Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212)

K191982 · Shenzhen Kentro Medical Electronics Co., Ltd. · NUH · Sep 25, 2020 · Neurology

Device Facts

• Record ID: K191982
• Device Name: Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212)
• Applicant: Shenzhen Kentro Medical Electronics Co., Ltd.
• Product Code: NUH · Neurology
• Decision Date: Sep 25, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

KTR-2210, KTR-2220, KTR-2230: (TENS, EMS, FITNESS) TENS (Mode 1~20): 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. EMS (Mode 21~40): It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. FITNESS (Mode 41~50): Improvement of abdominal tone, strengthening of the abdominal muscles development of firmer abdomen. KTR-2211, KTR-2221, KTR-2231, KTR-2212, KTR-2222, KTR-2232: (TENS) 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, battery-powered physiotherapy instrument; provides TENS, EMS, and FITNESS modes. Device delivers electrical pulses via 4 electrode pads placed on skin. User interface includes ON/OFF key, LCD screen, mode selection, and intensity modification keys. LCD displays mode, program, output intensity, frequency, and remaining time. Used in home/clinic settings by patients or operators. Device transforms electrical energy into pulsed, symmetric, biphasic waveforms to stimulate nerves or muscles. Output affects muscle performance or provides pain relief through nerve stimulation. Benefits include temporary pain relief, muscle conditioning, and abdominal toning.

Clinical Evidence

Bench testing only. Evaluated per IEC 60601-1 (electrical safety), IEC 60601-1-11, IEC 60601-2-10 (stimulator safety), IEC 60601-1-2 (EMC), ISO 10993-1/5/10 (biocompatibility), and IEC 62366-1 (usability). Waveform output verified against FDA guidance for TENS and powered muscle stimulators.

Technological Characteristics

Portable, battery-powered (3xAAA). ABS plastic housing. Pulsed, symmetric, biphasic waveform. Type BF applied part. 4 electrode channels. Biocompatible pads (ISO 10993-5/10). Microprocessor-controlled. Output: 55V-85V (depending on load), 8.5mA-110mA. Frequency: 1-100Hz. Pulse duration: 120-200µs.

Indications for Use

Indicated for temporary relief of pain in shoulder, waist, back, neck, arm, leg, and foot due to strain; stimulation of healthy muscles to improve performance; and improvement of abdominal tone/strengthening. For use by adults.

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, Model: AST-300C and AST-300D (K133929)

Reference Devices

• Pain Therapy Device, Models: P.T.S-11, P.T.S-IIA, P.T.S-11B, CP-I (K163611)
• Intelligent Wireless Fitness Apparatus, Models: AST-301, AST-302, AST-303 (K182136)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

September 25, 2020

Shenzhen Kentro Medical Electronics Co., Ltd Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. Room 2231, Building 1, Ruifeng Center, Kaichuang Road Huangpu District Guangzhou, Guangdong 51006 China

Re: K191982

Trade/Device Name: Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-222, KTR-2212) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: March 20, 2020 Received: June 29, 2020

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

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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Heather Dean, PhD Assistant Director, Acute Injury Devices Team 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

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# Indications for Use

510(k) Number (if known) K191982

#### Device Name

Low-frequency Multi-function physiotherapy instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2211, KTR-2211, KTR-2232, KTR-2212)

#### Indications for Use (Describe)

KTR-2210, KTR-2220, KTR-2230: (TENS, EMS, FITNESS)

TENS (Model~20): 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.

EMS (Mode 21~40): It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. FITNESS (Mode 41-50): Improvement of abdominal tone, strengthening of the abdominal muscles development of firmer abdomen.

KTR-2211, KTR-2221, KTR-2231, KTR-2212, KTR-2222, KTR-2232: (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.

Type of Use (Select one or both, as applicable)

| <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input checked="" type="checkbox"/> 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.

