Apollo Quattro (APQ-10M)
Device Facts
| Record ID | K253542 |
|---|---|
| Device Name | Apollo Quattro (APQ-10M) |
| Applicant | Weero Co., Ltd. |
| Product Code | IPF · Physical Medicine |
| Decision Date | Jun 8, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5850 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
Q-LF handpiece, Q-FX handpiece, Q-SC handpiece, and Q-BT handpiece in EMS mode are intended for: - Relaxation of muscle spasms - Prevention or retardation of disuse atrophy - Increasing local blood circulation - Muscle re-education - Maintaining or increasing range of motion - Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis Q-EP handpiece in TENS mode is intended for: - Symptomatic relief and management of chronic, intractable pain - Post-surgical acute pain - Post-trauma acute pain
Device Story
Apollo Quattro is a combination stimulator delivering EMS and TENS therapy. System comprises a main console with 10.1-inch LCD touchscreen and five handpieces (Q-LF, Q-FX, Q-SC, Q-BT for EMS; Q-EP for TENS). Device operates via AC/DC power supply; controlled by user interface. EMS mode uses symmetrical biphasic rectangular waveforms; TENS mode uses symmetrical biphasic or pulsed monophasic rectangular waveforms. Clinician operates device in clinical setting. Output parameters (frequency, pulse width, intensity) are adjustable via touchscreen. Output affects muscle contraction (EMS) or nerve stimulation (TENS) to manage pain or muscle conditions. Device includes safety features like automatic overload/no-load trips and shut-off. Integrated modes (RF, cooling, heating) are excluded from this review.
Clinical Evidence
Bench testing only. Performance evaluated against IEC 60601-1 (safety), IEC 60601-1-2 (EMC), and IEC 60601-2-10 (nerve/muscle stimulators). Biocompatibility of patient-contacting materials (Stainless Steel 304, Polycarbonate) established via reference to previously cleared device (K212253) per ISO 10993-1. Software validated per IEC 62304.
Technological Characteristics
Powered muscle stimulator/TENS. Materials: Stainless Steel 304 (electrodes), Polycarbonate (display). Energy: Electrical (100-240VAC). Output: Symmetrical biphasic/pulsed monophasic waveforms. Connectivity: Standalone console with touchscreen. Safety: Type BF, transformer isolation, automatic overload/no-load trip. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 14971, ISO 10993-1.
Indications for Use
Indicated for patients requiring muscle stimulation for spasm relaxation, atrophy prevention, blood circulation, muscle re-education, range of motion maintenance, or post-surgical calf stimulation; and for patients requiring TENS for chronic intractable pain, post-surgical acute pain, or post-trauma acute pain.
Regulatory Classification
Identification
A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.
Predicate Devices
Reference Devices
- Apollo Duet (K212253)
Submission Summary (Full Text)
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**FDA** **U.S. FOOD & DRUG**
ADMINISTRATION
June 8, 2026
Weero Co., Ltd.
Han Moon Young
Regulatory Affairs
A-205, Venture Valley Ii, 142-10, Saneop-Ro 156 Beon-Gil
Gwonseon-Gu Suwon-Si, Gyeonggi-Do
Suwon, Gyeonggi 16648
Republic Of Korea
Re: K253542
Trade/Device Name: Apollo Quattro (APQ-10M)
Regulation Number: 21 CFR 890.5850
Regulation Name: Powered Muscle Stimulator
Regulatory Class: Class II
Product Code: IPF, GZJ
Dated: November 14, 2025
Received: May 6, 2026
Dear Han Moon Young:
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'
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20903
www.fda.gov
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K253542 - Han Moon Young
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(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-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).
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K253542 - Han Moon Young
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Sincerely,
JITENDRA V. VIRANI -S
CDR Jitendra Virani, MS, MBA
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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
# Indications for Use
510(k) Number (if known)
K253542
Device Name
Apollo Quattro (APQ-10M)
Indications for Use (Describe)
Q-LF handpiece, Q-FX handpiece, Q-SC handpiece, and Q-BT handpiece in EMS mode are intended for:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Maintaining or increasing range of motion
- Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
Q-EP handpiece in TENS mode is intended for:
- Symptomatic relief and management of chronic, intractable pain
- Post-surgical acute pain
- Post-trauma acute pain
Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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Apollo Quattro
510(k) Summary_K253542
**1. Submitter and US Official Correspondent**
Submitter : WEERO Co.,Ltd.
