Physiq

K202079 · El.En Electronic Engineering Spa · IPF · Nov 25, 2020 · Physical Medicine

Device Facts

• Record ID: K202079
• Device Name: Physiq
• Applicant: El.En Electronic Engineering Spa
• Product Code: IPF · Physical Medicine
• Decision Date: Nov 25, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PHYSIQ device is intended in EMS mode for: Prevention or retardation of disuse atrophy Maintaining or increasing range of motion Muscle re-education Relaxation of muscle spasms Increasing local blood circulation Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis and in TENS mode for: Symptomatic relief and management of chronic, intractable pain Post-surgical acute pain Post-traumatic acute pain

Device Story

PHYSIQ is a prescription-use powered muscle stimulator for clinical settings. It utilizes four handpieces, each with two electrodes, to deliver electrical energy to the patient's skin. The device operates in two modes: EMS (Electrical Muscle Stimulation) to cause muscle contraction for therapeutic purposes like atrophy prevention and spasm relaxation; and TENS (Transcutaneous Electrical Nerve Stimulation) to block pain signals to the brain. The operator controls treatment parameters, including intensity (1-50) and duration, via an LCD touch screen. The system includes an AC/DC power supply, CPU controller, and handpieces. It is used on areas such as the back, abdomen, legs, and arms. The device provides non-invasive muscle stimulation and pain management, benefiting patients by aiding recovery and reducing pain.

Clinical Evidence

No clinical data. Bench testing only. Performance verified through validation of output waveforms, basic unit characteristics, and output specifications. Biocompatibility of handpieces confirmed via cytotoxicity, skin irritation, and delayed hypersensitivity testing. Compliance with AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-10, and IEC 60601-1-6 standards demonstrated.

Technological Characteristics

Console-based system with 4 handpieces; Delrin housing. Delivers symmetrical biphasic rectangular electrical pulses. Powered by AC/DC supply (115-230VAC). Features LCD touch screen, CPU controller, and patient override. Connectivity: Standalone. Safety: Type BF electrical type, automatic overload/no-load trips, and shut-off. Complies with AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-10, and IEC 60601-1-6.

Indications for Use

Indicated for patients requiring muscle stimulation for atrophy prevention, range of motion maintenance, muscle re-education, spasm relaxation, circulation improvement, or post-surgical calf stimulation; and for patients requiring pain management for chronic, intractable, post-surgical, or post-traumatic 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

• InMode System with Tone Applicator (K192249)

Submission Summary (Full Text)

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November 25, 2020

El. En. Electronic Engineering SPA Paolo Peruzzi Regulatory Affairs Manager Via Baldanzese 17 Calenzano, FI 50041 Italy

Re: K202079

Trade/Device Name: Physiq Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, GZJ Dated: August 28, 2020 Received: August 31, 2020

Dear Paolo Peruzzi:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Vivek Pinto, PhD 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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# Indications for Use

510(k) Number (if known) K202079

Device Name PHYSIQ

Indications for Use (Describe) Intended Use:

The PHYSIQ device is intended in EMS mode for:

Prevention or retardation of disuse atrophy Maintaining or increasing range of motion Muscle re-education Relaxation of muscle spasms Increasing local blood circulation Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

and in TENS mode for:

Symptomatic relief and management of chronic, intractable pain Post-surgical acute pain Post-traumatic 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) | |

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# 510(k) Summary

Date: November 27, 2020 Submission number: K202079

## Submitter:

El.En. S.p.A. Via Baldanzese, 17 50041 Calenzano (FI), Italy

## Contact:

Paolo Peruzzi Regulatory Affairs Manager & Official Correspondent Phone: [phone] E-mail: [e-mail]

# Date Summary Prepared:

November 10, 2020

## Device Trade Name: PHYSIO

### Manufacturer:

DEKA M.E.L.A. srl Via Baldanzese, 17 50041 Calenzano (FI), Italy

# Common Name:

Electro Muscle Stimulator

### Classification Name:

Powered Muscle Stimulator (IPF) Stimulator, nerve, transcutaneous, for pain relief (GZJ)

### Classification Number:

21 CFR 890.5850 21 CFR 890.5890

### Predicate Devices:

The InMode System with Tone Applicator (K192249)

### Device Description:

The PHYSIQ is a device provided with 4 handpieces by 2 electrodes each intended to employ EMS (Electrical Muscle Stimulation) and TENS (Transcutaneous Electrical Nerve Stimulation) technologies for various medical applications.

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The PhysiO consists of :

- an AC/DC power supply unit,
- EMS/TENS driving electronic board
- CPU controller; ●
- user interface with LCD touch screen, . ●
- 4 EMS/TENS handpieces with interconnecting cables ●

EMS or TENS treatment is enabled at the same time on all 4 handpieces. The operator can choose how many handpieces to use and leave the unused ones in the proper holder.

