(433 days)
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.
Physiotherapy instrument has 2 operation modes and one channel, after insert the electrode wire of the electrode pads, just put the electrode pads on the same side of your body, for shoulder, waist, back, back of the neck, arm, leg or foot (depends on your need, please consult your doctor before using if need), which can give certain electrical pulse through 2 pieces of electrode pads on the skin.
The electronic stimulatory module has the operating elements of ON/OFF Switch, Display screen, Mode Selection key, Intensity enhancement/weakening keys, language switch button and time selection keys. The LCD display screen can show selected mode, output intensity of body and/or sole, time remaining of an application mode, language display systemy.
The device is equipped with accessories of electrode pads, electrode wire, adapter.
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 provided document is a 510(k) summary for a Low-frequency Multi-function physiotherapy instrument. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria for a new AI/ML-driven medical device.
Therefore, the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set sample size, and ground truth establishment for the training set) is not present in this document.
This document describes a traditional medical device (Physiotherapy instrument) and its submission for FDA clearance via a 510(k) pathway. The test summary mentions "lab bench testing" for electrical safety, electromagnetic compatibility, biocompatibility, usability, software verification and validation, and waveform testing, all according to established IEC and ISO standards and FDA guidance documents. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, primarily through engineering and bench testing, rather than extensive clinical studies or performance against specific AI/ML-related metrics.
In summary, this document does not contain the information required to answer the prompt, as it pertains to the clearance of a non-AI/ML medical device through predicate equivalence, not a performance study of an AI/ML device against predefined acceptance criteria.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out as "U.S. Food & Drug Administration".
November 26, 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. 510006 Cn
Re: K172837
Trade/Device Name: Low-frequency Multi-function physiotherapy instrument Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: October 17, 2018 Received: October 26, 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.
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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/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,
Timothy A. Marjenin -S
Carlos L. Peña, PhD, MS For Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172837
Device Name
Physiotherapy instrument (Models: AST- 2011A, AST- 2011B, and AST-802B)
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.
| 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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Chapter 5. 510(k) Summary
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
Type of 510(k): Traditional Trade/Device Name: Physiotherapy instrument, Models: AST-2011A, AST-2011B, AST-802B Common Name: Electronic Simulator Classification Name: 1. Stimulator. Nerve. Transcutaneous. Over-The-Counter (NUH) 2. Stimulator, Muscle, Powered, For Muscle Conditioning (NGX) Review Panel: Neurology Product Code: NUH, NGX Regulation Number: 21 CFR 882.5890, 890.5850 Regulatory Class: II
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
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Requlation Class: II
4. Device Description
Physiotherapy instrument has 2 operation modes and one channel, after insert the electrode wire of the electrode pads, just put the electrode pads on the same side of your body, for shoulder, waist, back, back of the neck, arm, leg or foot (depends on your need, please consult your doctor before using if need), which can give certain electrical pulse through 2 pieces of electrode pads on the skin.
The electronic stimulatory module has the operating elements of ON/OFF Switch, Display screen, Mode Selection key, Intensity enhancement/weakening keys, language switch button and time selection keys. The LCD display screen can show selected mode, output intensity of body and/or sole, time remaining of an application mode, language display systemy.
The device is equipped with accessories of electrode pads, electrode wire, adapter.
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
Physiotherapy instrument, Models: AST-2011B, AST-2011B, AST-802B 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 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, 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.