#### Submitter's Information 1.

- � 510(k) Owner's Name: Shenzhen Kentro Medical Electronics Co., Ltd
- � Establishment Registration Number: 3013671142
- Address: No.3, Xihu industry zone, Xikeng Village, Henggang Town, Longgang District, Shenzhen, � Guangdong, China
- � Tel: [phone]
- � Fax: [phone]
- Contact Person: Zewu Zhang (General Manger) �
- Email: [e-mail] �

#### 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: [phone] �

Email: regulatory@glomed-in fo.com

#### Subject Device Information 3.

- � Trade Name: Low-frequency Multi-function physiotherapy instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212) Common Name: � Electronic Stimulator
- Stimulator, Nerve, Transcutaneous, Muscle, Powered, For � Classification name: Muscle Conditioning, Over-The-Counter
- � Review Panel: Neurology, Physical Medicine
- � Product Code: NUH, NGX
- � Regulation Class: ll
- Regulation Number: � 882.5890, 890.5850

#### 4. Predicate Device Information

| | Primary Predicate Device | Reference Device 1 | Reference Device 2 |
|---------|---------------------------------------------|-----------------------------------------|-------------------------------------------|
| Sponsor | Shenzhen OSTO Technology<br>Company Limited | Guangzhou Xinbo Electronic<br>Co., Ltd. | Shenzhen OSTO<br>Technology Co., Ltd. |
| Device | Health Expert Electronic | Pain Therapy Device | Intelligent Wireless Fitness<br>Apparatus |

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| Name and<br>Model | Stimulator, Model: AST-300C<br>and AST-300D | Models:P.T.S-11, P.T.S-<br>IIA, P.T.S-118 , CP-I | Models: AST-301, AST-302,<br>AST-303 |
|----------------------|---------------------------------------------|--------------------------------------------------|--------------------------------------|
| 510(k)<br>Number | K133929 | K163611 | K182136 |
| Product<br>Code | NUH, NGX | NUH, NGX | NGX |
| Regulation<br>Number | 882.5890, 890.5850 | 882.5890, 890.5850 | 890.5850 |
| Regulation<br>Class | II | II | II |

### 5. Device Description

Low-frequency Multi-function physiotherapy instrument (Models: KTR-2210) is a portable and battery powered multifunctional device, offering Transcutaneous Electronic Nerve Stimulator (TENS), Electronic Muscle Stimulator (EMS) and FITNESS qualities.

Low-frequency Multi-function physiotherapy instrument (Models: KTR-2210) has 50 operation modes, which can give certain electrical pulse through 4 pcs of electrode pads placed on the skin to help users to enjoy body massage.

The electronic stimulatory module has the operating elements of ON/OFF Key, Display screen, Mode Selection key and Intensity Modification keys.

The LCD display screen can show selected mode and program, output intensity, stimulate frequency, and time remaining of an application mode.

The device is equipped with accessories of electrode wires, and batteries. The electrode wire is used to connect the patches to the main unit. All the accessories, including electrode pads, electrode wire, and batteries can only be changed by special person.

The electrode pads are complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are interchangeable.

#### 6. Intended Use / Indications for Use

KTR-2210, KTR-2220, KTR-2230: CTENS, EMS, FITNESS)

TENS (Mode1~20:) 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.

EMS (Mode 21~40): It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.

FITNESS (Mode 41~50): Improvement of abdominal tone, strengthening of the abdominal muscles development of firmer abdomen.

#### KTR-2211, KTR-2221, KTR-2231, KTR-2212, KTR-2222, KTR-2232: (TENS)

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.

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### 7. Test Summary

Low-frequency Multi-function physiotherapy instrument 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 10993-1, 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

