(433 days)
Not Found
No
The description details a standard electrical stimulator with pre-set modes and manual controls, with no mention of adaptive algorithms, learning capabilities, or any terms associated with AI/ML.
Yes.
The device is intended for the temporary relief of pain and to stimulate healthy muscles to improve and facilitate muscle performance, which are therapeutic uses.
No
The device is intended to stimulate healthy muscles to improve performance (PMS mode) and provide temporary pain relief (TENS mode). Neither of these functions involves diagnosing a medical condition.
No
The device description explicitly mentions hardware components such as an electronic stimulatory module, electrode pads, electrode wire, and adapter, and the performance studies 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:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The description clearly states that this device is a physiotherapy instrument that applies electrical pulses to the skin for muscle stimulation (PMS) and pain relief (TENS). It interacts directly with the body externally.
- Lack of Specimen Analysis: There is no mention of collecting or analyzing any biological specimens from the patient.
- Intended Use: The intended uses are focused on stimulating muscles and relieving pain, not on diagnosing or monitoring conditions through the analysis of bodily fluids or tissues.
Therefore, this device falls under the category of a therapeutic or physical medicine device, not an In Vitro Diagnostic.
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
NUH, NGX
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.
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
Not Found
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)
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".
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
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.
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,
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
2
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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3
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 of
| Comparison | Subject Device | Predicate Device | Verdict | |
|---|---|---|---|---|
| Elements of | ||||
| Comparison | Subject Device | Predicate Device | Verdict | |
| Company | Shenzhen OSTO | |||
| Technology Co., Ltd | Shenzhen OSTO Technology | |||
| Co., Ltd | -- | |||
| Trade Name | Physiotherapy instrument | Health Expert Electronic | ||
| Stimulator | -- | |||
| Model | AST-2011A, AST-2011B, | |||
| AST-802B | AST-300C, AST-300D | -- | ||
| Classification | ||||
| Name | 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 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 | Normal Condition: | |||
| AC: 54.5μA, DC: 0.5μA | ||||
| Single Fault Condition: | ||||
| AC:120.0μA, DC: 0.6μA | Normal Condition: | |||
| AC: 54.5μA, DC: 0.5μA | ||||
| Single Fault Condition: | ||||
| AC:120.0μA, DC: 0.6μA | SE | |||
| Number of Output | ||||
| Modes | 2 | 25 | SE | |
| Note 2 | ||||
| Number of | ||||
| Output Channels: | 1 | 2 | SE | |
| Note 2 | ||||
| Elements of | ||||
| Comparison | Subject Device | Predicate Device | Verdict | |
| - Synchronous or | ||||
| Alternating? | N/A | Synchronous | SE | |
| Note 2 | ||||
| - Method of | ||||
| Channel Isolation | N/A | Voltage Transform | ||
| Isolation | ||||
| "BODY▼" and | ||||
| "BODY▼" buttons for | ||||
| body channel, | ||||
| "SOLE▲" and | ||||
| "SOLE▼" buttons for | ||||
| feet channel | SE | |||
| Note 2 | ||||
| Regulated Current | ||||
| or Regulated | ||||
| Voltage? | Voltage Control | Voltage Control | SE | |
| Software/Firmwar | ||||
| e/Microprocessor | ||||
| Control? | Yes | Yes | SE | |
| Automatic | ||||
| Overload Trip? | No | No | SE | |
| Automatic No-Load | ||||
| Trip? | No | No | SE | |
| Automatic Shut | ||||
| Off? | Yes | Yes | SE | |
| Patient Override | ||||
| Control? | No | No | SE | |
| Indicat | ||||
| or | ||||
| Displa | ||||
| y: | - On/Off | |||
| Status? | Yes | Yes | SE | |
| - Low | ||||
| Battery? | No | No | SE | |
| Voltage/Current | ||||
| Level? | Yes | Yes | SE | |
| Timer Range | ||||
| (minutes) | 5-15 min | 25 min | SE | |
| Note 3 | ||||
| Compliance with | ||||
| Voluntary | ||||
| Standards? | No | No | SE | |
| Elements of | ||||
| Comparison | Subject Device | Predicate Device | Verdict | |
| Compliance* with | ||||
| 21 CFR 898? | Yes | Yes | SE | |
| Main Unit Weight | 105 g | 2 kg | SE | |
| Note 1 | ||||
