(352 days)
Not Found
No
The device description and performance studies focus on electrical stimulation parameters and safety standards, with no mention of AI or ML algorithms for data analysis, decision-making, or personalized therapy.
Yes.
The device is intended to stimulate healthy muscles to improve performance and provide temporary pain relief, which are therapeutic functions.
No
The device is intended to stimulate muscles to improve performance and relieve pain, and it applies current to stimulate nerves. It does not describe any function related to diagnosing medical conditions.
No
The device description explicitly mentions hardware components such as electrode pads, electrode wire, adapter, remote controller, and a main unit with a display screen and physical keys. The performance studies also include electrical safety, electromagnetic compatibility, and biocompatibility testing, which are relevant to hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes stimulating muscles and relieving pain through electrical stimulation applied to the body. This is a therapeutic function, not a diagnostic one.
- Device Description: The description details a device that delivers electrical pulses to the skin via electrode pads for muscle stimulation and pain relief. This aligns with a physical therapy or pain management device, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions based on such analysis, or providing information for diagnosis.
The device falls under the category of a therapeutic medical device, specifically a powered muscle stimulator (PMS) and a transcutaneous electrical nerve stimulator (TENS). The predicate device listed (K133929) is also described as an "Electronic Stimulator," further supporting this classification.
N/A
Intended Use / Indications for Use
PMS (Mode 1) It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.
TENS (Mode 2) 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 (comma separated list FDA assigned to the subject device)
NUH, NGX
Device Description
Low-frequency Multi-function Physiotherapy Instrument is a household multifunctional device. it can stimulate healthy muscles in order to improve and facilitate muscle performance, and to relief the pain associated with sore and aching muscles in the waist, upper and lower back, back of the neck, upper extremities (shoulder, arm and hand), lower extremities (hip, knee, ankle, leg and feet) due to strain from exercise or normal household work activities by applying current to stimulate nerve.
Low-frequency Multi-function Physiotherapy Instrument has 2 operation modes and two channels, which can give certain electrical pulse through 2 pairs of electrode pads on the skin to help users to enjoy body massage and sole massage.
The electronic stimulatory module has the operating elements of ON/OFF Switch, Display screen, Mode Selection key, Intensity Modification keys and time selection 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.
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
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)
Low-frequency Multi-function physiotherapy instrument, Model: AST-603, AST-2012B 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
- 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): 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).
0
Image /page/0/Picture/0 description: The image shows 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.
September 6, 2018
Shenzhen OSTO Technology Co., Ltd. % Cecilia Ceng Manager Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road Guangzhou Science Park Guangzhou, Guangdong 510006 Cn
Re: K172834
Trade/Device Name: Low Frequency Multi Function Physiotherapy Instrument, Models AST-603, AST-2012A, AST-2010B Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: July 25, 2018 Received: August 6, 2018
Dear Cecilia Ceng:
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/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) K172834
Device Name
Low Frequency Multi-Function Physiotherapy Instrument
Indications for Use (Describe) PMS (Mode 1) It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.
TENS (Mode 2)
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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3
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 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: regulatory@glomed-info.com
2. Subject Device Information
Trade Name: Low-frequency Multi-function physiotherapy instrument Common Name: Electronic Stimulator Classification name:
-
- Stimulator, Nerve, Transcutaneous, Over-The-Counter (NUH)
- Stimulator, Muscle, Powered, For Muscle Conditioning (NGX) Review Panel: Neurology Product Code: NUH, NGX Regulation Class: II Regulation Number: 21 CFR 882.5890, 890.5850
3. Predicate Device Information
Sponser: 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 Requlation Class: II
4. Device Description
4
Low-frequency Multi-function Physiotherapy Instrument is a household multifunctional device. it can stimulate healthy muscles in order to improve and facilitate muscle performance, and to relief the pain associated with sore and aching muscles in the waist, upper and lower back, back of the neck, upper extremities (shoulder, arm and hand), lower extremities (hip, knee, ankle, leg and feet) due to strain from exercise or normal household work activities by applying current to stimulate nerve.
Low-frequency Multi-function Physiotherapy Instrument has 2 operation modes and two channels, which can give certain electrical pulse through 2 pairs of electrode pads on the skin to help users to enjoy body massage and sole massage.
The electronic stimulatory module has the operating elements of ON/OFF Switch, Display screen, Mode Selection key, Intensity Modification keys and time selection 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.
5. Intended Use / Indications for Use
PMS (Mode 1)
It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. TENS (Mode 2)
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
Low-frequency Multi-function physiotherapy instrument, Model: AST-603, AST-2012B 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
- � 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
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 of safety or effectiveness.
