Who is the manufacturer of 2-in-1 Abdominal Muscle Training & Back Pain Relief System?

Tohkai Precision Electrical Manufactory (Shenzhen) Limited filed the 510(k) submission for 2-in-1 Abdominal Muscle Training & Back Pain Relief System (K152128).

What is the FDA product code for 2-in-1 Abdominal Muscle Training & Back Pain Relief System?

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

What is the regulatory pathway for 2-in-1 Abdominal Muscle Training & Back Pain Relief System?

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

What are the predicate devices for 2-in-1 Abdominal Muscle Training & Back Pain Relief System?

X2ABS Dual Channel Fitness Belt (K102295); TI040 (K060846); Shenzhen OSTO Technology Company Limited (K133929).

Who can help prepare an FDA 510(k) submission like 2-in-1 Abdominal Muscle Training & Back Pain Relief System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

2-in-1 Abdominal Muscle Training & Back Pain Relief System

K152128 · Tohkai Precision Electrical Manufactory (Shenzhen) Limited · NUH · Dec 23, 2015 · Neurology

Device Facts

Record ID	K152128
Device Name	2-in-1 Abdominal Muscle Training & Back Pain Relief System
Applicant	Tohkai Precision Electrical Manufactory (Shenzhen) Limited
Product Code	NUH · Neurology
Decision Date	Dec 23, 2015
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.5890
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

The 2-in-1 Abdominal Muscle Training & Back Pain Relief System has two intended uses; The powered muscle stimulation (PMS) Mode (TS-212) is intended to deliver electrical stimulation to the muscles of the abdomen. The transcutaneous electrical nerve stimulation TENS Mode (BP-313) is intended to deliver electrical stimulation to the peripheral nerves of the body.

Device Story

Portable multifunctional device providing TENS and PMS stimulation. Inputs: user-selected operation mode (12 total) and intensity levels. Device transforms electrical energy from a 9V battery into pulses delivered via 4 electrode pads attached to a support belt. Operates by sending electrical impulses to peripheral nerves (TENS) to block pain signals or stimulate endorphin release, or to abdominal muscles (PMS) to induce contraction. Used by patients for home-based muscle conditioning and pain relief. Healthcare providers or patients adjust settings via control unit (ON/OFF, mode selection, intensity keys). Output: mild pulsing sensation and muscle contraction. Benefits: non-invasive pain relief and improved muscle performance.

Clinical Evidence

Bench testing only. Evaluated for electrical safety (IEC 60601-1, IEC 60601-2-10), electromagnetic compatibility (IEC 60601-1-2), and biocompatibility (ISO 10993-5, ISO 10993-10). Waveform testing verified output specifications against FDA guidance for TENS and PMS devices.

Technological Characteristics

Portable device with 2 channels, 12 modes (8 TENS, 4 PMS). Power: 9V battery. Output: 2Hz-120Hz, 16-260μs pulse duration. Materials: ABS plastic housing, conductive fabric belt, gel electrode pads. Connectivity: None. Software: Microprocessor-controlled. Sterilization: Not applicable (non-sterile).

Indications for Use

Indicated for temporary relief of pain associated with sore and aching muscles in the waist, back, arm, or leg due to strain from exercise or normal activities (TENS BP-313 mode). Indicated for improvement of abdominal muscle tone, strengthening of abdominal muscles, and development of a firmer abdomen (PMS TS-212 mode).