### 8. Comparison to predicate device and conclusion

The technological characteristics, features, specifications, materials, mode of operation, and intended use of Low-frequency Multi-function physiotherapy instrument 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<br>Device | Reference Device<br>1 | Reference<br>Device 2 | Remark | |
|--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|--------------|
| Device Name and<br>Model | Low-frequency Multi-<br>function physiotherapy<br>instrument<br>Model: KTR-2230, KTR-<br>2220, KTR-2210, KTR-<br>2231, KTR-2221, KTR-<br>2211, KTR-2232, KTR-<br>2222, KTR-2212 | Low-frequency Multi-<br>function physiotherapy<br>instrument<br>Model: AST-300C and<br>AST-300D | Pain Therapy<br>Device, Models:<br>P.T.S-11, P.T.S-IIA,<br>P.T.S-11B, CP-I | Intelligent<br>Wireless<br>Fitness<br>Apparatus<br>Models: AST-<br>301, AST-302,<br>AST-303 | | |
| 510(k) Number | Applying | K133929 | K163611 | K182136 | | |
| Intended Use | KTR-2210 , KTR-2220 ,<br>KTR-2230 : (TENS , EMS, FITNESS)<br>TENS (Mode1~20): To<br>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 | 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, | To be used for<br>temporary relief of<br>pain associated with<br>sore and aching<br>muscles in the<br>upper and lower<br>back, back of the<br>neck, upper<br>extremities<br>(shoulder and arm),<br>lower extremities<br>(leg and feet) due to | Intelligent<br>Wireless<br>Fitness<br>Apparatus is<br>indicated to be<br>used for:<br>Improvement<br>of abdominal<br>tone,<br>strengthening<br>of the | SE<br>Note 1 | |
| Elements of<br>Comparison | Subject Device | Primary Predicate<br>Device | Reference Device<br>1 | Reference<br>Device 2 | Remark | |
| | household work activities<br>by applying current to<br>stimulate nerve.<br>EMS (Mode 21~40): It is<br>intended to stimulate<br>healthy muscles in order<br>to improve and facilitate<br>muscle performance.<br>FITNESS (Mode 41~50):<br>Improvement of<br>abdominal tone,<br>strengthening of the<br>abdominal muscles<br>development of firmer<br>abdomen.<br>KTR-2211, KTR-2221,<br>KTR-2231 , KTR-2212,<br>KTR-2222 , KTR-2232 :<br>(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. | back, back of the neck,<br>arm, leg, and foot due<br>to strain from exercise<br>or normal household<br>work activities by<br>applying current to<br>stimulate nerve. | strain from exercise<br>or normal<br>household work<br>activities by<br>applying current to<br>stimulate nerve.<br>To be used for<br>symptomatic relief<br>and management of<br>chronic, intractable<br>pain and relief of<br>pain associated with<br>arthritis (Choose<br>Mode B or C).<br>To stimulate healthy<br>muscles in order to<br>improve and<br>facilitate muscle<br>performance<br>(Choose Mode A).<br>To temporarily<br>increase local blood | development<br>of firmer<br>abdomen.<br>Strengthening,<br>toning and<br>firming of<br>buttocks and<br>thighs. | | |
| Power Source(s) | DC 4.5V (3*AAA LR03<br>battery), 180mA | Adaptor Input 100-<br>240Vac, 50-60Hz,<br>0.1A<br>Output 5Vdc, 1A<br>Unit Input 5Vdc, 1A | DC 3.0V, 2 x AAA | Adapter<br>(Model<br>HDMU05E-<br>050100,<br>HDMU05B-<br>050100,<br>HDMU05U-<br>050100) Input<br>100-240 Vac;<br>50/60 Hz;<br>0.3A; | SE<br>Note 2 | |
| Elements of<br>Comparison | Subject Device | Primary Predicate<br>Device | Reference Device<br>1 | Reference<br>Device 2 | Remark | |
| | | | | | Output: 5 V;<br>1 A<br>Rechargeable<br>Lithium-ion<br>Battery:<br>3.7Vdc | |
| -Method of Line<br>Current Isolation | Type BF Applied Part | Type BF Applied Part | Type BF Applied Part | Type BF Applied Part | SE | |