Address: A205 VentureValley II, 142-10, Saneop-ro 156beon-gil, Gwonseon-gu, Suwon-si, Gyeonggi-do, Republic of Korea
Telephone No.: +82-31-427-0787
Official Correspondent: Moon-young Han
Correspondent: WEERO Co.,Ltd.
Address: A205 VentureValley II, 142-10, Saneop-ro 156beon-gil, Gwonseon-gu, Suwon-si, Gyeonggi-do, Republic of Korea
Telephone No.: +82-31-427-0787
Email: ra@weeroweero.com
Data Prepared: May 22, 2026
**2. Device Information**
Trade/Device Name: Apollo Quattro / APQ-10M
Regulation Name: - Powered Muscle Stimulator
- Transcutaneous electrical nerve stimulator for pain relief
Product Code: IPF, GZJ
Regulatory Class: Class II
Regulation Number: 21CFR890.5850, 21CFR882.5890
**3. Predicate Devices(Equivalent Legally Marketed Device)**
| Manufacturer | Device | 510(k) No. |
| --- | --- | --- |
| **Primary Predicate Device** | | |
| WEERO Co.,Ltd. | EVE Synergy | K241433 |
| **Secondary Predicate** | | |
| InMode Ltd. | EVOLVE System with the T3 Applicator | K210877 |
**4. Description of the Device**
Apollo Quattro is a combination stimulator to deliver electrical muscle stimulation (EMS) and transcutaneous electrical nerve stimulation (TENS). The device consists of a main console unit with a 10.1-inch LCD touchscreen interface and five handpieces: Q-LF, Q-FX, Q-SC, Q-BT, and Q-EP handpieces. The Q-LF, Q-FX, Q-SC, and Q-BT handpieces deliver electrical muscle stimulation (EMS) therapy. The Q-EP handpiece delivers transcutaneous electrical nerve stimulation (TENS) therapy using a monopolar electrode configuration with a return patch (cleared under K042301) to complete the current circuit. Additional components include patch cable, funnel hose, and power cable.
This device also includes other therapeutic components and modes that are not within the scope of this 510(k) review. The radio frequency and cooling modes were previously cleared under K253261. The device includes a Class I exempt powered heating pad component that operates as a standalone mode and is not within scope of this 510(k) review. Since all these modes are integrated into the same device and share common labeling, they are referenced here for completeness.
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Apollo Quattro
510(k) Summary_K253542
**5. Indications for use (intended use)**
Q-LF handpiece, Q-FX handpiece, Q-SC handpiece, and Q-BT handpiece in EMS mode are intended for:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Maintaining or increasing range of motion
- Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
Q-EP handpiece in TENS mode is intended for:
- Symptomatic relief and management of chronic, intractable pain
- Post-surgical acute pain
- Post-trauma acute pain
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Apollo Quattro
510(k) Summary\_K253542
## 6. Substantial Equivalence Discussion
Note: The Apollo Quattro device includes a Class I exempt powered heating pad component (21 CFR 890.5740, Product Code IRT) that operates as a standalone therapeutic mode. As this component is Class I exempt, substantial equivalence does not need to be established with a predicate device for the heating pad functionality, and therefore it is not part of this 510(k) review. Moreover, the device also includes radio frequency and cooling modes where were previously cleared under K253261 and not within the scope of subject submission. While this device includes EMS, TENS, powered heating, radio frequency, and cooling modalities, safety and effectiveness have not been evaluated of combined use of two or more of these modalities or sequential use of any of these modalities. Since these modalities are intended to be used as a standalone and none of them are intended to be used in combination or sequentially, the scope of this submission review is on individual use of EMS and TENS modalities only. Therefore, the substantial equivalence discussion below focuses solely on the EMS and TENS functionalities as a standalone use.