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

X2ABS Dual Channel Fitness Belt (K102295)
TI040 (K060846)
Shenzhen OSTO Technology Company Limited (K133929)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows a logo with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around a circular seal. Inside the seal is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, creating a sense of depth and unity. The logo is simple and professional, conveying a sense of authority and trustworthiness. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 23, 2015 Tohkai Precision Electrical Manufactory (Shenzhen) Limited c/o Ms. Cecilia Ceng Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306. Kecheng Mansion No. 121 Science Road Guangzhou Science Park Guangzhou, Guangdong, 510663 China Re: K152128 Trade Name: 2-in-1 Abdominal Muscle Training & Back Pain Relief System Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH, NGX Dated: November 18, 2015 Received: November 23, 2015 Dear Ms. 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. 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 27f 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 {1}------------------------------------------------ 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 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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, # William J. Heetderks -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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K152128 Device Name 2-in-1 Abdominal Muscle Training & Back Pain Relief System Indications for Use (Describe) The 2-in-1 Abdominal Muscle Training & Back Pain Relief System has two modes of stimulation; a transcutaneous electrical nerve stimulation (TENS) BP-313 mode and a powered muscle stimulation (PMS) TS-212 mode. The TENS (BP-313 Mode) is indicated for temporary relief of pain associated with sore and aching muscles in the waist. back, arm, leg due to strain from exercise or normal household and work activities. The PMS (TS-212 Mode) is indicated for the improvement of abdominal muscle tone, for strengthening of abdominal muscles and for the development of a firmer abdomen. This system is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. Type of Use (Select one or both, as applicable) | | Prescription Use (Part 21 CFR 801 Subpart D) | |--|----------------------------------------------| | | 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}------------------------------------------------ Tohkai Precision Electrical Manufactory (Shenzhen) Limited Sponsor: Subject Device: 2-in-1 Abdominal Muscle Training & Back Pain Relief System 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. 510 (k) submitter - Company Name: Tohkai Precision Electrical Manufactory (Shenzhen) Limited - Establishment Registration Number: Applying - Address: No.3 Alley 1,Second Industrial Park, Jia Zi Tang, GongMing Office. GuangMing New ● Developed Area. ShenZhen. - Postal Code: 518132 - Phone: 0755-27173101 - Fax: 0755-27173105 - Contact Person (including title): Yuk Wing Li (General Manager) - E-mail: tohkaip@globalsoures.com #### 2. Application Correspondent - Contact Person: Ms. Cecilia Ceng / Mr. Tim Wong - Guangzhou GLOMED Biological Technology Co., Ltd. ● - Tel: +86-20-61099984 - Email: regulatory@glomed-info.com #### 3. Subject Device Information: - Common Name: Electronic Stimulator - Trade Name: 2-in-1 Abdominal Muscle Training & Back Pain Relief System - . Classification Name: Stimulator, Nerve, Transcutaneous, Muscle, Powered, For Muscle Conditioning, Over-The-Counter - Review Panel: Neurology & Physical Medicine - Product Code: NUH, NGX + - . Regulation Number: 882.5890, 890.5850 - Regulation Class: II #### 4. Predicate Device Information | | LETO ENTERPRISES INCORPORATION | Endurance Therapeutics | Shenzhen OSTO Technology Company Limited | |-----------------------------|------------------------------------|------------------------|------------------------------------------------------------------| | Sponsor | | | | | Device Name and Model | X2ABS Dual Channel Fitness Belt | TI040 | Health Expert Electronic Stimulator Model: AST-300C and | {4}------------------------------------------------ | Sponsor: | Tohkai Precision Electrical Manufactory (Shenzhen) Limited | |-----------------|------------------------------------------------------------| | Subject Device: | 2-in-1 Abdominal Muscle Training & Back Pain Relief System | | | | | AST-300D | |----------------------|----------|---------------|--------------------| | 510(k) Number | K102295 | K060846 | K133929 | | Product Code | NGX | NGX, NUH, GZJ | NUH, NGX | | Regulation Number | 890.5850 | 882.5890 | 882.5890, 890.5850 | | Regulation Class | II | II | II | #### Device Description 5. 