← Product Code [GXY](/productcode/GXY) · K262654

# Dexus Prosthetic System (MSL2, MSR2) (K262654)

_Zhejiang Qiangnao Technology Co.,Ltd · GXY · Aug 27, 2026 · Neurology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K262654

## Device Facts

- **Applicant:** Zhejiang Qiangnao Technology Co.,Ltd
- **Product Code:** [GXY](/productcode/GXY.md)
- **Decision Date:** Aug 27, 2026
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 882.1320
- **Device Class:** Class 2
- **Review Panel:** Neurology
- **Attributes:** Therapeutic

## Indications for Use

The Dexus Prosthetic System is to be used exclusively for external prosthetic fittings of the upper limbs.

## Device Story

Powered upper limb prosthetic system; utilizes surface EMG electrodes to detect neural myoelectric signals from skin; signals processed via internal algorithms to control prosthetic hand movements; 6 degrees of freedom; supports multiple grasp patterns (e.g., tripod pinch, hook, lateral pinch); functions switched via buttons on back of hand. Installed by trained prosthetists for single-patient use in home or clinical settings. Benefits patients by restoring functional grasp and facilitating daily activities. Not for use in sports, motor vehicle operation, or heavy machinery.

## Clinical Evidence

No clinical data. Safety and performance established via bench testing, including electrical safety (IEC 60601-1 series), electromagnetic compatibility (IEC 60601-1-2), battery safety (IEC 62133-2), and biocompatibility (ISO 10993-5/10).

## Technological Characteristics

Powered prosthetic hand with 6 DOF; EMG signal acquisition (80-500 Hz bandwidth); Li-ion battery (7.2V, 3000mAh). Materials: Polycarbonate (PC2858), Thermoplastic Elastomer (TM5ADT), copper-plated metal contacts. Software-controlled; no wireless communication. Operating temp: +5°C to +40°C. Sterilization not specified; assembly via suction socket.

## Regulatory Identification

A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.

## Predicate Devices

- Dexus Prosthetics System ([K220002](/device/K220002.md))

## Submission Summary (Full Text)

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**FDA U.S. FOOD & DRUG**
ADMINISTRATION

August 27, 2026

Zhejiang Qiangnao Technology Co.,Ltd
% Cassie Lee
Official Correspondent
Share Info (Guangzhou) Medical Consultant , Ltd.
# 1919-1920, Bldg. D3, Minjie Plz., Shuixi Rd.,
Huangpu District
Guangzhou, Guangdong 510000
China

Re: K262654

Trade/Device Name: Dexus Prosthetic System (MSL2, MSR2)

Regulation Number: 21 CFR 882.1320

Regulation Name: Cutaneous Electrode

Regulatory Class: Class II

Product Code: GXY, IQZ

Dated: July 29, 2026

Received: July 30, 2026

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 (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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K262654 - Cassie Lee

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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).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

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 (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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K262654 - Cassie Lee

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

# Tushar Bansal -S

Tushar Bansal, PhD

Acting Assistant Director, Acute Injury Devices Team

DHT5B: Division of Neuromodulation and

Rehabilitation 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  |   |   |
| --- | --- | --- |
|  Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K262654 | ?  |
|  Please provide the device trade name(s). |   | ?  |
|  Dexus Prosthetic System (MSL2, MSR2)  |   |   |
|  Please provide your Indications for Use below. |   | ?  |
|  The Dexus Prosthetic System is to be used exclusively for external prosthetic fittings of the upper limbs.  |   |   |
|  Please select the types of uses. | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ?  |
|  Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ?  |

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# 510(k) Summary

K262654

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 801.92.

## 1. Submitter's Information

510(k) Owner's Name: Zhejiang Qiangnao Technology Co.,Ltd

Establishment Registration Number: Applying

Address: Room 201-5, Building 1, No.1818-2, Wenyi West Road, Yuhang Street, Yuhang District, Hangzhou, Zhejiang, China

Tel: +(86) 15730283327

Contact Person: Guifang Dai

E-mail: guifang.dai@brainco.cn

## Application Correspondent:

Contact Person: Cassie Lee

Company: Share Info (Guangzhou) Medical Consultant Ltd.

Address: No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District, Guangzhou, China

Tel: +86 20 8266 2446

E-mail: 382198657@qq.com

**Date of the summary prepared: August 26, 2026**

## 2. Subject Device Information

Type of 510(k): Traditional

Common Name: Powered, External Upper Limb Prosthetic System

Classification Name: Cutaneous electrode

Trade Name: Dexus Prosthetics System

Model Name: MSL2, MSR2

Review Panel: Neurology

Product Code: GXY, IQZ

Regulation Number: 21 CFR 882.1320

Regulatory Class: II

## 3. Manufacturer's Legally marketed device information

Sponsor: Zhejiang Qiangnao Technology Co.,Ltd.