### 1) Comparison Information
| Name | Subject Device | Primary Predicate Device | Secondary Predicate Device | Comparison |
| --- | --- | --- | --- | --- |
| Device Name | Apollo Quattro(APQ-10M) | EVE Synergy(EVE-20M) | EVOLVE System with the T3 Applicator | |
| Manufacturer | WEERO Co.,Ltd. | WEERO Co.,Ltd. | InMode Ltd. | |
| 510(k) No. | - | K241433 | K210877 | |
| Product Code, Class | IPF, GZJ Class II | IPF, GZJ Class II | IPF, GZJ Class II | Identical |
| Indications for use | EMS is used for: • Relaxation of muscle spasms • Prevention or retardation of disuse atrophy • Increasing local blood circulation • Muscle re-education • Maintaining or increasing range of motion • Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis TENS is used for: • Symptomatic relief and management of chronic, intractable pain • Post-surgical acute pain • Post-trauma acute pain | EMS is used for: • Relaxation of muscle spasms • Prevention or retardation of disuse atrophy • Increasing local blood circulation • Muscle re-education • Maintaining or increasing range of motion • Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis TENS is used for: • Symptomatic relief and management of chronic, intractable pain • Post-surgical acute pain • Post-trauma acute pain | EMS mode is intended for: • Relaxation of muscle spasms • Prevention or retardation of disuse atrophy • Increasing local blood circulation • Muscle re-education • Maintaining or increasing range of motion • Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis TENS mode is intended for: • Symptomatic relief and management of chronic, intractable pain • Post-surgical acute pain • Post-trauma acute pain | Identical |
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Apollo Quattro
510(k) Summary\_K253542
| Name | Subject Device | Primary Predicate Device | Secondary Predicate Device | Comparison |
| --- | --- | --- | --- | --- |
| Device Name | Apollo Quattro(APQ-10M) | EVE Synergy(EVE-20M) | EVOLVE System with the T3 Applicator | |
| Manufacturer | WEERO Co.,Ltd. | WEERO Co.,Ltd. | InMode Ltd. | |
| 510(k) No. | - | K241433 | K210877 | |
| Design | The Apollo Quattro consists of an AC/DC power supply unit, controller, and user interface including an LCD touch screen. The delivery of the electrical energy is controlled by a Start/Stop button positioned on the front panel. The System supports the following components: • LCD display touch screen • Audio loudspeaker • 24V AC/DC power supply • Controller | The EVE Synergy consists of an AC/DC power supply unit, controller, and user interface including an LCD touch screen. The delivery of the electrical energy is controlled by a Start/Stop button positioned on the front panel. The System supports the following components: • LCD display touch screen • Audio loudspeaker • 24V AC/DC power supply • Controller | The EVOLVE System with T3 Applicator consists of an AC/DC power supply unit, Controller and user interface including an LCD touch screen. The delivery of the RF/electrical energy is controlled by a Start/Stop button positioned on the front panel. The System supports the following components: • LCD display touch Screen • Audio loudspeaker • 48V AC/DC power Supply • Controller | Identical |
