Masimo Stork

K223721 · Masimo Corporation · DQA · Dec 15, 2023 · Cardiovascular

Device Facts

• Record ID: K223721
• Device Name: Masimo Stork
• Applicant: Masimo Corporation
• Product Code: DQA · Cardiovascular
• Decision Date: Dec 15, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Masimo Stork is a wearable device intended for the monitoring of multiple physiological parameters. Masimo Stork is intended to be used in home environments. The Masimo Stork is indicated for the spot-checking and continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate (PR) in infants and neonates during no-motion, motion, and low perfusion conditions. The Masimo Stork is also indicated for continuous skin temperature measurements of infants and neonates.

Device Story

Wearable device for infants/neonates; monitors SpO2, pulse rate, and skin temperature. Input: optical signals (red/infrared light) via foot-worn sensor; thermistor for temperature. Signal processing module (Masimo SET technology) calculates parameters; data transmitted via Bluetooth to Hub and mobile App. Hub provides local alarms/charging; App provides user interface/trends; Cloud stores data. Used in home environment by parents/caregivers. Output: real-time physiological data, trend views, and audible/visual alarms. Benefits: continuous remote monitoring, early notification of abnormal vital signs, and improved detection of arterial signals during motion/low perfusion.

Clinical Evidence

Three clinical studies: 1) Desaturation study (n=30) comparing Stork to RD SET sensor (K191059) per ISO 80601-2-61; 2) Performance study (n=41) comparing Stork SpO2 to FDA-cleared oximeter across diverse skin pigmentations/ages; 3) Overnight home-use study (n=19) evaluating safety, prolonged use, and alarm performance (99.7% availability under low motion).

Technological Characteristics

Thermoplastic enclosure; reusable sensor boot; thermistor for temperature; pulse oximetry via spectrophotometry/photoplethysmography. Wireless connectivity (Bluetooth/Wi-Fi) with encryption. Class II, internally powered (Li-ion battery), BF applied part, IP22. Software-based signal processing (Masimo SET).

Indications for Use

Indicated for infants and neonates (<18 months) for spot-checking and continuous monitoring of SpO2, pulse rate, and skin temperature in home environments. Supports monitoring during no-motion, motion, and low perfusion conditions.

Regulatory Classification

Identification

An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.

Predicate Devices

• Guardian Angel Rx GA2000 Series Digital Vital Signs Monitoring System (K203208)

Reference Devices

• Masimo Rad-97 and Accessories including RD SET Adhesive sensors (K191059)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for 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 text logo on the right. The FDA text logo is in blue and includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION".

December 15, 2023

Masimo Corporation Sindura Penubarthi Associate Director, Regulatory Affairs 52 Discovery Irvine, California 92618

### Re: K223721

Trade/Device Name: Masimo Stork Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA, FLL Dated: October 2, 2023 Received: October 4, 2023

Dear Sindura Penubarthi:

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" (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).

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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 QS 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

## Bradley Q. Quinn -S

Bradley Quinn Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Enclosure

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### Indications for Use

510(k) Number (if known) K223721

Device Name

Masimo Stork

Indications for Use (Describe)

The Masimo Stork is a wearable device intended for the monitoring of multiple physiological parameters. Masimo Stork is intended to be used in home environments.

The Masimo Stork is indicated for the spot-checking and continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate (PR) in infants and neonates during no-motion, and low perfusion conditions.

The Masimo Stork is also indicated for continuous skin temperature measurements of infants and neonates.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------|---------------------------------------------|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/4/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in black, bold font. To the right of the company name is the company address, which is "52 Discovery, Irvine, CA 92618".

| Submitter and Address of<br>Manufacturing Facility: | Masimo Corporation<br>52 Discovery<br>Irvine, CA 92618<br>Phone: [phone]<br>FAX: [phone] |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Date: | December 15, 2023 |
| Contact: | Sindura Penubarthi<br>Associate Director, Regulatory Affairs<br>Masimo Corporation<br>Phone: [phone] |
| Trade Name: | Masimo Stork |
| Common Name: | Oximeter |
| Classification Regulation/<br>Product Code: | 21 CFR 870.2700, Class II/DQA |
| Additional Product Code: | FLL |
| Establishment Registration<br>Number: | 3011353843 |
| Reason for Premarket<br>Notification: | New Device |
| Predicate Device: | K203208 – Guardian Angel Rx GA2000 Series Digital Vital<br>Signs Monitoring System |
| Reference Device: | K191059 - Masimo Rad-97 and Accessories including RD SET<br>Adhesive sensors |

### 1. Device Description

The Masimo Stork is a wearable device that is applied to a baby's foot for the spot-checking and continuous monitoring of functional arterial oxygen saturation (SpO2), pulse rate (PR), and skin temperature. Masimo Stork is provided with wireless communication capabilities (e.g., Bluetooth) so that the parameter data can be communicated for monitoring (e.g., display, alarms).