| Patient<br>Leakage<br>Current | NC | DC: 0.5μA | AC: 54.5µA,<br>DC: 0.5μA | DC: 0.5µA | < 0 .01 µA | SE |
| | SFC | DC: 0.6μA | AC:120.0 µ A , DC:<br>0.6μA | DC: 0.6μA | 0.1mA | |
| Average DC<br>current through<br>electrodes when<br>device is on but<br>no pulses are<br>being applied | | < 0 .01 µA | < 0 .01μA | < 0 .01 | Not publicly<br>available | SE |
| Number of Output<br>Channel s: | | 2 channels | 2 | 2 | 2 | SE |
| Number of Output<br>Modes | | 50 | 25 | 3 | 8 | SE<br>Note 3 |
| Output Intensity<br>Level | | 16 steps | 99 steps | 5 steps | Not publicly<br>available | SE<br>Note 3 |
| Synchronous or<br>Alternating? | | Synchronous | Synchronous | Synchronous | Alternating | SE |
| Method of<br>Channel Isolation | | Voltage Transform<br>Isolation<br>"Ch1+" and "Ch1-"<br>buttons for channel 1,<br>"Ch2+" and "Ch2-"<br>buttons for channel 2, | Voltage Transform<br>Isolation<br>" BodyT" and " Body T"<br>buttons for body<br>channel, "Sole .& " and<br>"SoleT" buttons for<br>feet channel | Parallel connection | Voltage<br>Transform<br>Isolation | SE<br>Note 3 |
| Regulated<br>Current or<br>Regulated<br>Voltage? | | Voltage Control | Voltage Control | Parallel connection | Voltage<br>Control | SE |
| Elements of Comparison | Subject Device | Primary Predicate Device | Reference Device 1 | Reference Device 2 | Remark | |
| Software/Fi rmware/Microprocessor Control? | Yes | Yes | Yes | Yes | SE | |
| Automatic Overload Trip | No | No | No | No | SE | |
| Automatic No-Load Trip | No | No | No | No | SE | |
| Automatic Shut Off | Yes | Yes | Yes | Yes | SE | |
| User Override Control | Yes | Yes | Yes | Yes | SE | |
| Indicator Display | On/Off Status | Yes | Yes | Yes | Yes | SE |
| | Low Battery | No | No | No | Yes | SE |
| | Voltage/Current Level | Yes | Yes | Yes | Yes | SE |
| Timer Range | 15, 30, 45min | 25min | 10, 20, 40 min | 15 min | SE Note 3 | |
| Weight | KTR-2210, KTR-2211, KTR-2212: 76g<br>KTR-2220, KTR-2221, KTR-2222: 82g<br>KTR-2230, KTR-2231, KTR-2232: 75g<br>Electrode :12g<br>Electrode wire: 12g | 2Kg (Without accessories) | Main Unit:<br>P.T.S-11: 75g<br>P.T.S-IIA: 100g<br>P.T.S-11B: 100g<br>CP-I: 66g<br>Electrode:<br>Big Patch Electrode: 40g<br>Small Patch Electrode:10g<br>Insole Electrode: 200g<br>Sole Plant Electrode A (only for CP-I): 900g<br>Sole Plant | 80g (Without accessories) | SE Note 4 | |
| Elements of<br>Comparison | Subject Device | Primary Predicate<br>Device | Reference Device<br>1 | Reference<br>Device 2 | Remark | |
| | | | Electrode B: 920g | | | |
| Dimensions | Main unit:<br>KTR 2210, KTR-2211,<br>KTR-2212:<br>122mm * 55mm *<br>21.8mm;<br>KTR-2220 , KTR-2221 ,<br>KTR-2222 , KTR-2230 ,<br>KTR-2231 and KTR-<br>2232:<br>120mm * 55mm *<br>20.4mm<br>Electrode:<br>Square shape: 50mm x<br>50mm (Area: 25cm $^{2}$ )<br>Irregularly shape: about<br>50mm x 70mm (Area:<br>about 30cm $^{2}$ ) | 428mm x 428.8mm x<br>185mm | Main Unit:<br>P.T.S-11: 110 x 78 x<br>20mm<br>P.T.S-IIA: 135 x 82<br>x20 mm<br>P.T.S-IIB: 135 x 82<br>x20 mm<br>CP-I: 92 x 78 x 20<br>mm<br>Electrode:<br>Large Patch<br>Electrode: 120 x 80<br>mm<br>Small Patch<br>Electrode: 46 x 46<br>mm<br>Insole Electrode:<br>260 x 110 mm<br>Sole Plant<br>Electrode<br>A (only for CP-I):<br>450 x 450 x 90 mm<br>Sole Plant<br>Electrode B: 450 x<br>450 x 90 mm | Main Unit:<br>50X37mm<br>Electrode pad<br>for model AST-<br>301: 198mm x<br>164mm x 2mm<br>Electrode pad<br>for model AST-<br>302: 192mm x<br>164mm x 2mm<br>Electrode pad<br>for model AST-<br>303: 125 mm x<br>80mm x2mm<br>Each gel sheet<br>90mm x60mm<br>x2mm | SE<br>Note 4 | |
| Housing Materials<br>and Construction | Mam urnt: ABS plastic | Main unit: ABS plastic | Main unit: ABS<br>plastic…