| - Components Console | The Apollo Quattro consists of the following components: • Power supply unit, Console, including controller and user interface including an LCD touch screen. • The system includes 5 handpiece types, with up to 2 handpieces connected simultaneously to the console via 2 designated cables and 2 designated connection ports | The EVE Synergy consists of the following components: • Power supply unit, Console, including controller and user interface including an LCD touch screen. • Handpieces with up to 3 units connected to the console via 3 designated cables and 3 designated connection ports. | The EVOLVE System consists of the following components: • Console, including a power supply unit, controller and user interface including an LCD touch screen. • T3 Applicator with up to 6 units connected to the console via 6 designated cables and 6 designated connection ports. | Not identical. Although the number of connection ports is different from the predicate device, both the subject and predicate devices comply with IEC 60601-1 and IEC 60601-2-10 requirements and the difference doesn't impact essential performance, basic safety or substantial equivalence. |
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Apollo Quattro
510(k) Summary_K253542
| Name | Subject Device | Primary Predicate Device | Secondary Predicate Device | Comparison |
| --- | --- | --- | --- | --- |
| Device Name | Apollo Quattro(APQ-10M) | EVE Synergy(EVE-20M) | EVOLVE System with the T3 Applicator | |
| Manufacturer | WEERO Co.,Ltd. | WEERO Co.,Ltd. | InMode Ltd. | |
| 510(k) No. | - | K241433 | K210877 | |
| Dimension | Main unit: 40.5cm(W) x 39.1cm(D) x 104.1cm(H) [15.9"(W) x 15.4"(D) x 41"(H)] Q-LF handpiece: 37.3mm(W) x 172.8mm(D) x 37.6mm(H) [1.5"(W) x 6.8"(D) x 1.5"(H)] Q-FX handpiece: 28.8mm(W) x 147.1mm(D) x 28.8mm(H) [1.1"(W) x 5.8"(D) x 1.1"(H)] Q-SC handpiece: 71.5mm(W) x 172.5mm(D) x 53.1mm(H) [2.8"(W) x 6.8"(D) x 2.1"(H)] Q-BT handpiece: 70.8mm(W) x 168.4mm(D) x 70.8mm(H) [2.8"(W) x 6.6"(D) x 2.8"(H)] Q-EP handpiece: 37.3mm(W) x 167.6mm(D) x 37.3mm(H) [1.5"(W) x 6.6"(D) x 1.5"(H)] | Main unit: 22.4cm W x 41.8cm D x 32.5cm H [8.8" W x 16.5" D x 12.8" H] Synergy handpiece: 167.5mm L x 43 mm D [6.6" L x 1.7" D] Pro handpiece: 136mm L x 27.5mm D [5.4" L x 1.1" D] Ball type tip: 86mm L x 18mm D [3.4" L x 0.7" D] T type tip: 80mm L x 50mm D [3.1" L x 2.0" D] COMB type tip: 88mm L x 30mm D [3.5" L x 1.2" D] | Main unit: 46cm W x 46cm D x 100cm H [18.2" W x 18.2" D x 44" H] T3 Applicator unit: 67.3mm L x 54.3mm D [2.7" L x 2.2" D] | Not identical. Although the dimension and weight of the subject device is different from the predicate device, both the subject and predicate devices comply with IEC 60601-1 and IEC 60601-2-10 requirements, which ensures that they meet the necessary safety and performance standards. The difference in dimension and weight does not affect essential performance, basic safety, or substantial equivalence. |
| Weight | Main unit: 20 kg / 44.1 lb Q-LF handpiece: 78.5 g [0.2 lb] Q-FX handpiece: 48.5 g [0.1 lb] Q-SC handpiece: 181.5 g [0.4 lb] Q-BT handpiece: 138 g [0.3 lb] Q-EP handpiece: 220 g [0.5 lb] | Main unit: 7 kg [15.4 lbs.] Synergy handpiece: 0.12 kg [0.26 lbs.] Pro handpiece: 0.06 kg [0.13 lbs.] Ball type tip: 0.04 kg [0.08 lbs.] T type tip: 0.02 kg [0.04 lbs.] COMB type tip: 0.02 kg [0.04 lbs.] | Main unit: 33.0 Kg [73 lbs.] T3: 0.16 Kg [0.4 lbs.] | |
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Apollo Quattro
510(k) Summary_K253542
| Name | Subject Device | Primary Predicate Device | Secondary Predicate Device | Comparison |
| --- | --- | --- | --- | --- |
| Device Name | Apollo Quattro(APQ-10M) | EVE Synergy(EVE-20M) | EVOLVE System with the T3 Applicator | |
| Manufacturer | WEERO Co.,Ltd. | WEERO Co.,Ltd. | InMode Ltd. | |
| 510(k) No. | - | K241433 | K210877 | |
