(324 days)
PMS (Mode 18)25)
It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.
TENS (Mode 9
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
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, as well as certain non-electrical rolling massage through one massage roller.
The electronic stimulatory module has the operating elements of ON/OFF Switch, Display screen, Mode Selection key and Intensity Modification keys.
The LCD display screen can show selected mode, output intensity of body and/or sole, and time remaining of an application mode.
The device is equipped with accessories of electrode wire, adapter, remote controller. The electrode wire is used to connect the pads to the main unit; the adapter wire is used to connect the adapter to the device.
The electrode pads, which are provided by Shenzhen Context Kang Technology Company Limited complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are interchangeable.
Here's a breakdown of the acceptance criteria and study information for the Health Expert Electronic Stimulator, Model AST-300C and AST-300D, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly define "acceptance criteria" as a pass/fail threshold for specific metrics. Instead, it demonstrates substantial equivalence to predicate devices by showing that the subject device's performance aligns with relevant safety and performance standards (IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2, ISO 10993-5, ISO 10993-10, IEC 62366) and FDA guidance documents.
The table below summarizes the device's technical specifications and compares them to the predicate devices, highlighting where the subject device "complies" with the established standards and guidance, which effectively serves as its acceptance criteria. "SE" in the remarks column generally means "Substantially Equivalent," implying the feature meets the necessary criteria for equivalence.
| Elements of Comparison | Acceptance Criteria (Predicate / Standard Adherence) | Reported Device Performance (Subject Device) |
|---|---|---|
| Intended Use & Indications for Use | Matches predicate devices for PMS and TENS. | PMS (Mode 1 |
| Power Source(s) | Complies with IEC 60601-1 requirements. | Adaptor Input: 100-240Vac, 50-60Hz, 0.1A; Output: 5Vdc, 1A; Unit Input: 5Vdc, 1A |
| Method of Line Current Isolation | Type BF Applied Part. | Type BF Applied Part |
| Patient Leakage Current | Complies with IEC 60601-1 requirements (predicate value: 2.0µA). | NC AC: 54.5µA, DC: 0.5µA; SFC AC: 120.0µA, DC: 0.6µA |
| Average current through electrodes when device is on but no pulses are being applied | Complies with IEC 60601-1 requirements (predicate value: < 0.01µA). | DC < 0.01µA |
| Number of Output Channels | 2 (matching predicate). | 2 |
| Number of Output Modes | Complies with IEC 60601-1 and IEC 60601-2-10 requirements (predicate: 6 or 8). | 25 |
| Output Intensity Level | Complies with IEC 60601-1 and IEC 60601-2-10 requirements (predicate: 20 steps). | 99 steps |
| Synchronous or Alternating? | Synchronous or Alternating allowed (predicate: Synchronous or Alternating). | Synchronous |
| Method of Channel Isolation | Complies with IEC 60601-1 and IEC 60601-2-10 requirements (predicate: Voltage Isolation, Transform By software). | Voltage Transform Isolation, "BODY▼" and "BODY▼" for body, "SOLE▲" and "SOLE▼" for feet. |
| Regulated Current or Regulated Voltage? | Voltage Control (matching predicate). | Voltage Control |
| Software/Firmware/Microprocessor Control? | Yes (matching predicate). | Yes |
| Automatic Overload Trip | No (matching predicate). | No |
| Automatic Load Trip | No (matching predicate). | No |
| Automatic Shut Off | Yes (matching predicate). | Yes |
| User Override Control | Yes (matching predicate). | Yes |
| Indicator On/Off Display Status | Yes (matching predicate). | Yes |
| Low Battery | No (matching predicate). | No |
| Voltage/Current Level | Yes (matching predicate). | Yes |
| Timer Range | Complies with IEC 60601-1 and IEC 60601-2-10 requirements (predicate: 10-60 minutes). | 25min |
| Weight | Complies with IEC 60601-1 and IEC 60601-2-10 requirements (predicate: 0.18Kg). | 2Kg (Without accessories) |
| Dimensions | Complies with IEC 60601-1 and IEC 60601-2-10 requirements (predicate: various). | 428mm x 428.8mm x 185mm |
| Housing Materials and Construction | ABS plastic (matching predicate). | Main unit: ABS plastic |
| Waveform | Pulsed, symmetric, biphasic (or Monophasic for one predicate). | Pulsed, symmetric, biphasic |
| Shape | Rectangular, with interphase interval (or Rectangular). | Rectangular, with interphase interval |
