(353 days)
Not Found
No
The description details a standard TENS/PMS device with various modes and controls, but there is no mention of AI or ML in the device description, intended use, or performance studies. The software verification and validation are standard for medical devices and do not indicate AI/ML.
Yes
The device is intended for therapeutic uses as it aims to stimulate healthy muscles to improve performance and relieve pain associated with sore and aching muscles. These are direct therapeutic benefits.
No
The device is described as a stimulator intended to improve muscle performance and provide temporary pain relief, which are therapeutic functions, not diagnostic ones.
No
The device description explicitly details hardware components such as electrode pads, electrode wires, an adapter, a remote controller, a display screen, and physical operating elements (ON/OFF switch, keys). It also mentions electrical pulse delivery and heating capabilities, which are hardware functions. While software verification and validation are mentioned, this is for software contained in the medical device, not a standalone software-only device.
No, 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 an "Electronic Stimulator" that applies electrical pulses to the skin to stimulate muscles and nerves for pain relief and muscle performance improvement. It does not involve testing any samples taken from the body.
- Intended Use: The intended use is for stimulating healthy muscles and providing temporary pain relief, which are therapeutic and physical therapy applications, not diagnostic ones.
- Device Description: The description focuses on the electrical stimulation capabilities, electrode pads, and controls, all of which are consistent with a physical therapy or pain management device, not an IVD.
- Performance Studies: The performance studies listed are related to electrical safety, electromagnetic compatibility, biocompatibility, usability, and software verification, which are typical for medical devices that interact with the body externally, not for devices that analyze biological samples.
Therefore, based on the provided information, the Health Expert Electronic Stimulator is a therapeutic medical device, not 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, 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
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, remote control ON/OFF key, Display screen, Heating adjust key, 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 Heating adjust key can help user to select a temperature for warming sensation of the foot range 30 to 40 degree C, the superficial heating time is same as the treatment time you selected. The superficial heating and electrical stimulation can apply simultaneously or apply alternatively. The device is equipped with accessories of electrode wire, adapter, remote controller. The electrode wire is used to connect 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. Healthy muscles.
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, 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): 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.
Not Found
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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and 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.
March 14, 2020
Shenzhen OSTO Technology Company Limited % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. Room 2231, Building 1, Rui Feng Center, Kaichuang Road Huangpu District, Guangzhou Guangdong. 51006 China
Re: K190783
Trade/Device Name: Health Expert Electronic Stimulator (model: AST-300L) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: February 7, 2020 Received: February 10, 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 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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 mediation-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.
For Vivek Pinto, PhD 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
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Indications for Use
510(k) Number (if known) K190783
Device Name
Health Expert Electronic Stimulator (model: AST-300L)
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.
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, HuangpuDistrict, Guangzhou, � Guangdong, China
- � Tel: +86 20 8266 2446
- Email: requlatory@glomed-info.com �
3. Subject Device Information
- Health Expert Electronic Stimulator (model: AST-300L) � Trade Name:
- Common Name: Transcutaneous electrical nerve stimulator for pain relief �
- Stimulator, Nerve, Transcutaneous, Over-the-Counter � Classification name:
- Neurology, Physical Medicine � Review Panel:
- NUH, NGX Product Code: �
- Regulation Class: ll �
- Regulation Number: 882.5890, 890.5850 �
2. Predicate Device Information
Predicate Device 1:
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510(K) Number: K133929
Company Name: Shenzhen OSTO Technology Company Limited
Trade Name: Health Expert Electronic Stimulator
Model: AST-300C and AST-300D
Common Name: Transcutaneous electrical nerve stimulator for pain relief
Regulation Number: 882.5890, 890.5850
Regulatory Class: II
Product Code: NUH, NGX
Use: Over-The-Counter Use
Predicate Device 2:
510(K) Number: K160115 Company Name: Omron Healthcare, Inc. Trade Name: Heat Pain Pro Common Name: Transcutaneous electrical nerve stimulator for pain relief Regulation Number: 882.5890 Regulatory Class: II Product Code: NUH Use: Over-The-Counter Use
3. 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
5
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, remote control ON/OFF key, Display screen, Heating adjust key, 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 Heating adjust key can help user to select a temperature for warming sensation of the foot range 30 to 40 degree C, the superficial heating time is same as the treatment time you selected. The superficial heating and electrical stimulation can apply simultaneously or apply alternatively. The device is equipped with accessories of electrode wire, adapter, remote controller. The electrode wire is used to connect 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.
4. 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.
5. 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, 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"
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- � 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. Comparison to predicate device and conclusion
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 Device | Predicate Device 1 | Predicate Device 2 | Remark | |
|---|---|---|---|---|---|
| Device Name and | |||||
| Model | Health Expert Electronic | ||||
| Stimulator | |||||
| Model: AST-300L | Health Expert Electronic | ||||
| Stimulator | |||||
| Model: AST-300C and | |||||
| AST-300D | Heat Pain Pro | -- | |||
| 510(k) Number | K190783 | K133929 | K160115 | -- | |
| 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 | 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 | The Heat Pain Prois | ||||
| intended for: | |||||
| The relief of pain | |||||
| associated with sore or | |||||
| aching, muscles of the | |||||
| lower back, arms, legs, | |||||
| shoulder, or foot due to | |||||
| strain from exercise or | |||||
| normal household work | |||||
| activities. | SE | ||||
| Elements of | |||||
| Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark | |
| current to stimulate nerve. | current to stimulate nerve. | ||||
| Power Source(s) | Adaptor Input: | ||||
| 100-240Vac, 50-60Hz, | |||||
| 0.1A | |||||
| Output: 5Vdc, 2A | |||||
| Unit Input: 5Vdc, 2A | Adaptor Input: | ||||
| 100-240Vac, 50-60Hz, | |||||
| 0.1A | |||||
| Output: 5Vdc, 1A | |||||
| Unit Input: 5Vdc, 1A | External supply | ||||
| Lithium-ion battery | |||||
| AC adaptor/ | |||||
| Rechargeable battery | |||||
| (Lithium Ion) | SE | ||||
| Note 1 | |||||
| -Method of Line | |||||
| Current Isolation | Type BF Applied Part | Type BF Applied Part | Type BF Applied Part | SE | |
| Patient | |||||
| Leakage | NC | AC: 54.5µA, DC: 0.5µA | AC: 54.5µA, | ||
| DC: 0.5µA | 1 µA | SE | |||
| Current | SFC | AC:120.0µA, DC: 0.6µA | AC:120.0µA, DC: 0.6µA | 5.25µA max | SE |
| Average DC | |||||
| current through | |||||
| electrodes when | |||||
| device is on but | |||||
| no pulses are | |||||
| being applied |