(90 days)
No
The device description and performance studies focus on standard electrical stimulation technology and regulatory compliance, with no mention of AI or ML algorithms, data sets, or performance metrics typically associated with such technologies.
Yes.
The device is specifically designed for therapeutic purposes, as indicated by its intended use for temporary relief of pain and to stimulate muscles to improve performance.
No
The device is designed for therapeutic purposes (pain relief and muscle stimulation) rather than for diagnosing a medical condition.
No
The device description clearly outlines hardware components such as a portable device with a battery, buttons, a display screen, electrode cables, and a Type-C cable. It also mentions electrical safety and EMC standards testing, which are relevant to hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for pain relief and muscle stimulation. These are therapeutic applications, not diagnostic ones.
- Device Description: The description details a device that delivers electrical pulses to the body via electrodes. This is consistent with a TENS/EMS device, not an IVD which would typically involve analyzing biological samples (blood, urine, etc.).
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information about a disease or condition.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not perform any of these functions.
N/A
Intended Use / Indications for Use
TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities. EMS: The device is designed to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Product codes (comma separated list FDA assigned to the subject device)
NUH, NGX
Device Description
Transcutaneous Electrical Nerve Stimulator is a portable and DC 3.7V battery powered multifunction device that adopts modern electronic science and technology to delivers electric pulses generated to the electrodes. It has two functions: Transcutaneous electrical nerve stimulation(TENS) and Electrical muscle stimulation (EMS).
The device has 20 operation programs. It includes operating elements of Power ON/OFF button, intensity decrease button, Menu selection button, and A/B channel selection button.
The display screen can show battery power, program, mode, keylock status, intensity level, treatment time and output channel. The device is equipped with accessories of electrode cables, and one Type-C cable. The electrode cables are used to connect the pads to the device; the Type-C cable is used to connect the charger and the built-in lithium battery.
In additional, according to different simulation-needed bodies, users can choose the three types of electrode pad based on their own situation. The electrode pads are manufactured by ShenZhen Technology Co., Ltd with 510(k) cleared Number K171381.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Test Conclusion
The Transcutaneous Electrical Nerve Stimulator comply with the following Electrical & Thermal Safety, and Electromagnetic Compatibility standards:
-
IEC 60601-1:2005+A1:2012+A2:2020 Medical Electrical Equipment - Part 1: General Requirements for Safety
-
IEC 60601-2-10:2012+A1:2016, Medical electrical equipment - Part 2-10: Particular requirements for the saled muscle stimulators
3.IEC 60601-1-2:2014+A1:2020 , Medical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests, 2007
- IEC 60601-11:2015 , Medical electrical equipments for basic safety and essential performancecollateral standard: requirements for medical electrical systems used in the home healthcare environment.
FDA software validation guidance "General Principles of Software Validation; Final Guidance for Industry and FDA Staff, Document issued on: January 11, 2002".
Guidance Document for Powered Muscle Stimulator 510(k)s Document issued on: June 9, 1999
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K171803, K192264, K201354, K191151
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
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.(b)
Classification. Class II (performance standards).
0
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.
July 22, 2024
Shenzhen Yicai Health Technology Co., Ltd. Xie Jie General Manager 11th floor, Zhenqian Building, Yousong Community, Longhua Street, Longhua District Shenzhen, 518110 China
Re: K241119
Trade/Device Name: Transcutaneous Electrical Nerve Stimulator (K6106) Regulation Number: 21 CFR 882.5890, 21 CFR 890.5850 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: April 22, 2024 Received: April 23, 2024
Dear Xie Jie:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).
2
Sincerely,
Robert Kang -S
for 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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Transcutaneous Electrical Nerve Stimulator (K6106)
Indications for Use (Describe)
TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities. EMS: The device is designed to be used 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)
| 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."