Trade Name: Dexus Prosthetics System

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Model: MSL1, MSR1

Common Name: Powered, External Upper Limb Prosthetic System

Classification Name: Cutaneous electrode

510(K) Number: K220002

Review Panel: Neurology

Product Code: GXY, IQZ

Regulation Number: 21 CFR 882.1320

Regulation Class: II

#### 4. Device Description

The Dexus Prosthetic System is to be used exclusively for external prosthetic fittings of the upper limbs. This Dexus Prosthetic System is suitable for upper limb disabled groups (wrist disarticulated, forearm amputated, congenital missing hand, etc.), for upper limb amputees to compensate or make up for some of the functions of the amputated limb. It applies to the neural myoelectric signal collected from the skin's surface to realize the control of the upper limb prosthetic device. The collected neural myoelectric signal are processed through specific algorithms to achieve delicate control of the prosthetic hand. The Dexus Prosthetic System is developed to facilitate daily life and must not be used for unusual activities (e.g. sports that may damage the mechanical wrist, like pushups) and should not be used for the operation of motor vehicles, heavy equipment, industrial machines, or motor-driven equipment.

The Dexus Prosthetic System is not suitable for patients with severe disorders of blood clotting mechanism, patients with mental diseases, patients with unhealed wound on the stump, and other patients who are considered medically unable to fit a prosthetic hand.

The Dexus Prosthetic System is intended exclusively for use on one patient. The Dexus Prosthetics System needs to be installed by trained prosthetists to meet the needs of the end-users.

The Dexus Prosthetic system consists of an electric prosthetic hand and a socket (customized according to the stump of the user and does not come with the subject device), two electrodes, electrode patch cord and electrode screw, charging cord, battery, battery cable and adapter plate, heat-shrinkable sleeve, Power switch assembly, some screws and glove.

The Dexus Prosthetic System has a total of 6 degrees of freedom (DOF), the distribution is as follows:

☐ Thumb (1st finger) DOF: 2 degrees of freedom, which are flexion/extension, adduction/abduction, respectively, a combination of them can make the thumb move freely, and the state can be identified;
☐ Index finger (2nd finger) DOF: 1 degree of freedom, flexion/extension movement;
☐ Middle finger (3rd finger) DOF: 1 degree of freedom, flexion/extension movement;
☐ Ring finger (the 4th finger) DOF: 1 degree of freedom, flexion/extension movement;
☐ Little finger (5th finger) DOF: 1 degree of freedom, flexion/extension movement.

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In addition, its gesture functions include Prehensile Grasp, Tipping, Tripod Pinch, Index pointing, Lateral Pinch, and Hook. The functions can be switched through the buttons on the back of the hand.

# 5. Intended Use / Indications for Use

The Dexus Prosthetic System is to be used exclusively for external prosthetic fittings of the upper limbs.

# 6. Test Summary

# 6.1 Summary of Non-Clinical Tests

Dexus Prosthetics System has been evaluated the safety and performance by lab bench testing as following:

Electrical safety test according to IEC 60601-1, IEC 60601-1-6 and IEC 60601-1-11 standards
Electromagnetic compatibility test according to IEC 60601-1-2 standard
Safety test of lithium battery according to IEC 62133-2 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 the Content of Premarket Submissions for Software Contained in Medical Devices"

# 6.2 Summary of Clinical Performance Test

No clinical study is included in this submission.

# 7. Comparison to predicate device and conclusion

Compared with the predicate devices (Manufacturer's Legally marketed device), the subject device is the same in technical design, intended use/indications for use, functions, etc. And the differences between the subject device and predicate devices do not raise new questions of safety or effectiveness. Please refer to the detailed Substantial Equivalence Comparison of the subject device and predicate devices in the following table.

Comparison in Detail(s):

|  Elements of Comparison | Subject Device | Predicate Device (Manufacturer's Legally marketed device) | Verdict  |
| --- | --- | --- | --- |
|  Manufacturer | Zhejiang Qiangnao Technology Co.,Ltd | Zhejiang Qiangnao Technology Co.,Ltd | --  |
|  Trade Name | Dexus Prosthetic System | Dexus Prosthetic System | --  |
|  Models | MSL2, MSR2 | MSL1, MSR1 | --  |
|  510(k) Number | Pending | K220002 | --  |
|  Classification Name | Cutaneous electrode | Cutaneous electrode | Same  |