| Maximum Output Voltage | Complies with IEC 60601-1, IEC 60601-2-10, and FDA guidance. | 44V±10% @ 500Ω; 80V±10% @ 2KΩ; 112V±10% @ 10KΩ |
| Maximum Output Current | Complies with IEC 60601-1, IEC 60601-2-10, and FDA guidance. | 88mA±10% @ 500Ω; 40mA±10% @ 2KΩ; 11.2mA±10% @ 10KΩ |
| Pulse Duration | Complies with IEC 60601-1, IEC 60601-2-10, and FDA guidance. | 120µs |
| Pulse Frequency | Complies with IEC 60601-1, IEC 60601-2-10, and FDA guidance. | 77.3Hz |
| Net Charge (per pulse) | Complies with IEC 60601-1, IEC 60601-2-10, and FDA guidance (predicate: 0µC or 18000µC). | 0µC @ 500Ω; Method: Balanced waveform |
| Maximum Phase Charge | Complies with IEC 60601-1, IEC 60601-2-10, and FDA guidance. | 12.78µC @ 500Ω |
| Maximum Average Current | Complies with IEC 60601-1, IEC 60601-2-10, and FDA guidance. | 0.968mA @ 500Ω |
| Maximum Current Density (r.m.s) | Complies with IEC 60601-1, IEC 60601-2-10, and FDA guidance. | 0.235mA/cm² @ 500Ω |
| Maximum Average Power Density | Complies with IEC 60601-1, IEC 60601-2-10, and FDA guidance. | 1.38mW/cm² @ 500Ω |
| ON Time | Complies with IEC 60601-1, IEC 60601-2-10, and FDA guidance. | 0.6s |
| OFF Time | Complies with IEC 60601-1, IEC 60601-2-10, and FDA guidance. | 0.6s |
| Environment for operating | Complies with IEC 60601-1 requirements. | Temperature: 5 ~ 45°C; Humidity: 20 ~ 65% RH |
| Environment for storage | Complies with IEC 60601-1 requirements. | Temperature: 0 ~ 45°C, Humidity: 10 ~ 90% RH; Electrode Pad: 10~20°C |
| Biocompatibility | Compliance with ISO 10993-5 and ISO 10993-10 requirements. | All user directly contacting materials are compliance with ISO 10993-5 and ISO 10993-10 requirements. |
| Electrical Safety | Compliance with IEC 60601-1 and IEC 60601-2-10. | Comply with IEC 60601-1 and IEC 60601-2-10 |
| EMC | Compliance with IEC 60601-1-2. | Comply with IEC 60601-1-2 |
2. Sample Size Used for the Test Set and Data Provenance
The document describes lab bench testing for safety and performance. This implies the test "set" consists of the device prototypes themselves, rather than a dataset of patient information.
- Sample Size: Not applicable in the context of a dataset. The tests were performed on the device models (AST-300C and AST-300D).
- Data Provenance: The testing appears to have been conducted by Shenzhen OSTO Technology Company Limited, likely in China, as indicated by the company's address. The data is prospective in the sense that the tests were performed specifically for this 510(k) submission to demonstrate compliance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This section is not applicable (N/A) as the submission details engineering and electrical safety testing, not a clinical study involving subjective interpretation of patient data by experts. The "ground truth" for these tests is defined by international standards (IEC, ISO) and FDA guidance documents.
4. Adjudication Method for the Test Set
N/A. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret data (e.g., medical images) to establish a consensus "ground truth" when a definitive objective truth (like pathology) is unavailable. This document reports on objective engineering and performance tests, not subjective interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study would compare human reader performance with and without AI assistance, which is irrelevant for an electronic stimulator device that is not an AI/imaging diagnostic tool.
6. Standalone Performance Study
Yes, the studies conducted were essentially standalone performance studies of the device based on engineering and safety standards. The document states:
- "Health Expert Electronic Stimulator has been evaluated the safety and performance by lab bench testing..."
- The tests include electrical safety, electromagnetic compatibility, biocompatibility, usability, software verification and validation, and waveform tests.
These are all tests of the device itself, without human interaction in a clinical diagnostic context as one might find with an AI-driven image analysis tool.
7. Type of Ground Truth Used for the Test Set
The ground truth for the device's acceptable performance is defined by:
- International Standards: IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2, ISO 10993-5, ISO 10993-10, IEC 62366.
- FDA Guidance Documents: "Guidance for Pre Market Submissions and for Software Contained in Medical Devices," "Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use," and "Guidance for Powered Muscle Stimulator for Muscle Conditioning."
Performance metrics (e.g., leakage current, output voltage, pulse frequency) are compared against the limits or requirements specified in these standards and guidance documents.