4
| 510(k) Summary | Prepared on: 2024-07-11 | |
|---|---|---|
| Contact Details | 21 CFR 807.92(a)(1) | |
| Applicant Name | Shenzhen Yicai Health Technology Co., Ltd. | |
| Applicant Address | 11th floor, Zhenqian Building, Yousong Community, Longhua Street, | |
| Longhua District Shenzhen 518110 China | ||
| Applicant Contact Telephone | +86 13682320556 | |
| Applicant Contact | Mr. Xie Jie | |
| Applicant Contact Email | mdc-fs@foxmail.com | |
| Device Name | 21 CFR 807.92(a)(2) | |
| Device Trade Name | Transcutaneous Electrical Nerve Stimulator (K6106) | |
| Common Name | Transcutaneous electrical nerve stimulator for pain relief | |
| Classification Name | Stimulator, Nerve, Transcutaneous, Over-The-Counter | |
| Regulation Number | 882.5890 | |
| Product Code(s) | NUH, NGX |
Legally Marketed Predicate Devices
Predicate Trade Name (Primary Predicate is listed first) Predicate # Product Code K171803 HIVOX OTC Electrical Stimulator NUH HIVOX Spopad EMS K192264 NGX TENS & PMS K201354 NUH K191151 JKH Stimulator Plus NUH
Device Description Summary
Transcutaneous Electrical Nerve Stimulator is a portable and DC 3.7V battery powered multifunction device that adopts modern electronic science and technology to delivers electric pulses generated to the electrodes. It has two functions: Transcutaneous electrical nerve stimulation(TENS) and Electrical muscle stimulation (EMS).
The device has 20 operation programs. It includes operating elements of Power ON/OFF button, intensity decrease button, Menu selection button, and A/B channel selection button.
The display screen can show battery power, program, mode, keylock status, intensity level, treatment time and output channel. The device is equipped with accessories of electrode cables, and one Type-C cable. The electrode cables are used to connect the pads to the device; the Type-C cable is used to connect the charger and the built-in lithium battery.
In additional, according to different simulation-needed bodies, users can choose the three types of electrode pad based on their own situation. The electrode pads are manufactured by ShenZhen Technology Co., Ltd with 510(k) cleared Number K171381.
Intended Use/Indications for Use
TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.
21 CFR 807.92(a)(4)
21 CFR 807.92(a)(3)
21 CFR 807.92(a)(5)
5
EMS: The device is designed to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Indications for Use Comparison
The subject device has the same indications for use as the predicate devices as below:
TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.
EMS: The device is designed to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Technological Comparison
21 CFR 807.92(a)(6)
21 CFR 807.92(a)(5)
See Comparison Table on pg. 4 below.
Note 1
Dimension / Weight / Electrode area would be different device design in internal circuit and components choosing, which won't affect the safety and effectiveness, so it can deem as the substantially equivalence. The design of the intended use. For the subject device, the user could adjust the time based on user's included in predicate device. Note 2
The subject device has 20 output modes while the predicate devices have 50 or 15 output modes. All of the treatment programs of the subject device have passed the IEC 60601-2-10 and AAM / ANSI ES60601-1 test. So this difference doesn't raise any safety or effectiveness issue.
Note 3
Although the "Waveform", "Maximum Output Current" of the subject device are a little different from the predicate devices, the ranges are included in predicate device and they all comply with the requirements of IEC 60601-1 and IEC 60601-2-10 standard, as well as the Guidance for Powered Muscle Conditioning. So these differences will not raise any safety or effectiveness issue.
Note 4
Frequency and pulse width is the time parameter of the waveform. There is only little difference between the Frequency and Pulse width of the subject device, which is in the range of predicate devices comply with IEC 60601-1, and IEC60601-2-10, which means we have proved its safety as well as the effectiveness comparing with the predicate device and predicate device are substantially equivalence on these parameters.
Note 5
Although the "Maximum Phase Charge", "Maximum Current Density", "Maximum Average Current", and "Maximum Power Density" of the subject device is a little different from the predicate device in predicate device and they all comply with the requirements of IEC 60601-1 and IEC 60601-2-10 standard. Besides, the maximum power density meets with the maximum allowed value 0.25 (W/cm²) required in FDA guidance. Therefore, the subject device are substantially equivalence on these
් NoneElinical and/or Clinical Tests Summary & Conclusions
Non-Clinical Test Conclusion
The Transcutaneous Electrical Nerve Stimulator comply with the following Electrical & Thermal Safety, and Electromagnetic Compatibility standards:
-
IEC 60601-1:2005+A1:2012+A2:2020 Medical Electrical Equipment - Part 1: General Requirements for Safety
-
IEC 60601-2-10:2012+A1:2016, Medical electrical equipment - Part 2-10: Particular requirements for the saled muscle stimulators
3.IEC 60601-1-2:2014+A1:2020 , Medical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests, 2007
- IEC 60601-11:2015 , Medical electrical equipments for basic safety and essential performancecollateral standard: requirements for medical electrical systems used in the home healthcare environment.
