(272 days)
Not Found
No
The description focuses on standard electrical stimulation modes and controls, with no mention of adaptive algorithms, learning capabilities, or AI/ML terminology.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "temporary relief of pain" and to "stimulate healthy muscles in order to improve and facilitate muscle performance," which are therapeutic applications. Additionally, the device uses TENS and PMS technologies, both of which are forms of electrotherapy used for medical and therapeutic purposes.
No
The device description and intended use clearly state that it is a stimulator for muscle performance and pain relief, not for diagnosing medical conditions.
No
The device description explicitly states it is a "portable and adapter powered multifunctional device" and details hardware components like electrode pads, electrode wires, an adapter, a remote controller, a display screen, and operating elements. It also mentions electrical pulse delivery through these components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for stimulating healthy muscles and providing temporary relief of pain by applying electrical current to the skin. This is a therapeutic use, not a diagnostic one.
- Device Description: The description details a device that delivers electrical pulses through electrodes placed on the skin or feet. This is consistent with a physical therapy or pain relief device, not a device that analyzes biological samples (which is the core function of an IVD).
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of detecting or measuring substances within the body for diagnostic purposes.
In summary, the device's function and intended use are entirely focused on applying external electrical stimulation for therapeutic benefits, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 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
NUH, NGX
Device Description
Health Expert Electronic Stimulator is a portable and adapter powered multifunctional device, offering both Transcutaneous Electronic Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) qualities.
Health Expert Electronic Stimulator has 25 operation modes, which can give certain electrical pulse through 4 pcs of electrode pads placed on the skin to help users to enjoy body stimulation and 2 big electrode pads in Electrode Silicon Area for feet placed on the main unit to help users to enjoy sole stimulation.
The electronic stimulatory module has the operating elements of ON/OFF Switch, Display screen, Mode Selection key and Intensity Modification keys.
The LCD display screen can show selected mode, output intensity of body and/or sole, and time remaining of an application mode.
The device is equipped with accessories of electrode wire, adapter, remote controller. The electrode wire is used to connect the pads to the main unit; the adapter wire is used to connect the adapter to the device.
The electrode pads, which are provided by Shenzhen Context Kang Technology Company Limited 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
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)
Health Expert Electronic Stimulator 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
- 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
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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December 12, 2019
Shenzhen OSTO Technology Company Limited % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. Room 2231, Building 1, Ruifeng Center, Kaichuang Road Huangpu District Guangzhou, 51006 CN
Re: K190673
Trade/Device Name: Health Expert Electronic Stimulator, Models AST-300F, AST-300H, AST-300J Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: September 7, 2019 Received: September 13, 2019
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/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 D. Scott Assistant Director 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
Enclosure
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Indications for Use
510(k) Number (if known) K190673
Device Name
Health Expert Electronic Stimulator (model: AST-300F, AST-300H, AST-300J)
Indications for Use (Describe)
PMS (Mode 1~8)
It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.
- TENS (Mode 9~25)
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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter's Information
- 510(k) Owner's Name: Shenzhen 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
- Health Expert Electronic Stimulator � Trade Name:
- Electronic Stimulator � Common Name:
- Stimulator, Nerve, Transcutaneous, Muscle, Powered, For Classification name: �
- Muscle Conditioning, Over-The-Counter
- Neurology, Physical Medicine � Review Panel:
- NUH, NGX � Product Code:
- ll � Regulation Class:
- 882.5890, 890.5850 � Regulation Number:
4. Predicate Device Information
| Sponsor | Shenzhen OSTO Technology Company Limited |
|---|---|
| Device Name and Model | Health Expert Electronic Stimulator |
| Model: AST-300C and AST-300D | |
| 510(k) Number | K133929 |
| Product Code | NUH, NGX |
| Regulation Number | 882.5890, 890.5850 |
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| Regulation Class | II |
|---|---|
| ------------------ | ---- |
2. Device Description
Health Expert Electronic Stimulator is a portable and adapter powered multifunctional device, offering both Transcutaneous Electronic Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) qualities.
Health Expert Electronic Stimulator has 25 operation modes, which can give certain electrical pulse through 4 pcs of electrode pads placed on the skin to help users to enjoy body stimulation and 2 big electrode pads in Electrode Silicon Area for feet placed on the main unit to help users to enjoy sole stimulation.
The electronic stimulatory module has the operating elements of ON/OFF Switch, Display screen, Mode Selection key and Intensity Modification keys.
The LCD display screen can show selected mode, output intensity of body and/or sole, and time remaining of an application mode.
The device is equipped with accessories of electrode wire, adapter, remote controller. The electrode wire is used to connect the pads to the main unit; the adapter wire is used to connect the adapter to the device.
The electrode pads, which are provided by Shenzhen Context Kang Technology Company Limited complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are interchangeable.
5. Intended Use / Indications for Use
PMS (Mode 1~8)
It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.
TENS (Mode 9~25)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
6. Test Summary
Health Expert Electronic Stimulator 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
- � 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
7. Comparison to predicate device and conclusion
The technological characteristics, features, specifications, mode of operation, and intended use of Electronic Muscle Stimulator is substantially equivalent to the predicate devices quoted above.
5
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 | Remark | |
|---|---|---|---|---|
| Device Name and | ||||
| Model | Health Expert Electronic | |||
| Stimulator | ||||
| Model: AST-300F, AST- | ||||
| 300H, AST-300J | Health Expert Electronic | |||
| Stimulator | ||||
| Model: AST-300C and | ||||
| AST-300D | -- | |||
| 510(k) Number | Applying | K133929 | -- | |
| Intended Use | PMS (Mode 1~8) | |||
| It is intended to stimulate | ||||
| healthy muscles in order to improve and facilitate | ||||
| muscle performance. | ||||
| TENS (Mode 9~25) | ||||
| 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. | PMS (Mode 1~8) | |||
| It is intended to stimulate | ||||
| healthy muscles in order | ||||
| to improve and facilitate | ||||
| muscle performance. | ||||
| TENS (Mode 9~25) | ||||
| 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) | Adaptor Input: 100- | |||
| 240Vac, 50-60Hz, 0.1A | ||||
| Output: 5Vdc, 1A | ||||
| Unit Input: 5Vdc, 1A | Adaptor Input: 100- | |||
| 240Vac, 50-60Hz, 0.1A | ||||
| Output: 5Vdc, 1A | ||||
| Unit Input: 5Vdc, 1A | SE | |||
| -Method of Line | ||||
| Current Isolation | Type BF Applied Part | Type BF Applied Part | SE | |
| Patient | ||||
| Leakage | ||||
| Current | NC | AC: 54.5μA, DC: 0.5μA | AC: 54.5μA, | |
| DC: 0.5μA | SE | |||
| SFC | AC:120.0μΑ, DC: 0.6μΑ | AC:120.0μA, DC: 0.6μΑ | SE | |
| Average DC | ||||
| current through | ||||
| electrodes when | ||||
| device is on but | ||||
| no pulses are | ||||
| being applied |