| Applicator unit treatment area | Electrode area of the Q-LF handpiece(4ea) : 6.78 cm² Electrode area of the Q-FX handpiece(2ea) : 3.9 cm² Electrode area of the Q-SC handpiece(2ea) : 51.6 cm² Electrode area of the Q-BT handpiece(6ea) : 27.57 cm² Electrode area of the Q-EP handpiece(1ea) : 10.37 cm² | Synergy handpiece electrode(2ea): 6 cm² Ball type tip: 10.17 cm² T type tip: 7.85 cm² COMB type tip: 28.83 cm² | 6.46 cm² | Not identical. However, the difference doesn't raise new questions of safety and effectiveness. |
| Power Source(s) | Main Line Frequency (nominal) 50-60Hz Input Voltage (nominal) 100-240VAC Input Current (rms) 4A | Power Supply Adapter - Input: 100-240Vac, 50/60Hz, 1.4-0.7A - Output: 24Vdc, 5A | Main Line Frequency (nominal) 50-60Hz Input Voltage (nominal) 100-240VAC Input Current (rms) 4A | Identical |
| Method of Line Current Isolation | Independent transformer isolated | Independent transformer isolated | Independent transformer isolated | Identical |
| Electrical Type | Type BF | Type BF | Type BF | Identical |
| Patient Leakage Current – Normal Condition (μA) | <100uA patient leakage | <100uA patient leakage | <100uA patient leakage | Identical |
| Patient Leakage Current – Single Fault Condition (μA) | <300uA line leakage | <300uA line leakage | <300uA line leakage | Identical |
| Number of Output Modes | 5 | 2 | Unknown | Not identical. However, the difference doesn't raise new questions of safety and effectiveness. |
| Number of Output Channels | 2 | 3 | 6 | |
| Synchronous or Alternating | See Output Specifications Below | See Output Specifications Below | See Output Specifications Below | Identical |
| Method of Channel Isolation | Through transformers and isolators | Through transformers and isolators | Through transformers and isolators | Identical |
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Apollo Quattro
510(k) Summary_K253542
| Name | Subject Device | Primary Predicate Device | Secondary Predicate Device | Comparison |
| --- | --- | --- | --- | --- |
| Device Name | Apollo Quattro(APQ-10M) | EVE Synergy(EVE-20M) | EVOLVE System with the T3 Applicator | |
| Manufacturer | WEERO Co.,Ltd. | WEERO Co.,Ltd. | InMode Ltd. | |
| 510(k) No. | - | K241433 | K210877 | |
| Regulated Current or Regulated Voltage (output signal only) | Regulated voltage on all channels With current limit | Regulated voltage on all channels With current limit | Regulated voltage on all channels With current limit | Identical |
| Software/Firmware/Microprocessor Control | Yes | Yes | Yes | Identical |
| Automatic Overload Trip | Yes | Yes | Yes | Identical |
| Automatic No-Load Trip | Yes | Yes | Yes | Identical |
| Automatic Shut Off | Yes | Yes | Yes | Identical |
| Patient Override Control | No | No | Yes | Identical |
| - On/Off Status | Yes | Yes | Yes | Identical |
| - Battery | No battery | No battery | No battery | Identical |
| -Voltage/Current level | Yes | Yes | Yes | Identical |
| Timer Range | 0-60 [minutes] | 0-60 [minutes] | 0-60 [minutes] | Identical |
| Compliance with 21 CFR 890.5850 (IPF) | Yes | Yes | Yes | Identical |
| Compliance with 21 CFR 882.5890 (GZJ) | Yes | Yes | Yes | Identical |
| **EMS Output** | | | | |
| Output Specifications: Waveform | Symmetrical Biphasic Waveform | Symmetrical Biphasic Waveform | Symmetrical Biphasic Waveform | Identical |
| Pulse Shape | Rectangular | Rectangular | Rectangular | Identical |
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Apollo Quattro
510(k) Summary_K253542
| Name | Subject Device | Primary Predicate Device | Secondary Predicate Device | Comparison |
| --- | --- | --- | --- | --- |
| Device Name | Apollo Quattro(APQ-10M) | EVE Synergy(EVE-20M) | EVOLVE System with the T3 Applicator | |
| Manufacturer | WEERO Co.,Ltd. | WEERO Co.,Ltd. | InMode Ltd. | |
