||
| Model: AST-905A, | |||||
| AST-905D and AST- | |||||
| 905H | Neck Care Therapy | ||||
| AST-905B or SYK- | |||||
| 509B | Health Expert | ||||
| Electronic | |||||
| Stimulator (model: | |||||
| AST-300L) | -- | ||||
| 510(k) Number | K210756 | K172897 | K190783 | -- | |
| 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 on
back of neck. - Meridian Pad is used
on shoulder, waist,
back, arm and leg. | 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. | 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 | |
| Power Source(s) | Main Unit: 3.7Vdc,
2200mAh lithium
battery
Power Adaptor:
Input: 100240Vac,240Vac,
50/60Hz, 0.2A;
Output: 5Vdc, 1A
Remote Control:
Battery: 3Vdc, 1.5V
AAA x 2 | Main Unit:
Power Adaptor:
Input:100
50/60Hz, 0.2A;
Output: 5Vdc, 1A
Battery: 3.7Vdc,
2200mAh
Remote Control:
Battery: 3Vdc, AAA x
2
Unit Input: 5Vdc, 1A | Adaptor Input:
100-240Vac, 50-
60Hz, 0.1A
Output: 5Vdc, 2A
Unit Input: 5Vdc, 2A | SE | |
| Method of Line
Current Isolation | Type BF Applied Part | Type BF Applied Part | Type BF Applied
Part | SE | |
| Patient
Leakage
Current | NC
SFC | AC: 54.5μA,
DC: 0.5μA
AC:120.0μA,
DC: 0.6μA | AC: 54.5μA,
DC: 0.5μA
AC:120.0μA,
DC: 0.6μA | AC: 54.5μA, DC:
0.5μA
AC: 120.0μA, DC:
0.6μA | SE |
| Average current
through electrodes
when device is on but
no pulses are being
applied | |