2-in-1 Abdominal Muscle Training & Back Pain Relief System is a portable multifunctional device, offering both Transcutaneous Electronic Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) qualities. 2-in-1 Abdominal Muscle Training & Back Pain Relief System has 12 operation modes, which can give certain electrical pulse through 4 of electrode pads placed on the skin to help users to enjoy body stimulation. The support belt which fastens around your waist provides appropriate stimulation position for a quick and easy exercise for users of all different waist sizes. The adhesive pads adhere to the belt to conduct the signal from the unit to your abdominal muscles. Snap cables are for connecting the stimulator and the support belt. Each unit comes with one battery (6F22/1604) so you can start exercising right away. #### TS-212: Its technology allows you to exercise ALL of the abdominal muscles using a simple belt. A signal is sent from the belt to the nerves which control the muscles. These nerves are stimulated in the area where they are most concentrated using the model of TS-212, causing a deep, comfortable contraction of the muscles of the abdomen. You will feel a mild pulsing sensation, followed by some tightening of the skin and muscle between the pads. The muscles should contract smoothly, hold themselves in a tensed position for a few seconds and then gently relax again. If you feel a sharp prickling sensation or no feeling you should refer to the trouble shooting guide it may be that the pads are positioned directly over your hip bones and need repositioning. Once the problem is solved, just continue with your exercise. #### BP-313: The main function of pain relief comes from the continuous stimulation pulse generated from the dual channel stimulator. We cannot ensure that the pain relief is 100% effective for everyone. However, when used according to our instruction, it can be a safe, non-invasive lower back pain reliever. Transcutaneous Electrical Nerve Stimulation (TENS) relieves pain by sending small electrical impulses through electrodes placed on the skin to underlying nerve fibers. TENS is believed to work by two different mechanisms. First, electrical stimulation of the nerve fibers can block a pain signal from {5}------------------------------------------------ | Sponsor: | Tohkai Precision Electrical Manufactory (Shenzhen) Limited | |-----------------|------------------------------------------------------------| | Subject Device: | 2-in-1 Abdominal Muscle Training & Back Pain Relief System | being carried to the brain. If the signal is blocked, pain is not perceived. Secondly, the body has its own mechanism for suppressing pain. It does this by releasing natural chemicals called endorphins in the brain which act as analgesics. TENS may activate this mechanism. #### Intended Use 6. The 2-in-1 Abdominal Muscle Training & Back Pain Relief System has two intended uses; The powered muscle stimulation (PMS) Mode (TS-212) is intended to deliver electrical stimulation to the muscles of the abdomen. The transcutaneous electrical nerve stimulation TENS Mode (BP-313) is intended to deliver electrical stimulation to the peripheral nerves of the body. ### 7. Indications for Use The 2-in-1 Abdominal Muscle Training & Back Pain Relief System has two modes of stimulation; a transcutaneous electrical nerve stimulation (TENS) BP-313 mode and a powered muscle stimulation (PMS) TS-212 mode. The TENS(BP-313 Mode) is indicated for temporary relief of pain associated with sore and aching muscles in the waist, back, arm, leg due to strain from exercise or normal household and work activities. THE PMS (TS-212 Mode) is indicated for the improvement of abdominal muscle tone, for strengthening of abdominal muscles and for the development of a firmer abdomen. This system is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. #### 8. Design 2-in-1 Abdominal Muscle Training & Back Pain Relief System is a portable multifunctional device, offering both Transcutaneous Electronic Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) qualities. 