FDA software validation guidance "General Principles of Software Validation; Final Guidance for Industry and FDA Staff, Document issued on: January 11, 2002".
Guidance Document for Powered Muscle Stimulator 510(k)s Document issued on: June 9, 1999
6
Conclusions
The electrical safety, EMC, biocompatibility, software verification, and output specifications information provided is sufficient to demonstrate substantial equivalence to the Transcutaneous Electrical Nerve Stimulator, model: K6106 is nearly identical to the predicate devices, differences in their characteristics do not raise new questions regarding safety and effectiveness with identical indications for use and essentially identical technological characteristics, the Transcutaneous Electrical Nerve Stimulator, model: K6106 is substantially equivalent to the predicate devices.
7
File No.: Substantial Equivalence Comparison
Substantial Equivalence Comparison
The technological characteristics, features, specifications, materials, and intended use of TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR is substantially equivalent to the predicate devices quoted below. 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 (Primary) | Reference Device | Reference Device | Reference Device | Comparison |
|---|---|---|---|---|---|---|
| Manufacturer | Shenzhen Yicai Health | |||||
| Technology Co., Ltd. | HIVOX BIOTEK INC. | Hivox Biotek | ||||
| Inc. | Hong Qiangxing | |||||
| (Shenzhen) Electronics | ||||||
| Limited | JKH USA, LLC | -- | ||||
| 510 (k) Number | - | K171803 | K192264 | K201354 | K191151 | -- |
| Product Name | Transcutaneous Electrical | |||||
| Nerve Stimulator | HIVOX OTC Electrical | |||||
| Stimulator | HIVOX | |||||
| Spopad EMS | TENS & PMS | JKH Stimulator | ||||
| Plus | -- | |||||
| Models | K6106 | SEM44, SEM44-1, | SP-911, SP-921 | SM9196 | PL-029K5BL | -- |
| Product code | NUH, NGX | NUH, NGX | NGX | NUH, NGX | NUH, NGX, NYN, | |
| GZJ, IPF, IRT | Same | |||||
| Regulation number | 21 CFR 882.5890 | |||||
| 21 CFR 890.5850 | 21 CFR 882.5890 | |||||
| 21 CFR 890.5850 | 21 CFR 890.5850 | 21 CFR 882.5890 | ||||
| 21 CFR 890.5850 | 21 CFR 882.5890 | |||||
| 21 CFR 890.5850 | Same | |||||
| Prescription/ OTC | OTC | OTC | OTC | OTC | OTC | Same |
| File No.: | Substantial Equivalence Comparison | |||||
| Intended Use | TENS: The device is | |||||
| designed to be used for | ||||||
| temporary relief of pain | ||||||
| associated with sore and | ||||||
| aching muscles in the | ||||||
| shoulder, waist, back, | ||||||
| neck, upper extremities | ||||||
| (arm), lower extremities | ||||||
| (leg), abdomen and | ||||||
| bottom due to strain from | ||||||
| exercise or normal | ||||||
| household work activities. | ||||||
| EMS: The device is | ||||||
| designed to be used to | ||||||
| stimulate healthy | ||||||
| muscles in order to | ||||||
| improve and facilitate | ||||||
| muscle performance. | SEM44 – | |||||
| TENS: The device is | ||||||
| designed to be used for | ||||||
| temporary relief of pain | ||||||
| associated with sore and | ||||||
| aching muscles in the shoulder, | ||||||
| waist, back, neck, | ||||||
| upper extremities (arm), lower | ||||||
| extremities (leg), | ||||||
| abdomen and bottom due to | ||||||
| strain from exercise or normal | ||||||
| household work activities. | ||||||
| EMS: The device is designed to | ||||||
| be used for stimulate healthy | Indicated for the | |||||
| improvement of muscle | ||||||
| tone and firmness, for | ||||||
| strengthening muscles in | ||||||
| arms, abdomen, thighs, | ||||||
| and buttocks areas. | ||||||
| Not intended for use in | ||||||
| any | ||||||
| therapy or for the | ||||||
| treatment of any medical | ||||||
| conditions or diseases. | TENS(10~15): | |||||
| To be used for temporary | ||||||
| relief of pain associated | ||||||
| with sore and aching | ||||||
| muscles in the shoulder, | ||||||