Comparison in Detail(s):
| Elements ofComparison | Subject Device | Predicate Device | Verdict | |
|---|---|---|---|---|
| Elements ofComparison | Subject Device | Predicate Device | Verdict | |
| Company | Shenzhen OSTOTechnology Co., Ltd | Shenzhen OSTO TechnologyCo., Ltd | -- | |
| Trade Name | Physiotherapy instrument | Health Expert ElectronicStimulator | -- | |
| Model | AST-2011A, AST-2011B,AST-802B | AST-300C, AST-300D | -- | |
| ClassificationName | Stimulator, Nerve,Transcutaneous, Over-The-Counter | Stimulator, Nerve,Transcutaneous, Over-The-Counter | -- | |
| 510(k) Number | Applying | K133929 | -- | |
| Product Code | NUH, NGX | NUH, NGX | SE | |
| Intended Use /Indications for Use | PMS (Mode 1)It is intended to stimulatehealthy muscles in orderto improve and facilitatemuscle performance.TENS (Mode 2)To be used for temporaryrelief of pain associatedwith sore and achingmuscles in the shoulder,waist,back, back of the neck,arm, leg, and foot due tostrain from exercise ornormal household workactivitiesby applying current tostimulate nerve. | PMS (Mode 1 | SE | |
| Power Source | Adaptor Input: 100-240Vac, 50-60Hz, 0.1AOutput: 5Vdc, 1AUnit Input: 5Vdc, 1A | Adaptor Input: 100-240Vac,50-60Hz, 0.1AOutput: 5Vdc, 1AUnit Input: 5Vdc, 1A | SE | |
| -Method of LineCurrent Isolation | Type BF Applied Part | Type BF Applied Part | SE | |
| PatientLeakageCurrent | Normal Condition:AC: 54.5μA, DC: 0.5μASingle Fault Condition:AC:120.0μA, DC: 0.6μA | Normal Condition:AC: 54.5μA, DC: 0.5μASingle Fault Condition:AC:120.0μA, DC: 0.6μA | SE | |
| Number of OutputModes | 2 | 25 | SENote 2 | |
| Number ofOutput Channels: | 1 | 2 | SENote 2 | |
| Elements ofComparison | Subject Device | Predicate Device | Verdict | |
| - Synchronous orAlternating? | N/A | Synchronous | SENote 2 | |
| - Method ofChannel Isolation | N/A | Voltage TransformIsolation"BODY▼" and"BODY▼" buttons forbody channel,"SOLE▲" and"SOLE▼" buttons forfeet channel | SENote 2 | |
| Regulated Currentor RegulatedVoltage? | Voltage Control | Voltage Control | SE | |
| Software/Firmware/MicroprocessorControl? | Yes | Yes | SE | |
| AutomaticOverload Trip? | No | No | SE | |
| Automatic No-LoadTrip? | No | No | SE | |
| Automatic ShutOff? | Yes | Yes | SE | |
| Patient OverrideControl? | No | No | SE | |
| IndicatorDisplay: | - On/OffStatus? | Yes | Yes | SE |
| - LowBattery? | No | No | SE | |
| Voltage/CurrentLevel? | Yes | Yes | SE | |
| Timer Range(minutes) | 5-15 min | 25 min | SENote 3 | |
| Compliance withVoluntaryStandards? | No | No | SE | |
| Elements ofComparison | Subject Device | Predicate Device | Verdict | |
| Compliance* with21 CFR 898? | Yes | Yes | SE | |
| Main Unit Weight | 105 g | 2 kg | SENote 1 | |
| Main UnitDimension | AST-802B: 156.6 x 74.5 x17.8 mmAST-2011A: 157.03 X72.87 X 23.89 mmAST-2011B: 156.6 x 74.5x 17.8 mm | 428 x 428.8 x 185mm | SENote 1 | |
| Housing Materialsand Construction | Main unit: ABS plastic | Main unit: ABS plastic | SE | |
| Output Specification | ||||
| Waveform | Pulsed, symmetric,biphasic | Pulsed, symmetric,biphasic | SE | |