| 510(k) No. | - | K241433 | K210877 | |
| Maximum Output Voltage (± 20%) | 34 V @500Ω 48 V @2kΩ 48 V @10kΩ | 34 V @500Ω 48 V @2kΩ 48 V @10kΩ | 30 V @500Ω 54 V @2kΩ 54 V @10kΩ | Identical |
| Maximum Output Current (± 20%) | 68 mA @500Ω 24 mA @2kΩ 4.8 mA @10kΩ | 68 mA @500Ω 24 mA @2kΩ 4.8 mA @10kΩ | 60 mA @500Ω 27 mA@2kΩ 5.4 mA @10kΩ | |
| Pulse Width(μsec.) – The output active positive pulse width | 100 to 155 [μs] | 100 to 155 [μs] | 20 to 400 [μs] | Identical |
| Frequency (Hz) | 3 to 200 [Hz] | 3 to 200 [Hz] | 3 to 200 [Hz] | Identical |
| Net Charge @ 500 Ohms [μC/pulse] | 0 [μC] @ 500Ω | 0 [μC] @ 500Ω | 0 [μC] @ 500Ω | Identical |
| Maximum Phase Charge [μC] | 10.54 [μC] @500Ω | 10.54 [μC] @500Ω | 24 [μC] @500Ω | Identical |
| Maximum Current (RMS) Density [mA/cm²] | 1.28 [mA/cm²] Surface = 3.9 cm² | 1.31 [mA/cm²] Surface = 6 cm² | 0.74 [mA/cm²] Surface = 6.46cm² | Not identical. The maximum current density and maximum power density of the subject device are similar to the predicate devices(K241433); therefore, they do not raise new questions about safety and effectiveness. |
| Maximum Power Density [mW/cm²] | 43.6 [mW/cm²] @ 500Ω | 47 [mW/cm²] @ 500Ω | 22.2 [mW/cm²] @ 500Ω | |
| Burst Mode (i.e.,pulse trains) a. Pulses per burst b. Bursts per second c. Burst duration (seconds) d. Duty Cycle [Line (b) x Line(c)] | Yes: a. 3 – 200 b. 1 c. 1-60 sec d. Time on / off | Yes: a. 3 – 200 b. 1 c. 1-60 sec d. Time on / off | Yes: a. 3 – 200 b. 1 c. 1-60 sec d. Time on / off | Identical |
| On time (sec.) | 1 – 60 [sec] | 1 – 60 [sec] | 1 – 60 [sec] | Identical |
| Off time (sec.) | 1 – 60 [sec] | 1 – 60 [sec] | 1 – 60 [sec] | Identical |
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Apollo Quattro
510(k) Summary_K253542
| Name | Subject Device | Primary Predicate Device | Secondary Predicate Device | Comparison |
| --- | --- | --- | --- | --- |
| Device Name | Apollo Quattro(APQ-10M) | EVE Synergy(EVE-20M) | EVOLVE System with the T3 Applicator | |
| Manufacturer | WEERO Co.,Ltd. | WEERO Co.,Ltd. | InMode Ltd. | |
| 510(k) No. | - | K241433 | K210877 | |
| Treatment Time (min) - the time limit that will put the system in STOP state Level | Up to 60 min | Up to 60 min | Up to 60 min | Identical |
| **TENS Output** | | | | |
| Output Specifications: Waveform | Symmetrical Biphasic Waveform, Pulsed Monophasic | Symmetrical Biphasic Waveform, Pulsed Monophasic | Symmetrical Biphasic Waveform | Identical |
| Pulse Shape | Rectangular | Rectangular | Rectangular | Identical |
| Maximum Output Voltage((± 20%) | 20 V @500Ω 28 V @2kΩ 28 V @10kΩ | 10 V @500Ω 10 V @2kΩ 10 V @10kΩ | 19 V @500Ω 19 V @2kΩ 19 V @10kΩ | Not identical. The maximum output voltage and current of the subject device are similar to those of the secondary predicate device. In addition, since the maximum power density of both devices is identical, the total energy delivered to the tissue remains identical in its effect on tissue response. Therefore, these differences do not raise new questions about safety and effectiveness. |
| Maximum Output Current((± 20%) | 40 mA @500Ω 14 mA @2kΩ 2.8 mA @10kΩ | 20 mA @500Ω 5.0 mA @2kΩ 1.0 mA @10kΩ | 38 mA @500Ω 9.5 mA @2kΩ 1.9 mA @10kΩ | |
| Pulse Width(μsec.) – The output active positive pulse width | 100 [μs] | 100 to 150 [μs] | 20 to 400 [μs] | Not identical. Since the pulse width and frequency of the subject device are within the range of the predicate devices, it does not raise new questions about safety and effectiveness. |
| Frequency(Hz) | 50 Hz | 3 to 200 [Hz] | 3 to 200 [Hz] | |
| Net Charge @ 500 Ohms [μC/pulse] | 0 [μC] @500Ω | 0 [μC] @500Ω | 0 [μC] @ 500Ω | Identical |