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|  Classification Product Code | GXY | GXY | Same  |
| --- | --- | --- | --- |

|  Elements of Comparison | Subject Device | Predicate Device (Manufacturer's Legally marketed device) | Verdict  |
| --- | --- | --- | --- |
|  Subsequent Product Code | IQZ | IQZ | Same  |
|  Intended Use / Indications for Use | The Dexus Prosthetic System is to be used exclusively for external prosthetic fittings of the upper limbs. | The Dexus Prosthetic System is to be used exclusively for external prosthetic fittings of the upper limbs. | Same  |
|  Principle of operation | Detect, process, and transmit physiological signals for use with a prosthesis and controls the terminal device. | Detect, process, and transmit physiological signals for use with a prosthesis and controls the terminal device. | Same  |
|  System Components | Dexus Hand (terminal device) Dexus Wrist (passive rotation) Dexus Power (battery) Dexus Charge (charger) Dexus Center (control unit) Dexus Electrode (detect EMG signals) Dexus Skin (prosthetic glove) | Dexus Hand (terminal device) Dexus Wrist (passive rotation) Dexus Power (battery) Dexus Charge (charger) Dexus Center (control unit) Dexus Electrode (detect EMG signals) Dexus Skin (prosthetic glove) | Same  |
|  Environment of Use | Professional healthcare facility and home use | Professional healthcare facility and home use | Same  |
|  Assembling procedure | Components are assembled by a prosthetist | Components are assembled by a prosthetist | Same  |
|  Technological Characteristics - System  |   |   |   |
|  Signal acquisition | EMG electrode | EMG electrode | Same  |
|  Power Source | Rechargeable battery | Rechargeable battery | Same  |

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|  Adjustment software | No | No | Same  |
| --- | --- | --- | --- |
|  Software/Firmware/Microprocessor Control? | Yes | Yes | Same  |
|  Terminal device (e.g., Hand, wrist or elbow) included? | Yes | Yes | Same  |

|  Elements of Comparison | Subject Device | Predicate Device (Manufacturer's Legally marketed device) | Verdict  |
| --- | --- | --- | --- |
|  Wireless Communication | No | No | Same  |
|  Technological Characteristics - Hand  |   |   |   |
|  Operating temperature | +5°C to +40°C | +5°C to +40°C | Same  |
|  Weight | 530g | 530g | Same  |
|  Max. Gripping force | 12N (all mode) | 12N (all mode) | Same  |
|  Max. Grip Speed | 150mm/s | 150mm/s | Same  |
|  Max. Opening Width | 106mm | 106mm | Same  |
|  Technological Characteristics - Electrode  |   |   |   |
|  Dimensions | 34.5mm x 16mm x 11.5mm | 34.5mm x 16mm x 11.5mm | Same  |
|  Operating temperature | 0°C - 40°C | 0°C - 40°C | Same  |
|  Material | Polycarbonate: PC2858, Thermoplastic Elastomer: TM5ADT and Metal Pieces: C1SQIN | Polycarbonate: PC2858, Thermoplastic Elastomer: TM5ADT and Metal Pieces: C1SQIN | Same  |
|  Contact area | Copper plated | Copper plated | Same  |
|  Frequency bandwidth | 80 - 500 Hz | 80 - 500 Hz | Same  |
|  Adjustment | None | None | Same  |
|  Installation | Suction socket | Suction socket | Same  |
|  Technological Characteristics - Battery  |   |   |   |
|  Chemistry | Li Ion | Li Ion | Same  |
|  Number of cells | 2 | 2 | Same  |

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|  Nominal voltage | 7.2V | 7.4V | Similar Note 1  |
| --- | --- | --- | --- |
|  Battery capacity | 3000mAh | 2200mAh | Similar Note 1  |
|  Charging time | Max.4.0h | Max.3.0h | Similar Note 1  |
|  Battery weight | 110g | 110g | Same  |
|  Battery dimensions (L*W*H) (mm) | 68x38x20 | 68x38x20 | Same  |
|  Installation | Integrated | Integrated | Same  |
|  Safety and Performance Testing  |   |   |   |
|  Electrical Safety | IEC 60601-1 IEC 60601-1-11 | IEC 60601-1 IEC 60601-1-11 | Same  |
|  **Elements of Comparison** | **Subject Device** | **Predicate Device** (Manufacturer's Legally marketed device) | **Verdict**  |
|  Electromagnetic Compatibility | IEC 60601-1-2 | IEC 60601-1-2 | Same  |
|  Biocompatibility | ISO 10993-1 ISO 10993-5 ISO 10993-10 | ISO 10993-1 ISO 10993-5 ISO 10993-10 | Same  |

# **Note 1:**

Although the "Nominal voltage", "Battery capacity" and "Charging time" of the subject device are different from the predicate device, all of them meet the requirements of safety and performance standards IEC 60601-1, IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2 and IEC 62133-2. So, the differences between the predicate device and the subject device will not affect the safety and effectiveness of the subject device.

# **8. Final Conclusion:**

The subject device Dexus Prosthetics System has all features of the predicate device (Manufacturer's Legally marketed device, K220002). The few differences do not affect the safety and effectiveness of the subject device. Thus, the subject device is substantially equivalent to the predicate device.

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**Source:** [https://fda-staging.innolitics.com/device/K262654](https://fda-staging.innolitics.com/device/K262654)

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