| Elements of
| Comparison | Subject Device | Predicate Device | Verdict | |
|---|---|---|---|---|
| Company | Shenzhen OSTO | |||
| Technology Co., Ltd | Shenzhen OSTO | |||
| Technology Co., Ltd | -- | |||
| Elements of | ||||
| Comparison | Subject Device | Predicate Device | Verdic | |
| t | ||||
| Trade Name | Low-frequency Multi- | |||
| functional physiotherapy | ||||
| instrument | Health Expert Electronic | |||
| Stimulator | -- | |||
| Classification Name | Stimulator, Nerve, | |||
| Transcutaneous, Over- | ||||
| The-Counter | Stimulator, Nerve, | |||
| Transcutaneous, Over- | ||||
| The-Counter | -- | |||
| 510(k) Number | K172834 | K133929 | -- | |
| Product Code | NUH, NGX | NUH, NGX | SE | |
| Intended Use / | ||||
| Indications for Use | PMS (Mode 1) | |||
| It is intended to | ||||
| stimulate healthy | ||||
| muscles in order to | ||||
| improve and facilitate | ||||
| muscle performance. | ||||
| TENS (Mode 2) | ||||
| 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 | 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 | ||||
| SFC: | ||||
| AC:120.0µA, DC: 0.6µA | NC: | |||
| AC: 54.5µA, DC: 0.5µA | ||||
| SFC: | ||||
| AC:120.0µA, DC: 0.6µA | SE | |||
| Main Unit Weight | 115 g | 2 kg | SE | |
| Note 1 | ||||
| Main Unit Dimension | 128.6 x 69.8 x 25 mm | 428 x 428.8x 185mm | SE | |
| Note 1 | ||||
| Number of | ||||
| Output Channels: | 2 | 2 | SE | |
| Number of Output | ||||
| Modes | 2 | 25 | SE | |
| Note 2 | ||||
| Output Intensity | ||||
| Level | 99 | 99 | SE | |
| Elements of | ||||
| Comparison | Subject Device | Predicate Device | Verdic | |
| t | ||||
| Synchronous or | ||||
| Alternating? | Synchronous | Synchronous | SE | |
| Regulated Current | ||||
| or Regulated | ||||
| Voltage? | Yes | Yes | SE | |
| Software/Firmwar | ||||
| e/Microprocessor | ||||
| Control? | Yes | Yes | SE | |
| Automatic Shut | ||||
| Off | Yes | Yes | SE | |
| Indica | ||||
| tor | ||||
| Displa | ||||
| y | On/Off | |||
| Status | Yes | Yes | SE | |
| Low | ||||
| Battery | No | No | ||
| Voltage/ | ||||
| Current | ||||
| Level | Yes | Yes | ||
| Timer Range | 5-60 min | 25 min | SE | |
| Note2 | ||||
| Waveform | Pulsed, symmetric, | |||
| biphasic | Pulsed, symmetric, | |||
| biphasic | SE | |||
| Shape | Rectangular, with | |||
| interphase interval | Rectangular, with | |||
| interphase interval | SE | |||
| Maximum Output | ||||
| Voltage | 44V±10% @ 500Ω | 44V±10% @ 500Ω | SE | |
| 80V±10% @ 2KΩ | 80V±10% @ 2KΩ | |||
| 112V±10% @ 10KΩ | 112V±10% @ 10KΩ | |||
| Maximum Output | ||||
| Current | 88mA±10% @ 500Ω | 88mA±10% @ 500Ω | SE | |
| 40mA±10% @ 2KΩ | 40mA±10% @ 2KΩ | |||
| 11.2mA±10% @ 10KΩ | 11.2mA±10% @ 10KΩ | |||
| Pulse Duration | 120μs | 120μs | SE | |
| Pulse frequency | 77.3Hz | 77.3Hz | SE | |
| Charge density | 0.21µC/ cm² @ 500Ω | 0.21µC/ cm² @ 500Ω | SE | |
| Power density | 16.37μW/cm² @ 500Ω | 16.37μW/cm² @ 500Ω | SE | |
| Active surface area | 50.04cm² | 50.04cm² | SE | |
| Additional Features | ||||
| Environment for | ||||
| operation | Temperature: 5 ~ 45 | |||
| Humidity: 15% - 90% | ||||
| Atmospheric pressure | Temperature: 5 ~ 45° C | |||
| Humidity: 20 ~ 65% RH | SE | |||
| Elements of | ||||
| Comparison | Subject Device | Predicate Device | Verdic | |
| t | ||||
| range of 700 hPa to 1 060 | ||||
| hPa | ||||
| Environment for | ||||
| storage | Temperature: -25 - +70°C | |||
| Humidity: up to 90% | ||||
| Atmospheric pressure | ||||
| range of 700 hPa to 1 060 | ||||
| hPa | Temperature: 0 ~ 45° C, | |||
| Humidity: 10 ~ 90% RH | ||||
| Electrode Pad: 10~20° | ||||
| C | SE | |||
| For pads: | ||||
| Temperature:10~20°C | ||||
| Humidity: up to 90% | ||||
| Atmospheric pressure | ||||
| range of 700 hPa to 1060 | ||||
| hPa | For pads: | |||
| Temperature:10~20°C | ||||
| Humidity: up to 90% | ||||
| Atmospheric pressure | ||||
| range of 700 hPa to 1 | ||||
| 060 hPa | SE |
5
6
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Comparison in Detail(s):
Note 1 (Weight, Dimension):
These data would be different for different devices because the internal circuit design and components choosing are different, which make them have similar difference on weight, dimensions. But weight and dimensions won't affect the safety and effectiveness of the device so it can deemed as the substantially equivalence.
Note 2 (Number of Output Modes, Time Range):
The design of the time range is basing on the intended use. And according to the output specification comparing with the predicated devices, we set the default treatment time is 15min and the user could adjust the levels which could meet the requirements in the energy aspect. Thus, the subject device is actually the same as predicated ones.
Final Conclusion:
The subject device "Low-frequency Multi-function physiotherapy instrument" is Substantial Equivalent to the predicate devices.