| Shape | Rectangular, withinterphase interval | Rectangular, withinterphase interval | SE | |
| Maximum OutputVoltage | 44V±10% @ 500Ω80V±10% @ 2KΩ112V±10% @ 10KΩ | 44V±10% @ 500Ω80V±10% @ 2KΩ112V±10% @ 10KΩ | SE | |
| Maximum OutputCurrent | 88mA±10% @ 500Ω40mA±10% @ 2KΩ11.2mA±10% @ 10KΩ | 88mA±10% @ 500Ω40mA±10% @ 2KΩ11.2mA±10% @ 10KΩ | SE | |
| Pulse Duration | 120µs | 120µs | SE | |
| Pulse frequency | 77.3Hz | 77.3Hz | SE | |
| Symmetricalphases? | Yes | Yes | SE | |
| Phase Duration | 12.94 ms | 12.94 ms | SE | |
| Net Charge (mCper pulse) | 0µC @ 500ΩMethod: Balancedwaveform | 0µC @ 500ΩMethod: Balanced waveform | SE | |
| Maximum PhaseCharge, (mC) | 12.78 µC @ 500Ω | 12.78 µC @ 500Ω | SE | |
| Maximum CurrentDensity, (mA/cm²) | 0.235 mA/cm² @ 500Ω | 0.235 mA/cm² @ 500Ω | SE | |
| Maximum PowerDensity, (W/cm²) | 1.38 mW/cm² @ 500Ω | 1.38 mW/cm² @ 500Ω | SE | |
| Stimulationparameters | See attached table 1 | See attached table 1 | SE | |
| Elements ofComparison | Subject Device | Predicate Device | Verdict | |
| BurstMode | Pulses perburst | 400 | 400 | SE |
| Bursts persecond | 0.63 | 0.63 | SE | |
| Burstduration(seconds) | 2.588 | 2.588 | SE | |
| Duty Cycle[Line (b) xLine (c)] | 1.63 | 1.63 | SE | |
| ON Time (seconds) | 0.6s | 0.6s | SE | |
| OFF Time(seconds) | 0.6s | 0.6s | SE | |
| Additional Features | ||||
| Environment foroperation | Temperature: 5 ~ 45Humidity: 15% - 90%Atmospheric pressurerange of 700 hPa to 1 060hPa | Temperature: 5 ~ 45° CHumidity: 20 ~ 65% RH | SENote 4 | |
| Environment forstorage | Temperature: -25 - +70°CHumidity: up to 90%Atmospheric pressurerange of 700 hPa to 1 060hPa | Temperature: 0 ~ 45° C,Humidity: 10 ~ 90% RHElectrode Pad: 10~20° C | SENote 4 |
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| Table1 | ||||
|---|---|---|---|---|
| Output Specification | ||||
| Pulse Duration and PulseCycle | ||||
| Note: "T" means Pulse Cycle. | Note: "T" means Pulse Cycle. | |||
| Cycle ofMode 1 | N/A | |||
| Max | Min | |||
| Intensity | ||||
| Peak Voltage (V) (0.5KΩ) | 44 V | 0.63 | ||
| Peak Voltage (V) (2KΩ) | 80 V | 2.48 | ||
| Peak Voltage (V) (10K Ω) | 112 V | 11.80 | ||
| Cycle ofMode 2 | 200T | 200T | ||
| Intensity | Max | Min | Max | Min |
| Peak Voltage (V) (0.5KΩ) | 44 V | 0.63 | 44 V | 0.63 |
| Peak Voltage (V) (2KΩ) | 80 V | 2.48 | 80 V | 2.48 |
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| Peak Voltage (V) (10K Ω) | 112 V | 11.80 | 112 V | 11.80 |
|---|---|---|---|---|
| Cycle ofMode 3 | Image: Sub-mode 5 X 1 1s Sub-mode 6 X 2 | |||
| Intensity | N/A | Max | Min | |
| Peak Voltage (V) (0.5KΩ) | 44 V | 0.63 | ||
| Peak Voltage (V) (2KΩ) | 80 V | 2.48 | ||
| Peak Voltage (V) (10K Ω) | 112 V | 11.80 | ||
| Cycle ofMode 4 | Image: Sub-mode 6 X 1 0.5s Sub-mode 17 X 10 | |||
| Intensity | N/A | Max | Min | |
| Peak Voltage (V) (0.5KΩ) | 44 V | 0.63 | ||
| Peak Voltage (V) (2KΩ) | 80 V | 2.48 | ||
| Peak Voltage (V) (10K Ω) | 112 V | 11.80 | ||
| Cycle ofMode 5 | Image: Sub-mode 9 X 1 1s Sub-mode 15 X 10 | |||
| Intensity | N/A | Max | Min | |
| Peak Voltage (V) (0.5KΩ) | 44 V | 0.63 | ||