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Apollo Quattro
510(k) Summary_K253542
| Name | Subject Device | Primary Predicate Device | Secondary Predicate Device | Comparison |
| --- | --- | --- | --- | --- |
| Device Name | Apollo Quattro(APQ-10M) | EVE Synergy(EVE-20M) | EVOLVE System with the T3 Applicator | |
| Manufacturer | WEERO Co.,Ltd. | WEERO Co.,Ltd. | InMode Ltd. | |
| 510(k) No. | - | K241433 | K210877 | |
| Maximum Phase Charge [μC] | 4.0 [μC] @500Ω | 3.0 [μC] @500Ω | 15.2 [μC] @ 500Ω | Not identical. Maximum Phase Charge is related to the maximum output current and pulse width, and because the predicate device has various pulse widths, the range of phase charge depends on the pulse width range. For example, for the secondary predicate device, the phase charge ranges from 0.76 μC to 15.2 μC. Because the phase charge of the subject device is within the range of the predicate device, it does not raise new questions about safety and effectiveness. |
| Maximum Current Density [mA/cm²] | 0.47 [mA/cm²] Surface = 10.37 cm² | 0.83 [mA/cm²] Surface = 6 cm² | 0.47 [mA/cm²] Surface = 6.46 cm² | Identical |
| Maximum Power Density [mW/cm²] | 8.9 [mW/cm²] @ 500Ω | 8.3 [mW/cm²] @ 500Ω | 8.9 [mW/cm²] @ 500Ω | Identical |
| Burst Mode (i.e., pulse trains) a. Pulses per burst b. Bursts per second c. Burst duration (seconds) d. Duty Cycle[Line (b) x Line(c)] | Yes: a. 3 – 200 b. 1 c. 1-60 sec d. Time on / off | Yes: a. 3 – 200 b. 1 c. 1-60 sec d. Time on / off | Yes: a. 3 – 200 b. 1 c. 1-60 sec d. Time on / off | Identical |
| On time (sec.) | 1 – 60 [sec] | 1 – 60 [sec] | 1 – 60 [sec] | Identical |
| Off time (sec.) | 1 – 60 [sec] | 1 – 60 [sec] | 1 – 60 [sec] | Identical |
| Treatment Time (min) - the time limit that will put the system in STOP state Level | Up to 60 min | Up to 60 min | Up to 60 min | Identical |
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---Apollo Quattro
510(k) Summary\_K253542---
## 2) Substantial Equivalence Discussion
There are differences on a few things. However, these differences do not affect the significant equivalence of the device and its predicates.
The subject device and predicate devices utilize the same technology, for the same indication for use, and with almost identical design specifications. The device emits EMS or TENS electrical signals with similar power and current densities, pulse characteristics, and bear almost identical system components to its predicate devices such as; user interface, and hardware components. All of the subject device performance specifications are equal or similar to those of its predicate devices. The differences in technical specifications should not alter the device safety and effectiveness.
Furthermore, the subject device had underwent the required performance testing and validation testing and demonstrates its conformance with device design requirements and with applicable standards.
The safety features and compliance with safety standards of the subject device are similar to the safety features and compliance with safety standards of the predicate devices. All user-contacting materials were tested for biocompatibility and found to comply with the ISO 10993-1 standard.
The electrodes and LED display part used in subject device are the same raw material as the electrodes and LED display part used in Apollo Duet, which cleared 510(k) 'K212253' from WEERO Co.,Ltd..
The electrodes and LED display part used in Apollo Duet passed the biocompatibility test in compliance with ISO 10993-1 and are the same as the raw materials used in the subject device.
