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Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W)

Q: Who is the manufacturer of Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W)?

Shenzhen Osto Technology Company Limited filed the 510(k) submission for Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W) (K211736).

Q: What is the FDA product code for Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W)?

NUH. It is classified under 21 CFR 882.5890 as a Class 2 device in the Neurology panel.

Q: What is the regulatory pathway for Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W)?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W)?

Health Expert Electronic Stimulator (K190673).

K211736 · Shenzhen Osto Technology Company Limited · NUH · Sep 5, 2021 · Neurology

Device Facts

Record ID	K211736
Device Name	Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W)
Applicant	Shenzhen Osto Technology Company Limited
Product Code	NUH · Neurology
Decision Date	Sep 5, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.5890
Device Class	Class 2
Attributes	Therapeutic

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.

Device Story

Portable, adapter-powered electronic muscle stimulator; provides TENS and PMS therapy. Inputs: user-selected operation mode (25 modes), intensity levels (99 steps), and treatment time. Device transforms inputs into pulsed, symmetric, biphasic electrical currents delivered via 4 skin-contact electrode pads or 2 integrated foot-sole electrodes. Operated by the user in a home/non-clinical setting. Device features LCD screen for mode, intensity, and timer display. Output provides muscle stimulation or nerve stimulation for pain relief. Healthcare provider role is minimal; device is for OTC use. Benefits include improved muscle performance and temporary pain relief.

Clinical Evidence

No clinical data. Safety and performance verified via bench testing, including electrical safety (IEC 60601-1, IEC 60601-1-11, IEC 60601-2-10), electromagnetic compatibility (IEC 60601-1-2), biocompatibility (ISO 10993-5, ISO 10993-10), and usability (IEC 62366-1).

Technological Characteristics

ABS plastic housing; Type BF applied part; 2 output channels; 25 operation modes; 99 intensity steps; pulsed, symmetric, biphasic waveform; 120µs pulse width; 77.3Hz frequency. Powered by 100-240Vac adapter (5Vdc output). Microprocessor-controlled. Biocompatible electrode pads (ISO 10993-5/10).