The Stork combines the signal processing and optical components (i.e., signal detecting parts) into a single pulse oximetry module. The module is flat to allow for the flush contact with a baby (e.g., neonate, infant) foot.

Masimo Stork can be used with following components:

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Image /page/5/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in bold, black letters. To the right of the word "Masimo" is the text "MASIMO CORPORATION" in gray, followed by the address "52 Discovery, Irvine, CA 92618" also in gray.

- 1. Stork Boot ("Boot") is a silicone holder that helps in the placement and securement of the Stork on to the baby's foot.
- 2. Stork Hub ("Hub") is an alarm/ connectivity device that helps in the communication of the physiological data wirelessly from Stork to a software application. The Hub provides the charging of the Stork and can optionally be provided with a camera.
- 3. Stork App ("App") is mobile device application that is connected through the Hub and/or directly to the Stork to provide the user interface for viewing and monitoring the physiological parameters.
- 4. Stork Cloud ("Cloud") is the software that helps to store the physiological data. It also helps to monitor the wireless connections between the Hub, App, and Stork.

The Masimo Stork specifications are as follows:

| Masimo Stork | |
|----------------------------------------------|-----------------------------------|
| Feature | Specifications |
| Remote Access to Monitored Data | Yes |
| Support Communication Types | Wireless |
| Wireless Protocols Supported | Bluetooth, Wi-Fi |
| Communication Security | Encryption |
| Continuous Display of Parameter Data | Yes |
| Supported Display Devices | Smart Device |
| User Interface | Touchscreen (Smart Device) |
| Performance Specifications | |
| SpO2, No Motion (70-100%) | 1.5% |
| SpO2, Motion (70-100%) | 1.5% |
| SpO2, Low Perfusion (70-100%) | 2% |
| Pulse Rate, No Motion (25-240 bpm) | 3 bpm |
| Pulse Rate, Motion (25-240 bpm) | 5 bpm |
| Pulse Rate, Low Perfusion (25-240 bpm) | 3 bpm |
| Temperature [25°C to 43°C (77°F to 109.4°F)] | $\pm 0.3°C (\pm 0.54°F)$ |
| Electrical Specifications | |
| Battery Type | Internal Rechargeable Lithium ion |
| Environmental Specifications | |
| Operating Temperature | 32°F to 104°F (0°C to 40°C) |
| Operating Humidity | 10% to 95%, non-condensing |
| Storage/Transport Temperature | -4°F to 140°F (-20°C to 60°C) |
| Storage/Transport Humidity | 10% to 95%, non-condensing |
| | Classification per IEC 60601-1 |
| Electrical Safety | IEC 60601-1 |
| EMC | IEC 60601-1-2 |
| Electrical Isolation Type | Class II (Internally Powered) |
| Applied Part Type | BF Applied Part |
| Ingress Protection | IP22 |
| Mode of Operation | Continuous |

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Image /page/6/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in a bold, sans-serif font. To the right of the logo is the text "MASIMO CORPORATION" in a smaller, sans-serif font, followed by the address "52 Discovery, Irvine, CA 92618".

| Masimo Hub | |
|-------------------------------|-----------------------------------|
| Feature | Specifications |
| Electrical Specifications | |
| Types of Power Source | AC |
| AC Electrical Power Rating | 100 to 240 VAC, 50 to 60 Hz, 0.2A |
| Environmental Specifications | |
| Operating Temperature | 41°F to 95°F (5°C to 35°C) |
| Operating Humidity | 10% to 95%, non-condensing |
| Storage/Transport Temperature | -4°F to 140°F (-20°C to 60°C) |
| Storage/Transport Humidity | 10% to 95%, non-condensing |

### 2. Intended Use/ Indications for Use

The Masimo Stork is a wearable device intended for the monitoring of multiple physiological parameters. Masimo Stork is intended to be used in home environments.

The Masimo Stork is indicated for the spot-checking and continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate (PR) in infants and neonates during nomotion, motion, and low perfusion conditions.

The Masimo Stork is also indicated for continuous skin temperature measurements of infants and neonates.

### 3. Technological Characteristics

### Principle of Operations

The subject device. Masimo Stork, utilizes the same principles of operation as other FDA cleared Masimo SET pulse oximetry devices. Masimo SET pulse oximetry relies on the Beer-Lambert law and the following principles of pulse oximetry to provide estimates of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate:

- . Oxyhemoglobin (oxygenated blood) and deoxyhemoglobin (non-oxygenated blood) differ in their absorption of red and infrared light (spectrophotometry).
- The amount of arterial blood in tissue changes with your pulse (photoplethysmography). ● Therefore, the amount of light absorbed by the varying quantities of arterial blood changes as well.