Through the handpieces the electrical energy is delivered to the patient, which repeatedly contracts muscles by passing electrical currents through electrodes on the affected body area.

During TENS treatments, PHYSIQ generates electrical pulses and transmits it to the electrodes which are in contact with the patient's skin. Consequently, the electrical pulses would then pass through the skin to the underlying peripheral nerves to aid in the blocking of pain signals traveling to the brain.

During EMS treatments, PHYSIQ generates electrical pulses and transmits it to the electrodes in contact with the patient skin, causing the muscle to expand and contract. It is used to relax muscle spasms, prevent or retard atrophy, maintain or increase range of motion, increase local blood circulation, re-educate muscle and provide immediate post-surgical stimulation of calf muscle to prevent venous thrombosis.

Handpieces are directly applied on the area to be treated, such as-upper and lower back, abdomen, legs and arms.

The user interface allows to fully control the treatment parameters. The operator can manage Electro Muscle Stimulation (EMS) or Transcutaneous Electrical Nerve Stimulation (TENS) (OFF or ON from 1 to 50, with selection step of 1).

Treatment time can be changed regardless of the suggested one.

# Intended Use:

The PHYSIQ device is intended in EMS mode for:

- Prevention or retardation of disuse atrophy
- Maintaining or increasing range of motion ●
- . Muscle re-education
- . Relaxation of muscle spasms
- . Increasing local blood circulation
- Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

and in TENS mode for:

- Symptomatic relief and management of chronic, intractable pain ●
- Post-surgical acute pain ●

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- . Post-traumatic acute pain
# Substantial equivalence discussion:

The PHYSIQ device is substantially equivalent to the InMode System with Tone Applicator (K192249)