The electrode(Stainless Steel 304) and LED display part(Polycarbonate) of the Apollo Quattro(APQ-10M) in its final finished form are identical to the electrode(Stainless Steel 304) and LED display part(Polycarbonate) of the Apollo Duet (K212253) in formulation, processing, sterilization, and geometry, and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents).
Furthermore, the design and development phases of the subject device were validated throughout a set of performance tests, including software validation testing, electrical and mechanical safety testing according to IEC 60601-1 standard, electromagnetic compatibility testing according to IEC 60601-1-2 standard, and safety and essential performance of nerve and muscle stimulators testing according to IEC 60601-2-10 standard. These performance tests demonstrated that the device specifications meet the system requirements and do not raise new safety or effectiveness concerns.
## 3) Conclusion
'EVE Synergy(EVE-20M)' and 'EVOLVE System with the T3 Applicator' were chosen as predicate devices for the subject device in consideration of the intended use, indications, performance and principles of operation. Differences between the subject and the predicate devices were found and listed within the above comparison table and discussion. Considerable amount of testing, including electrical safety, electromagnetic compatibility, performance, software verification and validation and usability testing were performed to support the claims of appropriately chosen predicate device. The test results show that the specifications and performance of Apollo Quattro(APQ-10M) are as safe and effective as legally marketed predicate devices.
Therefore, it is concluded that the Apollo Quattro(APQ-10M) is substantially equivalent to the legally marketed predicate devices.
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Apollo Quattro
510(k) Summary_K253542
# 7. Non-Clinical (Bench) Performance Data:
As part of demonstrating safety and effectiveness of the Apollo Quattro and in showing substantial equivalence to the predicate device that are subject to this 510(k) submission, we completed a number of non-clinical performance tests against applicable standards.
- Basic safety and essential performance of the Apollo Quattro was tested and evaluated according to the IEC 60601-1:2005/A2:2020.
- Effect to the device by electromagnetic disturbances was tested and evaluated according to the FDA-recognized consensus standard IEC 60601-1-2:2014/A1:2020.
- Particular requirements for the basic safety and essential performance of nerve and muscle stimulators was tested and evaluated according to the IEC 60601-2-10:2012/A2:2023.
- Risk management was recorded by referring to ISO 14971:2019.
- For biocompatibility, all user-contacting materials (i.e., Stainless Steel 304 and Polycarbonate) are the same as those previously cleared under K212253.
- Software was tested and evaluated according to IEC 62304:2015
- Content of Premarket Submissions for Device Software Functions
The Apollo Quattro passed all the testing in accordance with internal requirements, national standards, and international standards shown above, to support substantial equivalence of the subject device.
Also, to demonstrate that the Apollo Quattro meets all design specifications and performance requirements, and to measure the accuracy of the output parameters of Apollo Quattro and to compare the output parameters with predicate devices, nonclinical bench testing was performed in accordance with the internal process in compliance with the recommendations of the FDA Guidance Document for Powered Muscle Stimulator 510(k)s.
The testing results support that the requirements for performance and electrical safety were met for the acceptance of the device. The Apollo Quattro passed all testing and supports the claims of substantial equivalence to the predicate device.
# 8. Sterilization/Disinfection/Cleaning/Shelf Life
The Apollo Quattro is intended for multiple use and therefore must be cleaned according to the instructions provided in the device Instructions for Use. There are no sterilized parts or accessories involved with this device.
# 9. Biocompatibility
| Part | Material | Patient Contact | Duration of Contact by ISO 10993-1 | Bio-compatibility |
| --- | --- | --- | --- | --- |
| Electrodes of handpiece | SUS 304 | Intact Skin | Limited (< 24 hours) | Yes |
| LED Display part | PC(SR3108FM) | | | |
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Apollo Quattro
510(k) Summary\_K253542---
# **10. Conclusion**
Based on the comparison with the predicate devices and on the non-clinical performance testing results demonstrating that the Apollo Quattro is as safe and effective as the predicate devices, it can be concluded that the Apollo Quattro is substantially equivalent to the legally marketed predicate devices.
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