These principles of operation are combined with the use of advanced signal processing algorithms as part of the FDA cleared Masimo SET pulse oximetry technology to help to minimize the impact of confounding factors, such as static absorbers (e.g., skin pigmentation, site thickness differences). The advanced signal processing features allow for better detection of the arterial signal.

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Image /page/7/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in a bold, sans-serif font. To the right of the word "Masimo" is the text "MASIMO CORPORATION" in a smaller, sans-serif font, followed by the address "52 Discovery, Irvine, CA 92618".

The Masimo Stork also provides a skin temperature monitoring feature that relies on the principle of operations of a thermistor.

### Mechanism of Action for Achieving the Intended Effect

The Masimo Stork achieves its intended effect by the application on to the baby's foot. To keep the Stork in place, a bootie shaped holder is provided that secures the sensors in place. The Stork provides wireless capabilities so that a cabled connection is not required to transmit the parameters measurements continuously. The wireless communication is established by a paired Bluetooth connection to support alarms and display. To support the parameter data monitored by the Stork, a smart device software application is used as a user interface. The software application displays the parameter data and provides notifications of alarm conditions. The software application (App) also allows for the viewing of parameter trend information. The Hub that is used with the Stork is provided with an integrated speaker and visual indicators to also notify of alarm conditions independent of the App. The Hub provides redundancy in the event the smart device battery is depleted or the alarm notifications on the App are not detected.

### 4. Summary of Technological Characteristics of Subject Device Compared to Predicate Device

#### Similarities and Differences between Predicate and Subject Device

The subject device, Masimo Stork, and the predicate device, Guardian Angel (K203208), have the following key similarities:

- · Both devices have the same intended use;
- · Both devices are wearable;
- · Both devices support similar monitoring technologies (SpO2, PR, and Temperature);
- · Both devices utilize wireless capabilities to allow for data to be transmitted for remote display and monitoring using a software application;
- · Both devices provide audible and visual alarms.

The subject device, Masimo Stork, and the predicate device, Guardian Angel (K203208), have the following key differences:

- · The subject device monitors skin temperature on the baby's foot.
As part of the submission, data was provided to support both devices have the same intended use. Testing was also provided to support the substantial equivalence of the subject device.

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Image /page/8/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of the word "Masimo" in bold, black letters, with a red circle containing a white line to the left of the word. To the right of the logo is the text "MASIMO CORPORATION" followed by the address "52 Discovery, Irvine, CA 92618".