| Peak Voltage (V) (2KΩ) | 80 V | 2.48 | ||
| Cycle ofMode 6 | N/A | Image: Sub-mode 15 X 1 and Sub-mode 16 X 1 with 0.5s | ||
| Intensity | N/A | Max | Min | |
| Peak Voltage (V) (0.5KΩ) | N/A | 44 V | 0.63 | |
| Peak Voltage (V) (2KΩ) | N/A | 80 V | 2.48 | |
| Peak Voltage (V) (10K Ω) | N/A | 112 V | 11.80 | |
| Cycle ofMode 7 | N/A | Image: Sub-mode 5 X 1 and Sub-mode 6 X 1 with 1s | ||
| Intensity | N/A | Max | Min | |
| Peak Voltage (V) (0.5KΩ) | N/A | 44 V | 0.63 | |
| Peak Voltage (V) (2KΩ) | N/A | 80 V | 2.48 | |
| Peak Voltage (V) (10K Ω) | N/A | 112 V | 11.80 | |
| Cycle ofMode 8 | N/A | Image: Sub-mode 18 X 5 and Sub-mode 17 X 5 with 0.05s | ||
| Intensity | N/A | Max | Min | |
| Peak Voltage (V) (0.5KΩ) | N/A | 44 V | 0.63 | |
| Peak Voltage (V) (2KΩ) | N/A | 80 V | 2.48 | |
| Peak Voltage (V) (10K Ω) | N/A | 112 V | 11.80 | |
| Cycle ofMode 9 | N/A | Image: Sub-mode 11 X 5 and Sub-mode 15 X 5 with 0.3s | ||
| Intensity | Max | Min | ||
| Peak Voltage (V) (0.5KΩ) | N/A | 44 V | 0.63 | |
| Peak Voltage (V) (2KΩ) | 80 V | 2.48 | ||
| Peak Voltage (V) (10K Ω) | 112 V | 11.80 | ||
| Cycle ofMode 10 | Image: Sub-mode 8 X 1, Sub-mode 14 X 10, 0.1s | |||
| Intensity | Max | Min | ||
| Peak Voltage (V) (0.5KΩ) | N/A | 44 V | 0.63 | |
| Peak Voltage (V) (2KΩ) | 80 V | 2.48 | ||
| Peak Voltage (V) (10K Ω) | 112 V | 11.80 | ||
| Cycle ofMode 11 | Image: Sub-mode 5 X 5, Sub-mode 11 X 5, 1s | |||
| Intensity | Max | Min | ||
| Peak Voltage (V) (0.5KΩ) | N/A | 44 V | 0.63 | |
| Peak Voltage (V) (2KΩ) | 80 V | 2.48 | ||
| Peak Voltage (V) (10K Ω) | 112 V | 11.80 | ||
| Cycle ofMode 12 | Image: Sub-mode 2 X 1, Sub-mode 6 X 20, 0.5s | |||
| Intensity | Max | Min | ||
| Peak Voltage (V) (0.5KΩ) | 44 V | 0.63 | ||
| Peak Voltage (V) (2KΩ) | N/A | 80 V | 2.48 | |
| Peak Voltage (V) (10K Ω) | 112 V | 11.80 | ||
| Cycle ofMode 13 | Image: Sub-mode 11 X 1 Sub-mode 12 X 1 0.3s | |||
| Intensity | Max | Min | ||
| Peak Voltage (V) (0.5KΩ) | N/A | 44 V | 0.63 | |
| Peak Voltage (V) (2KΩ) | 80 V | 2.48 | ||
| Peak Voltage (V) (10K Ω) | 112 V | 11.80 | ||
| Cycle ofMode 14 | Image: 200T 0.5s | |||
| Intensity | N/A | Max | Min | |
| Peak Voltage (V) (0.5KΩ) | 44 V | 0.63 | ||
| Peak Voltage (V) (2KΩ) | 80 V | 2.48 | ||
| Peak Voltage (V) (10K Ω) | 112 V | 11.80 | ||
| Cycle ofMode 15 | N/A | Image: 15T 0.5s | ||
| Intensity | Max | Min | ||
| Peak Voltage (V) (0.5KΩ) | 44 V | 0.63 | ||
| Peak Voltage (V) (2KΩ) | 80 V | 2.48 | ||
| Peak Voltage (V) (10K Ω) | 112 V | 11.80 | ||
| Cycle ofMode 16 | N/A | Image: 200T 0.25s | ||
| Intensity | N/A | Max | Min | |
| Peak Voltage (V) (0.5KΩ) | 44 V | 0.63 | ||
| Peak Voltage (V) (2KΩ) | 80 V | 2.48 | ||
| Peak Voltage (V) (10K Ω) | 112 V | 11.80 | ||
| Cycle ofMode 17 | N/A | Image: 15T 0.3s | ||
| Intensity | N/A | Max | Min | |
| Peak Voltage (V) (0.5KΩ) | 44 V | 0.63 | ||
| Peak Voltage (V) (2KΩ) | 80 V | 2.48 | ||
| Peak Voltage (V) (10K Ω) | 112 V | 11.80 | ||
| Cycle ofMode 18 | N/A | Image: 200T 0.1s | ||
| Intensity | N/A | Max | Min | |
| Peak Voltage (V) (0.5KΩ) | 44 V | 0.63 | ||
| Peak Voltage (V) (2KΩ) | 80 V | 2.48 | ||