8. Sample Size for the Training Set
N/A. This device is an electronic stimulator, not an AI or machine learning model that requires a "training set" of data. The device's functionality is based on direct electrical engineering principles and fixed programming, not learned behavior from a dataset.
9. How the Ground Truth for the Training Set Was Established
N/A, as there is no training set for this type of device.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are drawn with thick, curved lines, creating a sense of depth and connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 12, 2014
Shenzhen OSTO Technology Company Limited Li Yang, General Manager No.43 Longfeng Road Xinsheng Community, Longgang Street Longgang District, Shenzhen City Guangdong Province CHINA
Re: K133929
Trade/Device Name: Health Expert Electronic Stimulator, Model AST-300C and AST-300D Regulation Number: 21 CFR 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator Regulatory Class: Class II Product Code: NUH, NGX Dated: October 07, 2014 Received: October 10, 2014
Dear LiYang:
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. The general controls provisions of the Act include requirements for annual registration. Isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal 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 (reporting of medical
{1}------------------------------------------------
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Felipe Aquel -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
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Indications for Use
510(k) Number (if known) K133929
Device Name
Health Expert Electronic Stimulator, Model: AST-300C and AST-300D
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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| Sponsor: | Shenzhen OSTO Technology Company Limited |
|---|---|
| Subject Device: | Health Expert Electronic Stimulator, Model: AST-300C and AST-300D |
| File No.: | 510(k) submission report (V1.0) |
| Chapter 5 | 510(k) Summary |
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 Company Limited �
- 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 Manger) �
- Email: annaosto@163.com �
Subject Device Information 2.
-
Health Expert Electronic Stimulator � Trade Name:
ll -
Electronic Stimulator Common Name: �
-
Stimulator, Nerve, Transcutaneous, Muscle, Powered, For � Classification name: Muscle Conditioning, Over-The-Counter
-
Neurology, Physical Medicine � Review Panel:
-
NUH, NGX � Product Code:
-
Regulation Class: �
-
882.5890, 890.5850 Requlation Number: �
Predicate Device Information 3.
| Sponsor | Hong Qiangxing (Shenzhen) Electronics Limited | Prospera Cprporation |
|---|---|---|
| Device Name and Model | SM TENS & PMSModel: SM9128 | Prospera OTC TENS Electronic Pulse MassagerModel: PL029 |
| 510(k) Number | K121719 | K122744 |
| Product Code | NUH, NGX | NUH, NGX |
| Regulation Number | 882.5890, 890.5850 | 882.5890 |
| Regulation Class | II | II |
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| Sponsor: | Shenzhen OSTO Technology Company Limited |
|---|---|
| Subject Device: | Health Expert Electronic Stimulator, Model: AST-300C and AST-300D |
| File No.: | 510(k) submission report (V1.0) |
| Chapter 5 | 510(k) Summary |
4. 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, as well as certain non-electrical rolling massage through one massage roller.
The electronic stimulatory module has the operating elements of ON/OFF Switch, Display screen, Mode Selection key and Intensity Modification keys.
The LCD display screen can show selected mode, output intensity of body and/or sole, and time remaining of an application mode.
The device is equipped with accessories of electrode wire, adapter, remote controller. The electrode wire is used to connect the pads to the main unit; the adapter wire is used to connect the adapter to the device.
The electrode pads, which are provided by Shenzhen Context Kang Technology Company Limited complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are interchangeable.
5. Intended Use / Indications for Use
PMS (Mode 1~8)
It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. TENS (Mode 9~25)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist. back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
6. Test Summary
Health Expert Electronic Stimulator has been evaluated the safety and performance by lab bench testing as following:
- � Electrical safety test according to IEC 60601-1 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 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
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| Sponsor: | Shenzhen OSTO Technology Company Limited |
|---|---|
| Subject Device: | Health Expert Electronic Stimulator, Model: AST-300C and AST-300D |
| File No.: | 510(k) submission report (V1.0) |
| Chapter 5 | 510(k) Summary |
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 new issues of safety or effectiveness.
