Low-frequency Stimulator (Model: AST-645, AST-646)

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November 22, 2021 Shenzhen OSTO Technology Co., Ltd. % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou, Guangdong 510700 China Re: K212989 Trade/Device Name: Low-frequency Stimulator (Model: AST-645, AST-646) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH, NGX, NYN, GZJ, IPF, IRT Dated: September 15, 2021 Received: September 20, 2021 Dear Cassie Lee: We have reviewed vour 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health {2}------------------------------------------------ # Indications for Use ### 510(k) Number (if known) K212989 Device Name Low-frequency Stimulator (Model: AST-645, AST-646) Indications for Use (Describe) TENS: 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. It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. ### PMS: It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. Heating: It is intended for temporary relief of minor aches and pains. | 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) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary for K212989 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: 3011564440 - � 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 � ### 2. Application Correspondent: - � Contact Person: Ms. Cassie Lee - Guangzhou GLOMED Biological Technology Co., Ltd. � - Address: 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, � Guangdong, China - � Tel: +86 20 8266 2446 - Email: regulatory@glomed-info.com � ### 3. Subject Device Information - � Trade Name: Low-frequency stimulator (Model AST-645, AST-646) - � Common Name: Over-the-counter Transcutaneous Electrical Nerve Stimulator - � Classification name: Transcutaneous Electrical Nerve Stimulator For Pain Relief - � Review Panel: Physical Medicine - NUH, NGX, NYN, GZJ, IPF, IRT Product Code: � - ll � Requlation Class: - 882.5890 Regulation Number: � - 4. Predicate Device Information ### Primary Predicate Devic Information - Jkh Usa, LLC � Sponsor - JKH Stimulator Plus � Device Name and Model - � 510(k) Number K191151 {4}------------------------------------------------ - NUH, NGX, NYN, GZJ, IPF, IRT � Product Code - � Regulation Number 882.5890 - Requlation Class � 11 # Secondary Predicate Device Information - Shenzhen OSTO Technology Company Limited Sponsor - Health Expert Electronic Stimulator (Model: AST-300L) � Device Name and Model - K190783 � 510(k) Number - NUH, NGX � Product Code - 882.5890, 890.5850 � Regulation Number - � Requlation Class ll ### 2. Device Description � The Low-frequency stimulator is a portable device. It has 10 modes: 9 stimulation modes each has 99 levels of intensity and 1 heating mode has 3 levels of heating intensity, which can give certain stimulation to help the users relax their muscle and relief their pain. The Low-frequency stimulator has 7 buttons on the main unit: Press Power button to turn on/off the device. Press "Mode+" and "Mode-" buttons to select 9 stimulation modes; Press "Intensity+" and "Intensity-" to increase or decrease the stimulus intensity, there are a total of 99 intensities to choose from; Press "Heat" to adjust the heating temperature, there are three temperatures(38℃, 40℃ and 43℃) that can be adjusted. Press "Time" to adjust the treatment time, increasing by five minutes each time, up to 60 minutes. It will automatically shut down in 30 minutes by default when it is turned on. The LCD screen can show stimulation intensity, heating intensity, heating intensity and time remaining of an application mode. All the functions of the device can only be controlled by the button on the main unit. The device is equipped with an adapter, bandage, a pair of electrode wire. The electrode wire is used to connect the electrode pads to the main unit. There are four conductive heads on the main unit, which are mainly composed of stainless steel sheets and giving users stimulation and heating functions, and help users relieve knee pain. The stimulation and heating functions can happen simultaneously or independently by control the button on the main unit. When in use, the main unit is fixed with a bandage, and the electrode sheet is placed at the relevant treatment site according to the instructions. The electrode pads can be used on the guidance site for stimulation only when connected to the host. There are two models of the device, which differ only in appearance. The electrode pads are complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are interchangeable. # 5. Intended Use / Indications for Use TENS: {5}------------------------------------------------ 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. It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. # PMS: It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. ### Heating: lt is intended for temporary relief of minor aches and pains. # 6. Test Summary ## 6.1 Non-clinical testing was conducted to verify that the subject device met all design specifications, demonstrated safety based on current industry standards, and to demonstrate substantial equivalence to the predicate. The