| Peak Voltage (V) (10K Ω) | 112 V | 11.80 | ||
| Cycle ofMode 19 | N/A | Image: 15T 0.15s | ||
| Intensity | Max | Min | ||
| Peak Voltage (V) (0.5KΩ) | 44 V | 0.63 | ||
| Peak Voltage (V) (2KΩ) | 80 V | 2.48 | ||
| Peak Voltage (V) (10K Ω) | 112 V | 11.80 | ||
| Cycle ofMode 20 | N/A | Image: 100T 0.5s | ||
| Intensity | Max | Min | ||
| Peak Voltage (V) (0.5KΩ) | 44 V | 0.63 | ||
| Peak Voltage (V) (2KΩ) | 80 V | 2.48 | ||
| Peak Voltage (V) (10K Ω) | 112 V | 11.80 | ||
| Cycle ofMode 21 | Image: 30T 0.05s | Image: 30T 0.05s | ||
| Intensity | Max | Min | Max | Min |
| Peak Voltage (V) (0.5KΩ) | 44 V | 0.63 | 44 V | 0.63 |
| Peak Voltage (V) (2KΩ) | 80 V | 2.48 | 80 V | 2.48 |
| Peak Voltage (V) (10K Ω) | 112 V | 11.80 | 112 V | 11.80 |
| Cycle ofMode 22 | N/A | Image: [100T 0.25s] | ||
| Intensity | N/A | Max | Min | |
| Peak Voltage (V) (0.5KΩ) | N/A | 44 V | 0.63 | |
| Peak Voltage (V) (2KΩ) | N/A | 80 V | 2.48 | |
| Peak Voltage (V) (10K Ω) | N/A | 112 V | 11.80 | |
| Cycle ofMode 23 | N/A | Image: [30T 0.3s] | ||
| Intensity | N/A | Max | Min | |
| Peak Voltage (V) (0.5KΩ) | N/A | 44 V | 0.63 | |
| Peak Voltage (V) (2KΩ) | N/A | 80 V | 2.48 | |
| Peak Voltage (V) (10K Ω) | N/A | 112 V | 11.80 | |
| Cycle ofMode 24 | N/A | Image: [100T 0.1s] | ||
| Intensity | N/A | Max | Min | |
| Peak Voltage (V) (0.5KΩ) | N/A | 44 V | 0.63 | |
| Peak Voltage (V) (2KΩ) | N/A | 80 V | 2.48 | |
| Peak Voltage (V) (10K Ω) | 112 V | 11.80 | ||
| Cycle ofMode 25 | N/A | Image: [Pulse Diagram] | ||
| Intensity | Max | Min | ||
| Peak Voltage (V) (0.5KΩ) | 44 V | 0.63 | ||
| Peak Voltage (V) (2KΩ) | 80 V | 2.48 | ||
| Peak Voltage (V) (10K Ω) | 112 V | 11.80 |
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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 deem as the substantially equivalence.
Note 2 (Number of Output Modes):
Although the "Number of Output Modes" of subject device are different from the predicate devices, thev are all comply with IEC 60601-1 and IEC 60601-2-10 requirements. So, the differences of the function specifications will not raise any safety or effectiveness issue.
Note 3 (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 is the same as predicated ones.
Note 4 (Environment for Operating and storage):
These data are to specify the condition of working, transportation and storage, for different device, the internal circuit design and components choosing are different, so they also have similar difference on working or storage conditions. But the temperature. RH are approximate and complied with the normal conditions, so it can be deemed as the substantially equivalence.
Final conclusion:
The nonclinical tests and comparation demonstrate that the subject device "Physiotherapy instrument model: AST-2011A, AST-2011B, AST-802B" is as safe, as effective, and performs as well as the predicate devices "Health Expert Electronic Stimulator AST-300C, AST-300D". So the subject device is Substantial Equivalent to predicate device K133929.
8. Date of the summary prepared: October 17. 2018
§ 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).