| Device Trade Name | Subject Device<br>PHYSIQ | Predicate Device<br>K192249<br>The InMode<br>System with Tone<br>Applicator |
|------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design | The PHYSIQ<br>System with<br>consists of AC/DC<br>power supply<br>units, controller<br>and user interface<br>including an LCD<br>touch screen. The<br>delivery of the<br>electrical energy is<br>controlled by a<br>Start/Stop button<br>positioned on the<br>front panel.<br>The System<br>support the<br>following<br>components:<br>• LCD display<br>touch screen<br>• Buzzer<br>• 24V AC/DC<br>power supply<br>• Controller<br>• Fans<br>The System<br>operates while<br>connected to the<br>handpiece. | The InMode<br>System with Tone<br>Applicator consists<br>of an AC/DC<br>power supply unit,<br>controller and user<br>interface including<br>an LCD touch<br>screen. The<br>delivery of the<br>electrical energy is<br>controlled by a<br>Start/Stop button<br>positioned on the<br>front panel.<br>The System<br>support the<br>following<br>components:<br>• LCD display<br>touch screen<br>• Audio<br>loudspeaker<br>• 48V AC/DC<br>power supply<br>• Controller<br>• Fans<br>The System<br>operates while<br>connected to the<br>Tone Applicator. |
| Mechanism of Action | Muscle contraction | Muscle contraction |
| Device Trade Name | Subject Device | Predicate Device<br>K192249<br>The InMode<br>System with Tone<br>Applicator |
| | PHYSIQ | |
| | by electrical<br>pulsing | by electrical<br>pulsing |
| Class, Product Code | Class II, IPF GZJ | Class II, IPF GZJ |
| RX/OTC | Rx only | Rx only |
| Basic Unit Characteristics | | |
| Components<br>Console | The PHYSIQ<br>System consists of<br>the following<br>components:<br>• Console (<br>including<br>controller, power<br>supply units and all<br>needed electronic<br>boards), and user<br>interface including<br>an LCD touch<br>screen.<br>• Four Handpieces<br>connected to the<br>console via a<br>cable. | The InMode<br>System consists of<br>the following<br>components:<br>• Console,<br>including a power<br>supply unit,<br>controller and user<br>interface including<br>an LCD touch<br>screen.<br>• Tone Applicator<br>connected to the<br>console via a<br>cable. |
| Dimensions | | |
| Console [W x H x D]<br>Applicator [L x D] | 34cm x 67cm x<br>90cm<br>Handpiece<br>9cm x 9cm | 35cm x 35cm x<br>100cm<br>Tone Applicator<br>12cm x 10cm |
| Weight: | | |
| Console<br>Applicator | 51.0 Kg<br>Handpiece: 0.5 Kg | 20.0 Kg [44 lbs.]<br>Tone: 0.22 Kg [0.5<br>lbs.] |
| Performance<br>Specifications:<br>Components<br>Console | Main Line<br>Frequency<br>(nominal)<br>50-60Hz | Main Line<br>Frequency<br>(nominal)<br>50-60Hz |
| Device Trade Name | Subject Device<br>PHYSIQ | Predicate Device<br>K192249<br>The InMode<br>System with Tone<br>Applicator |
| | Input Voltage<br>(nominal)<br>115-230VAC<br>Input Current<br>(rms)<br>9A max | Input Voltage<br>(nominal)<br>100-240VAC<br>Input Current<br>(rms)<br>2A |
| Method of line current isolation | AC/DC isolation | Indipendent<br>transformer<br>isolated |
| Electrical Type | Type BF | Type BF |
| Patient Leakage Current - Normal<br>Condition (μΑ) | <100uA patient<br>leakage | <100uA patient<br>leakage |
| Patient Leakage Current - Single<br>Fault Condition (μΑ) | <500uA line<br>leakage | <300uA line<br>leakage |
| Number of output modes | 2 | 2 |
| Number of Output channels | 4 | 2 |
| Synchronous or alternating | Synchronous | Not Publicly<br>Available |
| Method of Channel Isolation | Through AC/DC<br>and transformers | Through<br>transformers and<br>isolators |
| Regulated Current or Regulated<br>Voltage (output signals only) | Regulated voltage<br>on all channels<br>with current limit | Regulated voltage<br>on all channels<br>with current limit |
| Software/Firmware/Microprocessor<br>Control | Yes | Yes |
| Automatic Overload Trip | Yes | Yes |
| Automatic No-Load Trip | Yes | Yes |
| Automatic Shut Off | Yes, On/off switch | Yes, On/off switch |
| Device Trade Name | Subject Device<br>PHYSIQ | Predicate Device<br>K192249<br>The InMode<br>System with Tone<br>Applicator |
| Patient Override Control | Yes | Yes |
| Indicator Display | Yes | Yes |
| On/Off Status | Yes | Yes |
| Battery | No battery | No battery |
| Voltage/Current level | Yes, voltage levels | Yes, voltage levels |
| Timer Range (minutes) | 0-60 minutes | 0-60 minutes |
| Compliance with 21 CFR 898 | YES | Not Publicly<br>Available |
| Compliance with 21 CFR 882.5890<br>(GZJ) | Yes | Yes |
| Compliance with 21 CFR 890.5850<br>(IPF) | Yes | Yes |
| Electrode area | 11 cm2 | 12 cm2 |
| Housing Material | Delrin | PC Makrolon 2458 |
| Output Specifications | | |
| EMS output mode | | |
| Waveform | Symmetrical<br>Biphasic<br>Waveform | Symmetrical<br>Biphasic<br>Waveform |
| Pulse Shape | Rectangular | Rectangular |
| Maximum output voltage<br>(± 10%) | 50V @ 500Ω<br>50V @2kΩ<br>50V@10kΩ | 56V @ 500Ω<br>56V @2kΩ<br>56V @ 10kΩ |
| Device Trade Name | Subject Device<br>PHYSIQ | Predicate Device<br>K192249<br>The InMode<br>System with Tone<br>Applicator |
| Maximum output<br>current (± 10%) | 100mA @500 Ω<br>25mA @2 kΩ<br>5mA @10 kΩ | 112mA @500 Ω<br>28mA @2 kΩ<br>5.6mA @10 kΩ |
| Pulse Width (μs) | 25 to 400 μs | 20 to 400 μs |
| Frequency (Hz) | 3 to 200 Hz | 3 to 200 Hz |
| Net Charge @ 500 ohms<br>(µC/pulse)] | 0μC @ 500Ω | 0μC @ 500Ω |
| Maximum Phase Charge (µC) | 40 μC @ 500Ω | 44.8 μC @ 500Ω |
| Maximum Current Density<br>(mA/cm2) | 1.1 mA/cm2 @<br>500Ω<br>Surface = 11cm² | 1 mA/cm2 @<br>500Ω<br>Surface = 12cm² |
| Maximum Power Density<br>(mW/cm2)] | 6.4mW/cm2<br>@500Ω | 55mW/cm2<br>@500Ω |
| Burst Mode (i.e., pulse trains)<br>a. Pulses per burst<br>b. Bursts per second<br>c. Burst duration (seconds)<br>d. Duty Cycle [Line (b) x Line (c)] | Yes:<br>a. 3 - 200<br>b. 1<br>c. 0.2-60 s<br>d. Time on / off | Yes:<br>a. 3 - 200<br>b. 1<br>c. 1-60 s<br>d. Time on / off |
| ON time | 0.2 - 60 s | 1 - 60 s |
| OFF time | 0.5 - 60 s | 1 - 60 s |
| Treatment Time (min) -…