| Main Unit | ||||
| Dimension | AST-802B: 156.6 x 74.5 x | |||
| 17.8 mm | ||||
| AST-2011A: 157.03 X | ||||
| 72.87 X 23.89 mm | ||||
| AST-2011B: 156.6 x 74.5 | ||||
| x 17.8 mm | 428 x 428.8 x 185mm | SE | ||
| Note 1 | ||||
| Housing Materials | ||||
| and Construction | Main unit: ABS plastic | Main unit: ABS plastic | SE | |
| Output Specification | ||||
| Waveform | Pulsed, symmetric, | |||
| biphasic | Pulsed, symmetric, | |||
| biphasic | SE | |||
| Shape | Rectangular, with | |||
| interphase interval | Rectangular, with | |||
| interphase interval | SE | |||
| Maximum Output | ||||
| Voltage | 44V±10% @ 500Ω | |||
| 80V±10% @ 2KΩ | ||||
| 112V±10% @ 10KΩ | 44V±10% @ 500Ω | |||
| 80V±10% @ 2KΩ | ||||
| 112V±10% @ 10KΩ | SE | |||
| Maximum Output | ||||
| Current | 88mA±10% @ 500Ω | |||
| 40mA±10% @ 2KΩ | ||||
| 11.2mA±10% @ 10KΩ | 88mA±10% @ 500Ω | |||
| 40mA±10% @ 2KΩ | ||||
| 11.2mA±10% @ 10KΩ | SE | |||
| Pulse Duration | 120µs | 120µs | SE | |
| Pulse frequency | 77.3Hz | 77.3Hz | SE | |
| Symmetrical | ||||
| phases? | Yes | Yes | SE | |
| Phase Duration | 12.94 ms | 12.94 ms | SE | |
| Net Charge (mC | ||||
| per pulse) | 0µC @ 500Ω | |||
| Method: Balanced | ||||
| waveform | 0µC @ 500Ω | |||
| Method: Balanced waveform | SE | |||
| Maximum Phase | ||||
| Charge, (mC) | 12.78 µC @ 500Ω | 12.78 µC @ 500Ω | SE | |
| Maximum Current | ||||
| Density, (mA/cm²) | 0.235 mA/cm² @ 500Ω | 0.235 mA/cm² @ 500Ω | SE | |
| Maximum Power | ||||
| Density, (W/cm²) | 1.38 mW/cm² @ 500Ω | 1.38 mW/cm² @ 500Ω | SE | |
| Stimulation | ||||
| parameters | See attached table 1 | See attached table 1 | SE | |
| Elements of | ||||
| Comparison | Subject Device | Predicate Device | Verdict | |
| Bur | ||||
| st | ||||
| Mo | ||||
| de | Pulses per | |||
| burst | 400 | 400 | SE | |
| Bursts per | ||||
| second | 0.63 | 0.63 | SE | |
| Burst | ||||
| duration | ||||
| (seconds) | 2.588 | 2.588 | SE | |
| Duty Cycle | ||||
| [Line (b) x | ||||
| Line (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 for | ||||
| operation | Temperature: 5 ~ 45 | |||
| Humidity: 15% - 90% | ||||
| Atmospheric pressure | ||||
| range of 700 hPa to 1 060 | ||||
| hPa | Temperature: 5 ~ 45° C | |||
| Humidity: 20 ~ 65% RH | SE | |||
| Note 4 | ||||
| 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 | |||
| Note 4 |
5
6
7
8
9
| Table1 | ||||
|---|---|---|---|---|
| Output Specification | ||||
| Pulse Duration and Pulse | ||||
| Cycle | ||||
| Note: "T" means Pulse Cycle. | Note: "T" means Pulse Cycle. | |||
| Cycle of | ||||
| Mode 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 of | ||||
| Mode 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 |
10
| Peak Voltage (V) (10K Ω) | 112 V | 11.80 | 112 V | 11.80 |
|---|---|---|---|---|
| Cycle of | ||||
| Mode 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 of | ||||
| Mode 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 of | ||||
| Mode 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 of | ||||
| Mode 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 of | ||||
| Mode 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 of | ||||
| Mode 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 of | ||||
| Mode 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 of | ||||
| Mode 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 of | ||||
| Mode 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 of | ||||
| Mode 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 of | ||||
| Mode 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 of | ||||
| Mode 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 of | ||||
| Mode 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 of | ||||
| Mode 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 of | ||||
| Mode 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 of | ||||
| Mode 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 of | ||||
| Mode 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 of | ||||
| Mode 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 of | ||||
| Mode 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 of | ||||
| Mode 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 of | ||||
| Mode 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 of | ||||
| Mode 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 of | ||||
| Mode 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 |
11
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15
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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.