Dual output digital therapy massager

K172834 · Shenzhen Osto Technology Co., Ltd. · NUH · Sep 6, 2018 · Neurology

Device Facts

• Record ID: K172834
• Device Name: Dual output digital therapy massager
• Applicant: Shenzhen Osto Technology Co., Ltd.
• Product Code: NUH · Neurology
• Decision Date: Sep 6, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Household multi-function physiotherapy instrument; provides electrical muscle stimulation (PMS) and transcutaneous electrical nerve stimulation (TENS). Device features two channels; delivers electrical pulses via two pairs of electrode pads applied to skin. User interface includes LCD screen, mode selection, intensity adjustment (99 levels), and timer (5-60 min). Powered by external adapter (100-240Vac). Operated by user to facilitate muscle performance or relieve muscle pain. Output parameters (waveform, frequency, pulse duration) are fixed to ensure safety. Device includes remote controller and electrode wires. Benefits include non-invasive pain management and muscle conditioning.

Clinical Evidence

Bench testing only. Evaluated for electrical safety (IEC 60601-1-11, IEC 60601-2-10), electromagnetic compatibility (IEC 60601-1-2), biocompatibility (ISO 10993-5, ISO 10993-10), usability (IEC 62366), software validation, and waveform output verification against FDA guidance for TENS and muscle stimulators.

Technological Characteristics

Transcutaneous electrical nerve/muscle stimulator. Pulsed, symmetric, biphasic rectangular waveform with interphase interval. Pulse duration 120µs; frequency 77.3Hz. Two output channels. Type BF applied part. Powered by 5Vdc adapter. LCD display. Connectivity: wired electrode pads. Software-controlled microprocessor. Biocompatible materials per ISO 10993.

Indications for Use

Indicated for healthy individuals requiring muscle performance improvement (PMS) and temporary relief of pain in shoulder, waist, back, neck, arm, leg, and foot due to exercise or household strain (TENS).

Regulatory Classification

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.

Predicate Devices

• Health Expert Electronic Stimulator (K133929)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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

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# 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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# 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: [phone] Fax: [phone] Contact Person: Li Yang (General Manager) Email: [e-mail]

#### 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: [phone] Email: [e-mail]

#### 2. Subject Device Information

Trade Name: Low-frequency Multi-function physiotherapy instrument Common Name: Electronic Stimulator 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 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