following tests were performed: Low-frequency stimulator 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 62366-1 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 # 6.2 Summary of Clinical Performance Test No clinical study is included in this submission. ### 7. Comparison to predicate device and conclusion The technological characteristics, features, specifications, materials, Mode of operation, and intended use of Low-frequency 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 of<br>Comparison | Subject Device | Primary Predicate Device | Secondary Predicate<br>Device | Remark | | |--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|--------------| | Device Name | Low-frequency stimulator<br>(Model: AST-645, AST-646) | JKH Stimulator Plus | Health Expert Electronic<br>Stimulator<br>Model: AST-300L | -- | | | 510(k) Number | K212989 | K191151 | K190783 | -- | | | Elements of<br>Comparison | Subject Device | Primary Predicate Device | Secondary Predicate<br>Device | Remark | | | Intended Use | TENS:<br>To be used for temporary<br>relief of pain associated<br>with sore and aching<br>muscles in the shoulder,<br>waist, back, back of the<br>neck, arm, leg, and foot<br>due to strain from<br>exercise or normal<br>household work activities<br>by applying current to<br>stimulate nerve.<br>It is also intended for<br>symptomatic relief and<br>management of chronic,<br>intractable pain and relief<br>of pain associated with<br>arthritis.<br>PMS:<br>It is intended to stimulate<br>healthy muscles in order<br>to improve and facilitate<br>muscle performance.<br>Heating:<br>It is intended for<br>temporary relief of minor<br>aches and pains. | TENS:<br>PL-029K5BL, PL-029K15,<br>and PL-029T are used for<br>temporary relief of pain<br>associated with sore and<br>aching muscles in the<br>shoulder, waist, back, arm,<br>and leg, due to strain from<br>exercise or normal<br>household and work<br>activities.<br>PL-029K5BL, PL-029K15,<br>and PL-029T are also<br>intended for symptomatic<br>relief and management of<br>chronic, intractable pain<br>and relief of pain<br>associated with arthritis.<br>The device of PL-029K5BL<br>and PL-029K15 may be<br>used during sleep. The<br>device of PL- 029K5BL and<br>PL-029K15 is labeled for<br>use only with its own<br>compatible electrodes.<br>PMS:<br>PL-029K5BL, PL-029K15,<br>and PL-029T are used to<br>stimulate healthy muscles<br>in order to improve and<br>facilitate muscle<br>performance. To be used<br>for the improvement of<br>muscle tone and firmness,<br>and for strengthening<br>muscles in the arms,<br>abdomen, legs, and<br>buttocks. Not intended for<br>use in any therapy or for<br>the treatment of any<br>medical conditions or<br>diseases.<br>PL-029K5BL, PL-029K15,<br>and PL-029T are also<br>intended to temporarily<br>increase local blood<br>circulation in the healthy<br>muscles of lower<br>extremities.<br>Heating: | PMS (Mode 1~8)<br>It is intended to stimulate<br>healthy muscles in order<br>to 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 and<br>aching muscles in the<br>shoulder, waist, back,<br>back of the neck, arm,<br>leg, and foot due to<br>strain from exercise or<br>normal household work<br>activities by applying<br>current to stimulate<br>nerve. | SE | | | Elements of<br>Comparison | Subject Device | Primary Predicate Device | Secondary Predicate<br>Device | Remark | | | | | | The device of PL-029T is<br>intended for temporary<br>relief of minor aches and<br>pains. | | | | Power Source(s) | | Powered by adapter,<br>100-240VAC, 50-60Hz<br>Output: 9Vdc, 2A<br>Unit Input: 9Vdc, 2A | Rechargeable or non-<br>rechargeable battery | Adaptor Input:<br>100-240Vac, 50-60Hz,<br>0.1A<br>Output: 5Vdc, 2A<br>Unit Input: 5Vdc, 2A | SE<br>Note 1 | | -Method of Line<br>Current Isolation | | Type BF Applied Part | Battery Supply | Type BF Applied Part | SE | | -Patient<br>Leakage<br>Current | NC | DC: <1μA | N/A | AC: 54.5, DC: 0.5μA | SE<br>Note 1 | | | SFC | DC: <1μA | N/A | AC: 54.5, DC: 0.5μA | | | Number of Output<br>Channels: | | 2 | 1-2 | 2 | SE | | Number of Output<br>Modes | | For stimulation: 9 modes<br>For heating: 1 mode | PL-029K5BL: 6-8 PL-<br>029K15: 1-4 PL-029T: 8 | 25 | SE<br>Note 2 | | Output<br>Intensity<br>Level | | For stimulation: 99 levels<br>For heating: 3 levels<br>(38°C, 40°C and 43°C) | N/A | 99 steps | SE<br>Note 2 | | Synchronous or<br>Alternating | | Synchronous | N/A | Synchronous | SE | | Method of Channel<br>Isolation | | 2 | N/A | 2 | SE | | Regulated Current<br>or Regulated<br>Voltage? | | Voltage | Voltage | Voltage Control | SE | | Software/Firmware/<br>Microprocessor<br>Control? | | Yes | Yes | Yes | SE | | Automatic<br>Overload Trip | | No | No | No | SE | | Automatic No-Load<br>Trip | | No | Yes | No | SE | | Automatic Shut Off | | Yes | Yes | Yes | SE | | Elements of<br>Comparison | | Subject Device | Primary Predicate Device | Secondary Predicate<br>Device | Remark | | Indicator<br>Display | Override | Yes | Yes | Yes | SE | | | On/Off<br>Status | Yes | Yes | Yes | SE | | | Low<br>battery | No | Yes | No | SE | | Voltage /<br>current<br>level | | Yes | Yes | Yes…