| Elements ofComparison | Subject Device | Predicate Device | Remark | |
|---|---|---|---|---|
| Device Name andModel | Health Expert ElectronicStimulatorModel: AST-300C andAST-300D | SM TENS & PMSModel: SM9128 | Prospera OTC TENSElectronic PulseMassagerModel: PL029 | -- |
| 510(k) Number | Applying | K121719 | K122744 | -- |
| Intended Use &Indications forUse | PMS (Mode 1 | TENS (Mode 1, 3, 4, 5, 6):To be used for temporaryrelief of pain associatedwith sore and achingmuscle in the shoulder,waist, back, neck, upperextremities (arm), andlower extremities (legs)due to strain fromexercise or normalhousehold work activities.PMS (Mode 1, 2, 3, 6):It is intended to be used tostimulate healthy musclein order to improve andfacilitate muscleperformance. | To be used fortemporary relief of painassociated with soreand aching muscle inthe shoulder, waist,back, neck, upperextremities (arm), andlower extremities (legs)due to strain fromexercise or normalhousehold workactivities. | SE |
| Basic Unit Characteristics | ||||
| Power Source(s) | Adaptor Input: 100-240Vac, 50-60Hz, 0.1AOutput: 5Vdc, 1AUnit Input: 5Vdc, 1A | DC 3.7V Lithium Battery | DC 3V LithiumBattery | SENote1 |
| -Method of LineCurrent Isolation | Type BF Applied Part | Type BF Applied Part | Type BF Applied Part | SE |
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| Sponsor: | Shenzhen OSTO Technology Company Limited | |
|---|---|---|
| Subject Device: | Health Expert Electronic Stimulator, Model: AST-300C and AST-300D | |
| File No.: | 510(k) submission report (V1.0) | |
| Chapter 5 | 510(k) Summary |
| Elements of Comparison | Subject Device | Predicate Device | Remark | |
|---|---|---|---|---|
| Patient Leakage Current | NC AC: 54.5µA, DC: 0.5µA | 2.0μΑ | 2.0μΑ SE Note 1 | |
| SFC AC:120.0µA, DC: 0.6μΑ | < 10μΑ | 3.3μΑ | ||
| Average current through electrodes when device is on but no pulses are being applied | DC < 0.01μA | < 0.01μA | 0μΑ SE Note 1 | |
| Number of Output Channels: | 2 | 2 | 2 SE | |
| Number of Output Modes | 25 | 6 | 8 SE Note 2 | |
| Output Intensity Level | 99 steps | 20 steps | -- SE Note 2 | |
| Synchronous or Alternating? | Synchronous | Synchronous | Alternating SE Note 2 | |
| Method of Channel Isolation | Voltage Transform Isolation"BODY▼" and"BODY▼" buttons for body channel,"SOLE▲" and"SOLE▼" buttons for feet channel | Voltage Isolation | Transform By software SE Note 2 | |
| Regulated Current or Regulated Voltage? | Voltage Control | Voltage Control | Voltage Control SE | |
| Software/Firmware/Microprocessor Control? | Yes | Yes | Yes SE | |
| Automatic Overload Trip | No | No | No SE | |
| Automatic Load Trip | No- No | No | No SE | |
| Elements ofComparison | Subject Device | Predicate Device | Remark | |
| Automatic ShutOff | Yes. | -- | Yes | SE |
| User OverrideControl | Yes | Yes | Yes | SE |
| Indicator On/OffDisplay Status | Yes | Yes | Yes | SE |
| LowBattery | No | -- | No | SE |
| Voltage/CurrentLevel | Yes | Yes | -- | SE |
| Timer Range | 25min | 10-60 minutes, 10min/step | 5min, 10min | SENote 2 |
| Weight | 2Kg(Withoutaccessories) | -- | 0.18Kg | SENote 2 |
| Dimensions | 428mm x 428.8mm x185mm | -- | 707mm x 2398mm x253mm | SENote 2 |
| Housing Materialsand Construction | Main unit: ABS plastic | -- | Enclosure: ABS | SE |
| Output Specifications | ||||
| Waveform | Pulsed, symmetric,biphasic | Pulsed, symmetric,biphasic | Monophasic | SE |
| Shape | Rectangular, withinterphase interval | Rectangular, withinterphase interval | Rectangular | SE |
| Maximum OutputVoltage | 44V±10% @ 500Ω | 42V±10% @ 500Ω | 49.6V±20% @ 500Ω | SENote 3 |
| 80V±10% @ 2KΩ | 84V±10% @ 2KΩ | 99.2V±20% @ 2KΩ | ||
| 112V±10% @ 10KΩ | 130V±10% @ 10KΩ | 114V±20% @ 10KΩ | ||
| Maximum OutputCurrent | 88mA±10% @ 500Ω | 84mA±10% @ 500Ω | 18mA±20% @ 500Ω | SENote 3 |
| 40mA±10% @ 2KΩ | 42mA±10% @ 2KΩ | 3.2mA±20% @ 2KΩ | ||
| 11.2mA±10% @ 10KΩ | 13mA±10% @10KΩ | 0.6mA±20% @ 10KΩ | ||
| Pulse Duration | 120μs | 100μs | 100~200μs | SENote 3 |