2-in-1 Abdominal Muscle Training & Back Pain Relief System has 12 operation modes, which can give certain electrical pulse through 4 electrode pads placed on the skin to help users to enjoy body stimulation. It is comprised of a main device for signal generation, belts for fixation, and series electrodes. The electronic stimulatory module has the operating elements of ON/OFF Switch, Model Selection knob, Display screen, Mode Selection key and Intensity Modification keys. The device is chosen function between TENS(BP-313, Mode 1-8) and PMS(TS-212, Mode 1-4) before turning on the system. The LCD display screen can show selected mode, output intensity of body, and time remaining of an application mode. The device is equipped with accessories of electrode pads, snap cable, gel sticks, support belt. The snap cable is used to connect the pads to the main unit. All the accessories, including electrode pads, snap cable, gel sticks, support belt can only be changed by special person. #### 9. Materials There are two user directly contracting components in the subject device as the following list. | Patient Contacting Components | Material | Body Contact Location | Contact Duration | |----------------------------------|--------------------------|------------------------------------|------------------| | Button | ABS PA-757 PMMA-CM211 | Surface-contacting device: skin | Less than 30 min | | Connect line | SR8000-70N | Surface-contacting device: skin | Less than 30 min | {6}------------------------------------------------ | Sponsor: | Tohkai Precision Electrical Manufactory (Shenzhen) Limited | |-----------------|------------------------------------------------------------| | Subject Device: | 2-in-1 Abdominal Muscle Training & Back Pain Relief System | | | 510(k) Summary | |--|----------------| |--|----------------| | | TPR RN- 100PVC03 | | | |----------------|---------------------|------------------------------------|----------------------------------------------| | Belt | conductive fabric | Surface-contacting device: skin | 5 – 30 min (depends on patients' setting) | | Electrode Pads | gel | Surface-contacting device: skin | 5-30 min (depends on patients' setting) | | Unit Housing | ABS plastic | Surface-contacting device: skin | Less than 30 min | ### 10. Specification | Power Source | 1 x 6F22 battery (9 Volt) | |------------------------------------|----------------------------------------------------------------------------------| | Number of channels | Two channels | | Number of programs | TENS (BP-313): 8 PMS (TS-212): 4 | | Output intensity level | Blevel | | Frequency | 2Hz-120Hz | | Pulse Duration | $16\mu s$ -260 $\mu s$ | | Contraction and relaxation time | Adjustable, due to different modes. (See below "Program Specification Table") | | Treatment time | 5-30 minutes | | Indicator display | On/Off Status, Low Battery, Channel, Mode, Time | | Electrode size | Electrode pad: 50mm(diameter) • 1.5mm(thickness). gel stick : 48.0*48.0*1.5mm | | Control unit dimension | 125 x 72 x 39.5mm | | Weight | Approx. 150g (battery included) | | Environment for operation | Temperature: +41"Fto+104"F (+5'Cto +40'C); Humidity: 15% to 93% RH | | Environment for storage | Temperature: -13"Fto+158"F (-25'Cto +70'C); Humidity: ,;93% RH | #### 11. Test Summary 2-in-1 Abdominal Muscle Training & Back Pain Relief System 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 - Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices" {7}------------------------------------------------ | Sponsor: | Tohkai Precision Electrical Manufactory (Shenzhen) Limited | |-----------------|------------------------------------------------------------| | Subject Device: | 2-in-1 Abdominal Muscle Training & Back Pain Relief System | - 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 #### 12. Comparison to predicate device and conclusion The technological characteristics, features, specifications, mode of operation, and intended use of 2-in-1 Abdominal Muscle Training & Back Pain Relief System 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 | | |--------------------------------------|---------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|--------------| | Manufacturer | Tohkai Precision Electrical Manufactory (Shenzhen) Ltd. | LETO ENTERPRISES INCORPORATION Endurance Therapeutics Shenzhen OSTO Technology Company Limited | -- | | | Device Name and Model | 2-in-1 Abdominal Muscle Training & Back Pain Relief System | X2ABS Dual Channel Fitness Belt TI 040 Shenzhen OSTO Technology Company Limited | -- | | | 510(k) Number | Applying | K102295 K060846 K133929 | -- | | | Basic Unit Characteristics | | | | | | Power Source(s) | 1 x 6F22 battery (9 Volt) | 2 x 1.5V AAA batteries 4.5 Volt battery Adaptor Input: 100- 240Vac, 50-60Hz, 0.1A Output: 5Vdc, 1A Unit Input: 