| Comparison between Subject and Predicate Device | | | |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | Masimo Stork<br>Subject Device | Guardian Angel Rx GA2101 Digital Vital Signs<br>Monitoring System<br>Predicate Device<br>(K203208) | Comparison to Predicate Device |
| Classification | Class II, Oximeter | Class II, Oximeter | Same. |
| Regulation,<br>Product Code | 21 CFR 870.2700, Class II/DQA | 21 CFR 870.2700, Class II/DQA | Same. |
| Additional<br>Product Code(s) | FLL | FLL | Same. |
| Intended Use | The Masimo Stork is a wearable device intended for the<br>monitoring of multiple physiological parameters. Masimo<br>Stork is intended to be used in home environments.<br><br>The Masimo Stork is indicated for the spot-checking and<br>continuous monitoring of functional oxygen saturation of<br>arterial hemoglobin (SpO2) and Pulse Rate (PR) in infants<br>and neonates during no-motion, motion, and low perfusion<br>conditions.<br><br>The Masimo Stork is also indicated for continuous skin<br>temperature measurements of infants and neonates. | The Guardian Angel Rx GA2000 Series Digital<br>Vital Sign Monitoring System (Model GA2101)<br>is indicated for use in measuring, recording, and<br>displaying functional oxygen saturation of arterial<br>hemoglobin (SpO2) and pulse rate (PR) and body<br>temperature. The intended environments of use<br>are hospitals medical facilities, home care, and<br>subacute environments. This system is a reusable<br>device. The Oximeter Module(s) is indicated for<br>spot checking and/or continuous monitoring of<br>SpO2 and PR of pediatrics and infants during<br>non-motion and under well perfused conditions.<br>The Thermometer Module is indicated for<br>continuous armpit body temperature monitoring<br>of pediatrics, and infants. | Same. |
| Principles of<br>Operation | The pulse oximeter technology relies on the absorption<br>differences of red and infrared light to determine SpO2<br>and Pulse Rate. | The pulse oximeter technology relies on the<br>absorption differences of red and infrared light to<br>determine SpO2 and Pulse Rate. | Same. |
| Comparison between Subject and Predicate Device | | | |
| Feature | Masimo Stork<br>Subject Device | Guardian Angel Rx GA2101 Digital Vital Signs<br>Monitoring System<br>Predicate Device<br>(K203208) | Comparison to Predicate Device |
| | Temperature measure relies on a thermistor that<br>correlates temperature to impedance changes. | Temperature measure relies on a thermistor that<br>correlates temperature to impedance changes. | |
| Parameters<br>Monitored | SpO2, PR, Temperature | SpO2, PR, Temperature | Same. |
| Supported<br>Display Devices | Smart Device App | Display Unit, Smart Device App | Similar. Both devices display<br>measurements on a smart device<br>app.<br>The predicate device also supports<br>the ability to display measurements<br>to a separate display unit.<br>Testing is provided to support the<br>display unit is not needed. |
| Pulse Oximeter<br>Sensor Type | Reusable | Reusable with Disposable Adhesives | Different. Subject device does not<br>use a disposable adhesive to secure<br>the sensor.<br>Testing is provided to support the<br>difference does not raise different<br>questions of safety and<br>effectiveness. |
| Temperature<br>Sensor Type | Reusable | Disposable | Different. Subject device is reusable.<br>Testing is provided to support the<br>difference does not raise different |
| Comparison between Subject and Predicate Device | | | |
| Feature | Masimo Stork<br>Subject Device | Guardian Angel Rx GA2101 Digital Vital Signs<br>Monitoring System<br>Predicate Device<br>(K203208) | Comparison to Predicate Device |
| Indicated<br>population | Infants, Neonates (<18 months) | Infants | questions of safety and<br>effectiveness.<br>Similar. Subject device covers wide<br>patient category aligned with<br>reference device.<br>Testing is provided to support the<br>performance on the wider<br>population. |
| Remote Access<br>to Monitored<br>Data | Yes | Yes | Same. |
| Supported<br>Alarms | SpO2, PR, and Temperature | SpO2, PR and Temperature | Same. |
| Type of Alarm | Audible and visual | Audible and visual | Same. |
| Distributed<br>Alarm System | Yes | Yes | Same. |
| Supported<br>Communication | Bluetooth, Wi-Fi | Bluetooth, Wi-Fi | Same. |
| Communication<br>Security | Encryption | Unknown | Subject device provides encrypted<br>communication. |
| Pulse Oximetry<br>Sensor<br>Application Site | Foot | Foot | Same. |
| Comparison between Subject and Predicate Device | | | |
| Feature | Masimo Stork<br>Subject Device | Guardian Angel Rx GA2101 Digital Vital Signs<br>Monitoring System<br>Predicate Device<br>(K203208) | Comparison to Predicate Device |
| SpO2, No<br>Motion (70-<br>100%) | 1.5% | 3% | Different. Subject device includes<br>improved performance specification<br>similar to reference device RD SET<br>Adhesive Sensor (K191059). |
| SpO2, Motion<br>(70-100%) | 1.5% | No motion only | Different. Subject device includes<br>improved performance specification<br>similar to reference device RD SET<br>Adhesive Sensor (K191059). |
| SpO2, Low<br>Perfusion (70-<br>100%) | 2% | Well perfused only | Different. Subject device includes<br>improved performance specification<br>similar to reference device RD SET<br>Adhesive Sensor (K191059). |
| Pulse Rate, No<br>Motion | Range: 25-240 bpm, 3 bpm Arms | Range: 30-290 bpm, 3 bpm Arms | Different. Subject device supports a<br>different specification range.<br>Testing provided to support the<br>performance across the specification<br>range. |
| Pulse Rate,<br>Motion | Range: 25-240 bpm, 3 bpm Arms | No motion only | Different. Subject device supports a<br>different specification range.<br>Testing provided to support the<br>performance across the specification<br>range. |
| Pulse Rate, Low<br>Perfusion | Range: 25-240 bpm, 3 bpm Arms | Well perfused only | Different. Subject device supports a<br>different specification range. |
| Comparison between Subject and Predicate Device | | | |
| Feature | Masimo Stork<br>Subject Device | Guardian Angel Rx GA2101 Digital Vital Signs<br>Monitoring System<br>Predicate Device<br>(K203208) | Comparison to Predicate Device |
| Temperature,<br>Measurement<br>Accuracy | +/- 0.3°F | +/- 0.2°F | Testing provided to support the<br>performance across the specification<br>range.<br>Different. The subject device has a<br>different claimed accuracy. |
| Temperature<br>Measurement<br>Site | Foot | Axillary | Testing is provided to support the<br>performance specification<br>Different. Subject device has<br>different application site. |
| Enclosure<br>Material | Thermoplastic | Thermoplastic…