| Pulse frequency | 77.3Hz | 1~110Hz | 0.5~86Hz | SENote 3 |
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Shenzhen OSTO Technology Company Limited Sponsor: Health Expert Electronic Stimulator, Model: AST-300C and AST-300D Subject Device: File No.: 510(k) submission report (V1.0) Chapter 5 510(k) Summary
{8}------------------------------------------------
| Sponsor: | Shenzhen OSTO Technology Company Limited |
|---|---|
| Subject Device: | Health Expert Electronic Stimulator, Model: AST-300C and AST-300D |
| File No.: | 510(k) submission report (V1.0) |
| Chapter 5 | 510(k) Summary |
| Elements ofComparison | Subject Device | Predicate Device | Remark | |
|---|---|---|---|---|
| Net Charge (perpulse) | 0µC @ 500ΩMethod: Balancedwaveform | 0µC @ 500Ω,Method: Balancedwaveform | 18000µC @ 500Ω | SENote 3 |
| Maximum PhaseCharge | 12.78µC @ 500Ω | 16.80µC @ 500Ω | 23.00µC @ 500Ω | SENote 3 |
| MaximumAverage Current | 0.968mA @ 500Ω | 0.924mA @ 500Ω | -- | SENote 3 |
| Maximum CurrentDensity (r.m.s ) | 0.235mA/cm² @ 500Ω | 0.462mA/cm² @500Ω | 1.4mA/cm² @500Ω | SENote 3 |
| MaximumAverage PowerDensity | 1.38mW/cm² @ 500Ω | 9.702m W/cm² @500Ω | 0.23W/cm² @ 500Ω | SENote 3 |
| ON Time | 0.6s | -- | 40ms | SENote 3 |
| OFF Time | 0.6s | -- | 18ms | SENote 3 |
| Additional Features | ||||
| Environment foroperating | Temperature: 5 ~ 45°CHumidity: 20 ~ 65% RH | Temperature: 5 ~ 40°CHumidity: ≤80% RH | -- | SENote 1 |
| Environment forstorage | Temperature: 0 ~ 45°C,Humidity: 10 ~ 90% RHElectrode Pad: 10~20°C | Temperature: -20 ~ 55°CHumidity: ≤93% RH | -- | SENote 1 |
| Standards | ||||
| Biocompatibility | All user directlycontacting materials arecompliance withISO10993-5 andISO10993-10requirements. | All user directly contactingmaterials are compliance withISO10993-5 and ISO10993-10requirements. | All user directlycontacting materialsare compliance withISO10993-5 andISO10993-10requirements. | SE |
| Electrical Safety | Comply with IEC 60601-1 and IEC 60601-2-10 | Comply with IEC 60601-1and IEC 60601-2-10 | Comply with IEC60601-1 and IEC60601-2-10 | SEIEC |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Comply with60601-1-2 | IEC SE |
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| Sponsor: | Shenzhen OSTO Technology Company Limited |
|---|---|
| Subject Device: | Health Expert Electronic Stimulator, Model: AST-300C and AST-300D |
| File No.: | 510(k) submission report (V1.0) |
| Chapter 5 | 510(k) Summary |
Comparison in Detail(s):
Note 1:
Although the " Power Source(s)", " Patient Leakage Current", "Average DC current through electrodes when device is on but no pulses are being applied", "Operating Environment" are a little different from the predicate devices, they all comply with IEC 60601-1 requirements. So the differences will not raise any safety or effectiveness issue.
Note 2:
Although the " Number of Output Modes" "Output Intensity Level", " Method of Channel Isolation", " Timer Range", "Weight" and "Dimensions" of subject device are different from the predicate devices, they 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:
Although the "Maximum Output Voltage", "Maximum Output Current", "Maximum pulse frequency", "Net Charge (per pulse)", "Maximum Phase Charge", "Maximum Average Current", "Maximum Current Density", "Maximum Average Power Density of subject device", "ON Time" and "OFF Time" are a little different from the predicate devices, they all comply with IEC 60601-1, IEC 60601-2-10 requirement, FDA quidance requirement for Transcutaneous Electrical Nerve Stimulator for Pain Relief and FDA guidance requirement for Powered Muscle Stimulator for Muscle Conditioning, So the differences of function specification will not raise any safety or effectiveness issue.
Finial Conclusion:
The subject device "Health Expert Electronic Stimulator" is Substantial Equivalent to the predicate devices.
8. Date of the summary prepared: November 1, 2014
§ 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).