Indications for Use

Indicated for healthy individuals requiring muscle performance improvement (PMS) or 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 (K190673)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. September 5, 2021 Shenzhen OSTO Technology Company Limited % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. Room 2231, Building 1, Ruifeng Center, Kaichuang Road Huangpu District Guangzhou City Guangdong, China Re: K211736 Trade/Device Name: Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: May 31, 2021 Received: June 7, 2021 Dear Cassie Lee: 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/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. Pamela Scott Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K211736 Device Name Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300T, AST-300T, AST-300V, AST-300W) 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. | 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 K211736 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 ### Application Correspondent: 2. - � 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 - Electronic Muscle Stimulator � Trade Name: - Electronic Stimulator Common Name: � - Stimulator, Nerve, Transcutaneous, Muscle, Powered, For � - Classification name: Muscle Conditioning, Over-The-Counter - Neurology, Physical Medicine Review Panel: � ll - NUH, NGX Product Code: � - � Regulation Class: - 882.5890, 890.5850 Regulation Number: � ### 4. Predicate Device Information - Sponsor Shenzhen OSTO Technology Company Limited � Health Expert Electronic Stimulator � Device Name and Model Model: AST-300F, AST-300H, AST-300J {4}------------------------------------------------ - 510(k) Number K190673 � - NUH, NGX Product Code � - � Regulation Number 882.5890, 890.5850 - � Requlation Class II #### 2. Device Description Electronic Muscle Stimulator is a portable and adapter powered multifunctional device, offering both Transcutaneous Electronic Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) qualities. Electronic Muscle 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. The electronic stimulatory module has the operating elements of ON/OFF Switch, Display screen, Mode Selection key and Intensity Modification keys. The models AST-300A and AST-300W have 9 buttons which is more than other models. Compared with other models, the "Time+" and "Time-" buttons are used to adjust the treatment time. The LCD display screen can show selected mode, output intensity of body and/or sole, and time remaining of an application model. The device is equipped with accessories of electrode pads, 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 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 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 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 {5}------------------------------------------------ # demonstrate substantial equivalence to the predicate. The following tests were performed: Electronic Muscle 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" # 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 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 of Comparison | Subject Device | Predicate Device | Remark | | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|---------| | Device Name and Model | Electronic Muscle Stimulator Model: AST-300A, AST-300N, AST-300S, AST-300T , AST-300V, AST-300W | Health Expert Electronic Stimulator Model: AST-300F, AST-300H, AST-300J | -- | | | 510(k) Number | Applying | K190673 | -- | | | Intended Use | PMS (Mode 1~8) It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. TENS (Mode 9~25) | PMS (Mode 1~8) It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. TENS (Mode 9~25) | SE | | | Elements of Comparison | Subject Device | Predicate Device | Remark | | | 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. | 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. | | | | | Power Source(s) | 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 | NC | AC: 54.5 $\mu$ A, DC: 0 $\mu$ A | AC: 54.5 $\mu$ A, DC: 0.5 $\mu$ A | SE | | | SFC | AC:120.0 $\mu$ A, DC: 0 $\mu$ A | AC:120.0 $\mu$ A, DC: 0.6 $\mu$ A | | | Average DC current through electrodes when device is on but no pulses are being applied | < 0.01 $\mu$ A | < 0.01 $\mu$ A | SE | | | Number of Output Channels: | 2 | 2 | SE | | | Number of Output Modes | 25 | 25 | SE | | | Output Intensity Level | 99 steps | 99 steps | SE | | | Synchronous or Alternating? | Synchronous | Synchronous | SE | | | Elements of Comparison | | Subject Device | Predicate Device | Remark | | Method of Channel Isolation | | Voltage Transform Isolation "Body+" and "Body-" buttons for body channel, "Sole+" and "Sole-" buttons for feet channel | Voltage Transform Isolation "Body+" and "Body-" buttons for body channel, "Sole+" and "Sole-" buttons for feet channel | SE | | Regulated Current or Regulated Voltage? | | Voltage Control | Voltage Control | SE | | Software/Firmware/Microprocessor Control? | | Yes | Yes | SE | | Automatic Overload Trip | | No | No | SE | | Automatic No-Load Trip | | No | No | SE | | Automatic Shut Off | | Yes | Yes | SE | | User Override Control | | Yes | Yes | SE | | Indicator Display | On/Off Status | Yes | Yes | SE | | | Low Battery | No | No | SE | | | Voltage/ Current Level | Yes | Yes | SE | | Timer Range | | AST-300N, AST-300S, AST-300T and AST-300V: 25 min (default); AST-300A and AST-300W: can adjust the time (5-25min) | 25min | SE | | Weight | | AST-300A: 1.62kg AST-300N: 1.5kg AST-300S: 1.23kg AST-300T: 1.92kg AST-300V: 1.93kg AST-300W: 1.99kg | 1.9Kg (Without accessories) | SE Note | | Dimensions | | AST-300A: | 429.1mm x 426.6mm x 153.8mm | SE Note | | Elements of Comparison | Subject Device | Predicate Device | Remark | | | | 209.7*215.3*52.3mm AST-300N: 403.7*402.6*47.3mm AST-300S: 345.5*316.1*74.2mm AST-300T: 401.9*401.3*158.9mm AST-300V: 464.6*419.6*181.0mm | | | | | | AST-300W: 464.7*419.6*181mm | | | | | Housing Materials and Construction | Main unit: ABS plastic | Main unit: ABS plastic | SE | | | Waveform | Pulsed, symmetric, biphasic | Pulsed, symmetric, biphasic | SE | | | Shape | Rectangular, with interphase interval | Rectangular, with interphase interval | SE | | | Maximum Output Voltage | 44V±10% @ 500Ω | 44V±10% @ 500Ω | SE | | | | 80V±10% @ 2KΩ | 80V±10% @ 2KΩ | SE | | | | 112V±10% @ 10KΩ | 112V±20% @ 10KΩ | SE | | | Maximum Output Current | 88mA±10% @ 500Ω | 88mA±10% @ 500Ω | SE | | | | 40mA±10% @ 2KΩ | 40mA±10% @ 2KΩ | SE | | | | 11.2mA±10% @ 10KΩ | 11.2mA±10% @ 10KΩ | SE | | | Pulse width | 120µs | 120µs | SE | | | Pulse frequency | 77.3Hz | 77.3Hz | SE | | | Net Charge (per pulse) | 0µC @ 500Ω Method: Balanced waveform | 0µC @ 500Ω Method: Balanced waveform | SE | | | Maximum Phase Charge | 10.56μC @ 500Ω | 10.56μC @ 500Ω | SE | | | Maximum Average Current | 1.63mA @ 500Ω | 1.63mA @ 500Ω | SE | | | Elements of Comparison | Subject Device | Predicate Device | Remark | | | Maximum Current Density (r.m.s ) | 0.0326mA/cm² @ 500Ω | 0.0326mA/cm2 @500Ω | SE | | | Maximum Average Power Density | 0.0000266mW/cm² @ 500Ω | 0.0000266mW/cm² @ 500Ω | SE | | | ON Time | 0.6s | 0.6s | SE | | | OFF Time | 0.6s | 0.6s | SE | | | Environment for operating | Temperature: 5 ~ 45° C Humidity: 20 ~ 65% RH | Temperature: 5 ~ 45°C Humidity: 20 ~ 65% RH | SE | | | Environment for storage | Temperature: 0 ~ 45°C, Humidity: 10 ~ 90% RH Electrode Pad: 10~20°C | Temperature: 0 ~ 45°C, Humidity: 10 ~ 90% RH Electrode Pad: 10~20°C | SE | | | Biocompatibility | All user directly contacting materials are compliance with ISO10993-5 and ISO10993-10 requirements. | All user directly contacting materials are compliance with ISO10993-5 and ISO10993-10 requirements. | SE | | | Electrical Safety | Comply with IEC 60601-1 and IEC 60601-2-10 | Comply with IEC 60601-1 and IEC 60601-2-10 | SE | | | EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SE | | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ # Comparison in Detail(s): # Note: Although the "Weight" and "Dimensions" are a little different from the predicate device, but the differences will not raise any safety or effectiveness issue. # Final Conclusion: {10}------------------------------------------------ The subject devices "Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W) are Substantial Equivalent to the predicate device K190673. # 8. Date of the summary prepared: September 2, 2021

Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W)

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Device Story

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Technological Characteristics

Indications for Use

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Submission Summary (Full Text)

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Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W)

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

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Special Control Matches

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