| waist, back, neck, upper | ||||||
| extremities (arm), and | ||||||
| lower extremities (leg) due | ||||||
| to strain from exercise or | ||||||
| normal household work | ||||||
| activities. | ||||||
| PMS(1~9): | ||||||
| It is intended to be used to | ||||||
| stimulate healthy muscles | TENS: PL-029K5BL, | |||||
| PL-029K15, and PL- | ||||||
| 029I are used for | ||||||
| temporary relief of | ||||||
| pain associated with | ||||||
| sore and aching | ||||||
| muscles in the | ||||||
| shoulder, waist, back, | ||||||
| arm, and leg, due | ||||||
| to strain from exercise | ||||||
| or normal household | ||||||
| and work activities | ||||||
| PL-029K5BL, PL- | ||||||
| 029K15, and PL- | ||||||
| 029T are also | ||||||
| intended for | Same | |||||
| muscles in order to improve and | ||||||
| facilitate muscle performance. | ||||||
| SEM44-1 – | ||||||
| TENS: The device is designed | ||||||
| to be used for temporary relief | ||||||
| of pain associated with sore and | ||||||
| aching muscles in the shoulder, | ||||||
| waist, back, neck, upper | ||||||
| extremities (arm), lower | ||||||
| extremities (leg), abdomen and | ||||||
| bottom due to strain from | ||||||
| exercise or normal household | ||||||
| work activities. | in order to improve and | |||||
| facilitate muscle | ||||||
| performance. | symptomatic relief | |||||
| and management of | ||||||
| chronic, intractable | ||||||
| pain and relief of pain | ||||||
| associated with | ||||||
| arthritis | ||||||
| The device of PL- | ||||||
| 029K5BL and PL- | ||||||
| 029K15 may be used | ||||||
| during sleep. The | ||||||
| device of PL- | ||||||
| 029K5BL and PL- | ||||||
| 029K15 labeled for | ||||||
| use only with its own | ||||||
| compatible electrodes | ||||||
| PMS | ||||||
| PL-029K5BL, PL- | ||||||
| 029K 15, and PL- | ||||||
| 029T are used to | ||||||
| stimulate healthy | ||||||
| muscles in order to | ||||||
| improve and facilitate | ||||||
| muscle | ||||||
| performance. To | ||||||
8
Subject Device:
TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR , Model: K6106 Substantial Equivalence Comparison
9
Sponsor: Shenzhen Yicai Health Technology Co., Ltd.
Subject Device:
TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR , Model: K6106
| File No.: | Substantial Equivalence Comparison | ||
|---|---|---|---|
| be used for the | |||
| improvement of | |||
| muscle tone and | |||
| firmness , and for | |||
| strengthening | |||
| muscles in the | |||
| arms abdomen , | |||
| legs , and buttocks | |||
| . Not intended for | |||
| use in any therapy | |||
| or for the treatment | |||
| of any medical | |||
| conditions for | |||
| diseases |
PL-029K5BL , PL-
029K15 and PL-
029T are also
intended to
temporarily
increase local
blood circulation in
the healthy
muscles of lower
extremities | |
10
Subject Device: TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR , Model: K6106
File No.: Substantial Equivalence Comparison
| File No.. Substantial Equivalence Comparison | |||||||
|---|---|---|---|---|---|---|---|
| Power Supply | Internal battery: 3.7Vd.c. | ||||||
| 300mAh | 4.5V (batteries, 3x1.5V | ||||||
| AAA) | 3 V battery × 1 | DC 3.7V lithium battery | Rechargeable or | ||||
| non-rechargeable | |||||||
| battery | Same | ||||||
| Method of Line Current | |||||||
| Isolation | Type BF | N/A | Battery supply | Type BF | Battery Supply | Same | |
| Size (L x W x H) | 118mm x 65mm x 20mm | 132 x 63 x 29.5 mm (including | |||||
| belt clip) | 8.15 x 4.06 x0.51 inch | 180mm x 58mm x 15.5mm | PL-029K5BL: | ||||
| 66x56x18mm | Similar | ||||||
| Note 1 | |||||||
| Weight(g) | 110 g / 0.24 lb | 89 g (including belt clip, without | |||||
| batteries), 123 g (including belt | |||||||
| clip and batteries) | 24.2 g | 100g±5g | PL-029K5BL: 40g | Similar | |||
| Note 1 | |||||||
| Patient Leakage | |||||||
| Current | |||||||
| Normal Condition | |||||||
| (μΑ) |