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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<br>Comparison | Subject Device | Predicate Device | Verdict | |
|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|----|
| Company | Shenzhen OSTO<br>Technology Co., Ltd | Shenzhen OSTO<br>Technology Co., Ltd | -- | |
| Elements of<br>Comparison | Subject Device | Predicate Device | Verdic<br>t | |
| Trade Name | Low-frequency Multi-<br>functional physiotherapy<br>instrument | Health Expert Electronic<br>Stimulator | -- | |
| Classification Name | Stimulator, Nerve,<br>Transcutaneous, Over-<br>The-Counter | Stimulator, Nerve,<br>Transcutaneous, Over-<br>The-Counter | -- | |
| 510(k) Number | K172834 | K133929 | -- | |
| Product Code | NUH, NGX | NUH, NGX | SE | |
| Intended Use /<br>Indications for Use | PMS (Mode 1)<br>It is intended to<br>stimulate healthy<br>muscles in order to<br>improve and facilitate<br>muscle performance.<br>TENS (Mode 2)<br>To be used for<br>temporary relief of pain<br>associated with sore<br>and aching muscles in<br>the shoulder, waist,<br>back, back of the neck,<br>arm, leg, and foot due to<br>strain from exercise or<br>normal household work<br>activities<br>by applying current to<br>stimulate nerve. | PMS (Mode 1~8)<br>It is intended to<br>stimulate healthy<br>muscles in order to<br>improve and facilitate<br>muscle performance.<br>TENS (Mode 9~25)<br>To be used for<br>temporary relief of pain<br>associated with sore<br>and aching muscles in<br>the shoulder, waist,<br>back, back of the neck,<br>arm, leg, and foot due to<br>strain from exercise or<br>normal household work<br>activities<br>by applying current to<br>stimulate nerve. | SE | |
| Power Source | Adaptor Input: 100-<br>240Vac, 50-60Hz, 0.1A<br>Output: 5Vdc, 1A<br>Unit Input: 5Vdc, 1A | Adaptor Input: 100-<br>240Vac, 50-60Hz, 0.1A<br>Output: 5Vdc, 1A<br>Unit Input: 5Vdc, 1A | SE | |
| -Method of Line<br>Current Isolation | Type BF Applied Part | Type BF Applied Part | SE | |
| Patient<br>Leakage<br>Current | NC:<br>AC: 54.5µA, DC: 0.5µA<br>SFC:<br>AC:120.0µA, DC: 0.6µA | NC:<br>AC: 54.5µA, DC: 0.5µA<br>SFC:<br>AC:120.0µA, DC: 0.6µA | SE | |
| Main Unit Weight | 115 g | 2 kg | SE<br>Note 1 | |
| Main Unit Dimension | 128.6 x 69.8 x 25 mm | 428 x 428.8x 185mm | SE<br>Note 1 | |
| Number of<br>Output Channels: | 2 | 2 | SE | |
| Number of Output<br>Modes | 2 | 25 | SE<br>Note 2 | |
| Output Intensity<br>Level | 99 | 99 | SE | |
| Elements of<br>Comparison | Subject Device | Predicate Device | Verdic<br>t | |
| Synchronous or<br>Alternating? | Synchronous | Synchronous | SE | |
| Regulated Current<br>or Regulated<br>Voltage? | Yes | Yes | SE | |
| Software/Firmwar<br>e/Microprocessor<br>Control? | Yes | Yes | SE | |
| Automatic Shut<br>Off | Yes | Yes | SE | |
| Indica<br>tor<br>Displa<br>y | On/Off<br>Status | Yes | Yes | SE |
| | Low<br>Battery | No | No | |
| | Voltage/<br>Current<br>Level | Yes | Yes | |
| Timer Range | 5-60 min | 25 min | SE<br>Note2 | |
| Waveform | Pulsed, symmetric,<br>biphasic | Pulsed, symmetric,<br>biphasic | SE | |
| Shape | Rectangular, with<br>interphase interval | Rectangular, with<br>interphase interval | SE | |
| Maximum Output<br>Voltage | 44V±10% @ 500Ω | 44V±10% @ 500Ω | SE | |
| | 80V±10% @ 2KΩ | 80V±10% @ 2KΩ | | |
| | 112V±10% @ 10KΩ | 112V±10% @ 10KΩ | | |
| Maximum Output<br>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<br>operation | Temperature: 5 ~ 45<br>Humidity: 15% - 90%<br>Atmospheric pressure | Temperature: 5 ~ 45° C<br>Humidity: 20 ~ 65% RH | SE | |
| Elements of<br>Comparison | Subject Device | Predicate Device | Verdic<br>t | |
| | range of 700 hPa to 1 060<br>hPa | | | |
| Environment for<br>storage | Temperature: -25 - +70°C<br>Humidity: up to 90%<br>Atmospheric pressure<br>range of 700 hPa to 1 060<br>hPa | Temperature: 0 ~ 45° C,<br>Humidity: 10 ~ 90% RH<br>Electrode Pad: 10~20°<br>C | SE | |
| | For pads:<br>Temperature:10~20°C<br>Humidity: up to 90%<br>Atmospheric pressure<br>range of 700 hPa to 1060<br>hPa | For pads:<br>Temperature:10~20°C<br>Humidity: up to 90%<br>Atmospheric pressure<br>range of 700 hPa to 1<br>060 hPa | SE | |

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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.

#### 8. Date of the summary prepared: July 25, 2018