5Vdc, 1A | SE Note1 | | | -Method of Line Current Isolation | Type BF Applied Part | Type BF Applied Part Type BF Applied Part | SE | | | Patient Leakage Current | NC SFC | Comply with IEC 60601-1 and IEC 60601-2-10 Comply with IEC 60601-1 and IEC 60601-2-10 | AC: 54.5µA, DC: 0.5µA AC:120.0µA, DC: 0.6µA | SE Note 1 | {8}------------------------------------------------ | Sponsor: | Tohkai Precision Electrical Manufactory (Shenzhen) Limited | |-----------------|------------------------------------------------------------| | Subject Device: | 2-in-1 Abdominal Muscle Training & Back Pain Relief System | | Average DC current through electrodes when Device is on but no pulses are being delivered. | 0A | | 0 A | < 0.01μΑ | SE Note 1 | |-----------------------------------------------------------------------------------------------------------|-------------------------------------|----------------------------------------------|------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|--------------| | Elements of Comparison | Subject Device | | Predicate Device | | Remark | | device is on but no pulses are being applied | | | | | | | Number of Output Channels: | 2 | 2 | 1 | 2 | SE Note 1 | | Number of Output Modes | TENS (BP-313): 8 PMS (TS-212): 4 | 8 | 10 | 25 | SE Note 2 | | Output Intensity Level | 8 steps | 28 steps | | 99 steps | SE Note 2 | | Synchronous or Alternating | Synchronous | Synchronous | Synchronous | Synchronous | SE Note 2 | | Method of Channel Isolation | Voltage Transform Isolation | Up / down button of left or right channel | On/Off Switch | 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 | Regulated Voltage | Voltage Control | Voltage Control | SE | | Software/Firmwar e/Microprocessor Control? | Yes | | Yes | Yes | SE | | Automatic Overload Trip | No | No | No | No | SE | {9}------------------------------------------------ | Sponsor: | Tohkai Precision Electrical Manufactory (Shenzhen) Limited | |-----------------|------------------------------------------------------------| | Subject Device: | 2-in-1 Abdominal Muscle Training & Back Pain Relief System | | | 510(k) Summary | | | | | |------------------------|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|----|----|-----------| | Automatic No-Load Trip | Yes. The unit will not work and the icon of the corresponding unit will twinkle if no load is connected. | Yes. The unit will not work and the unit will sound a beeping alarm if no load is connected. | No | No | SE Note 2 | | Elements of Comparison | Subject Device | Predicate Device | Remark | | | | |---------------------------------------|------------------------------|----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|------------------------------|--------------------------------|--------------| | Automatic Shut Off | Yes | After approximately 10 minutes, the AUTO OFF function will turn off the unit, if it is not in use. | No | Yes | SE | | | User Override Control | Yes | Yes | Yes | Yes | SE | | | Indicator On/Off Display | Status | Yes | Yes | Yes | Yes | SE | | | Low Battery | Yes | Yes | Yes | No | SE Note 2 | | | Voltage/ Current Level | Yes | Yes | No | Yes | SE Note 2 | | Timer Range | | adjustable from 5 - 30 minutes | Default time is 10 minutes, minimum time is 5 | -- | Yes | SE Note 2 | | Weight | | Approx. 150g (battery included) | 81.2g (with battery) | 14.4 oz | 2Kg (Without accessories) | SE Note 2 | | Dimensions | | 125 x 72 x 39.5mm | 82 mm (L) X 62 mm (W) X 23 mm (H) | 6 in(W)*1 in(H)*2.8 in(D) | 428mm x 428.8mm x 185mm | SE Note 2 | | Housing Materials and Construction | | Main unit: ABS plastic | -- | ABS | Main unit: ABS plastic | SE | | Output Specifications | | | | | | | | Waveform | | TENS (BP-313): Monophasic PMS (TS-212): Biphasic | Biphasic | Biphasic | Pulsed, symmetric, biphasic | SE | {10}------------------------------------------------ | Sponsor: | Tohkai Precision Electrical Manufactory (Shenzhen) Limited | |-----------------|------------------------------------------------------------| | Subject Device: | 2-in-1 Abdominal Muscle Training & Back Pain Relief System | | Shape | Rectangular | Rectangular | Rectangular | Rectangular, with interphase interva | SE | |----------------------------------------|---------------------------------------------------------------------------------|--------------------------------------------------------|--------------------|------------------------------------------------|--------------| | Maximum Output Voltage | 42V±10% @ 500Ω | From 0 to 60 mA (From 0 to 1000 Ω) | 40.7V±20% @ 500 Ω | 44V±10% @ 500Ω | SE Note 3 | | | 78V±10% @ 2ΚΩ | | 105.1V±20% @ 2 kΩ | 80V±10% @ 2ΚΩ | | | | 94V±10% @ 10ΚΩ | | 154.1V±20% @10 kΩ | 112V±10% @10ΚΩ | | | Maximum Output Current | 84mA±10% @ 500Ω | -- | 81.4mA±20% @ 500 Ω | 88mA±10% @ 500Ω | SE Note 3 | | | 39mA±10% @ 2ΚΩ | | 47.8mA±20% @ 2 kΩ | 40mA±10% @ 2ΚΩ | | | | 9.4mA±10% @ 10ΚΩ | | 15.4mA±10% @10 kΩ | 11.2mA±10% @ 10ΚΩ | | | Pulse Duration | 16μs ~260μs | 200μs | 4.1–500ms | 120μs | SE Note 3 | | Pulse frequency | 2Hz-120Hz | 8.5~64Hz | 245Hz | 77.3Hz | SE Note 3 | | Net charge | 21.84μC @ 500Ω | -- | 4.07μC @ 500Ω | 0μC @ 500Ω Method: Balanced waveform | SE Note 3 | | Maximum Phase Charge | 21.84µC @ 500Ω | -- | 16.90μC @ 500Ω | 12.78μC @ 500Ω | SE Note 3 | | Maximum Average Current | 2.25mA @ 500Ω | -- | 4.25 mA | 0.968mA @ 500Ω | SE Note 3 | | Maximum Current Density (r.m.s ) | 0.153mA/ cm2 (without DC current ) | 0.032 (for the smallest size electrode 32.0 cm²) | 2.71mA/cm² @500Ω | 0.235mA/cm² @ 500Ω | SE Note 3 | | Maximum Average Power Density | 0.232mW/cm² 500Ω | @ 0.23W/cm² @ 500Ω | 5.35mW/cm² | 1.38mW/cm² @ 500Ω | SE Note 3 | | ON Time | 1s | 1s | -- | 0.6s | SE Note 3 | | OFF Time | 10ms | 2s | -- | 0.6s | SE Note 3 | | Additional Features | | | | | | | Environment for operating | Temperature: +41°F to+104°F (+5°C to +40℃); Humidity: 15% to 93% RH | Temperature: 5 ~ 40° C Humidity: 20 ~ 65% RH | | Temperature: 5 ~ 45°C Humidity: 20 ~ 65% RH | SE Note 1 | {11}------------------------------------------------ | Sponsor: | Tohkai Precision Electrical Manufactory (Shenzhen) Limited | |-----------------|------------------------------------------------------------| | Subject Device: | 2-in-1 Abdominal Muscle Training & Back Pain Relief System | | 510(k) Summary | | | | | | |----------------------------|--------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|------------------|--------------------------------------------------------------------------------------------------------------------|--------------| | Environment for storage | Temperature: -13°F to+158°F (-25°C to +70°C); | Temperature: 0 ~ 40° C Humidity: 10 ~ 90% | | Temperature: 0 ~ 45°C, Humidity: 10 ~ 90% | SE Note 1 | | Elements of Comparison | Subject Device | | Predicate Device | | Remark | | | Humidity: ≤93% RH | RH | | RH Electrode Pad: 10~20°C | | | Standards | | | | | | | 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. | -- | 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 | -- | Comply with IEC 60601-1 and IEC 60601-2-10 | SE | | EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | -- | Comply with IEC 60601-1-2 | SE | # Programs | | Program | Maximum | Phase Duration | Rate | |--------------|---------|---------|--------------------|------------| | BP-313(TENS) | 1 | 84mA | 260 μs | 16Hz | | | 2 | 84mA | 260 μs | 100Hz | | | 3 | 50mA | 260 μs | 120Hz | | | 4 | 80mA | 260~160 μs | 2Hz~100Hz | | | 5 | 54mA | 260~160 μs | 100Hz | | | 6 | 80mA | 260 μs | 80<->10 Hz | | | 7 | 52mA | 260~160 μs | 120Hz | | | 8 | 84mA | P1~P7 | Cycle | | TS-212(PMS) | 1 | 52mA | 200 μs | 70Hz | | | 2 | 52mA | 200 μs | 60Hz | | | 3 | 52mA | 200 μs | 50Hz | | | 4 | 52mA | 200 μs | 50Hz | {12}------------------------------------------------ | Sponsor: | Tohkai Precision Electrical Manufactory (Shenzhen) Limited | |-----------------|------------------------------------------------------------| | Subject Device: | 2-in-1 Abdominal Muscle Training & Back Pain Relief System | ### Comparison in Detail(s): #### Note 1: Although the " Power Source(s)", " Patient Leakage 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 Intensity Level", " Method of Channel Isolation", " Timer Range", "Vleight" 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" are a little different from the predicate devices, they all comply with IEC 60601-1, IEC 60601-2-10 requirement for Transcutaneous Electical 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 2-in-1 Abdominal Muscle Training & Back Pain Relief System has all features of the predicate devices. The differences between them do not affectiveness. Thus, the subject device is substantially equivalent to the predicate devices. ### 13. Date of the summary prepared: December 16, 2015

2-in-1 Abdominal Muscle Training & Back Pain Relief System

Device Facts

Indications for Use

Device Story

Clinical Evidence

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2-in-1 Abdominal Muscle Training & Back Pain Relief System

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Device Story

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