(121 days)
Not Found
No
The device description and performance studies focus on standard electrical stimulation technologies (EMS and TENS) and basic device functionality. There is no mention of AI, ML, or any features that would suggest the use of such technologies for analysis, control, or adaptation.
Yes
The device explicitly states its intended use 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 symptomatic relief and management of chronic, intractable pain, post-surgical acute pain, and post-traumatic acute pain, all of which are therapeutic applications.
No.
The provided text describes the PHYSIQ device as being used for therapeutic purposes, such as pain relief, muscle re-education, and prevention of disuse atrophy, via EMS and TENS technologies. There is no mention of the device being used to diagnose any condition or disease.
No
The device description explicitly lists multiple hardware components including an AC/DC power supply unit, EMS/TENS driving electronic board, CPU controller, user interface with LCD touch screen, and 4 EMS/TENS handpieces with interconnecting cables. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the PHYSIQ device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples from the human body. The core function of an IVD is to examine biological samples (like blood, urine, tissue, etc.) to provide information about a person's health or condition.
- The PHYSIQ device applies electrical stimulation to the body. The description clearly states that the device delivers electrical energy through electrodes placed on the skin to stimulate muscles (EMS) or nerves (TENS). It does not analyze any biological samples.
- The intended uses are therapeutic. The listed intended uses (muscle stimulation, pain relief) are therapeutic interventions, not diagnostic tests.
Therefore, the PHYSIQ device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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
Product codes (comma separated list FDA assigned to the subject device)
IPF, GZJ
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.
The PHYSIQ 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper and lower back, abdomen, legs and arms.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Performance Data: None
Non-Clinical Performance Data: Bench testing was conducted to demonstrate that the PHYSIQ performs as expected under anticipated conditions of use and to verify that the device performance meets the device design requirements. The device was tested for validation of output waveform, basic unit characteristics, and output specifications. The bench testing results demonstrated that the device performs as expected under anticipated conditions of use.
The biocompatibility of the PHYSIQ handpieces was justified using a biocompatibility assessment performed on representative test article.
Test Summary Conclusions:
- Cytotoxicity by elution test: Qualitative and quantitative evaluation showed no cytotoxic effect. Not Cytotoxic.
- In vivo skin irritation test in albino rabbit – single exposure: Animals exposed to the test article showed no local toxic effects. Not irritant.
- Delayed Hypersensitivity Test (GPMT): Animals exposed to the test article showed no sensitizing effects. Not sensitizing.
In addition, the PHYSIQ has been tested and found in compliance with the following standards:
- AAMI/ANSI ES60601-1- Medical electrical equipment Part 1: General requirements for basic safety and essential performance.
- IEC 60601-1-2 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests.
- IEC 60601-2-10 - Medical electrical equipment - Part 2-10: Particular requirements for basic safety and essential performance of nerve and muscle stimulators.
- IEC 60601-1-6 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Usability.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 890.5850 Powered muscle stimulator.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" on the bottom.
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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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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3
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: +39.055.8826807 E-mail: p.peruzzi@elen.it
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.
4
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 ●
5
- . 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
PHYSIQ | Predicate Device
K192249
The InMode
System with Tone
Applicator |
|------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design | The PHYSIQ
System with
consists of AC/DC
power supply
units, 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
support the
following
components:
• LCD display
touch screen
• Buzzer
• 24V AC/DC
power supply
• Controller
• Fans
The System
operates while
connected to the
handpiece. | The InMode
System with Tone
Applicator 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
support the
following
components:
• LCD display
touch screen
• Audio
loudspeaker
• 48V AC/DC
power supply
• Controller
• Fans
The System
operates while
connected to the
Tone Applicator. |
| Mechanism of Action | Muscle contraction | Muscle contraction |
| Device Trade Name | Subject Device | Predicate Device
K192249
The InMode
System with Tone
Applicator |
| | PHYSIQ | |
| | by electrical
pulsing | by electrical
pulsing |
| Class, Product Code | Class II, IPF GZJ | Class II, IPF GZJ |
| RX/OTC | Rx only | Rx only |
| Basic Unit Characteristics | | |
| Components
Console | The PHYSIQ
System consists of
the following
components:
• Console (
including
controller, power
supply units and all
needed electronic
boards), and user
interface including
an LCD touch
screen.
• Four Handpieces
connected to the
console via a
cable. | The InMode
System consists of
the following
components:
• Console,
including a power
supply unit,
controller and user
interface including
an LCD touch
screen.
• Tone Applicator
connected to the
console via a
cable. |
| Dimensions | | |
| Console [W x H x D]
Applicator [L x D] | 34cm x 67cm x
90cm
Handpiece
9cm x 9cm | 35cm x 35cm x
100cm
Tone Applicator
12cm x 10cm |
| Weight: | | |
| Console
Applicator | 51.0 Kg
Handpiece: 0.5 Kg | 20.0 Kg [44 lbs.]
Tone: 0.22 Kg [0.5
lbs.] |
| Performance
Specifications:
Components
Console | Main Line
Frequency
(nominal)
50-60Hz | Main Line
Frequency
(nominal)
50-60Hz |
| Device Trade Name | Subject Device
PHYSIQ | Predicate Device
K192249
The InMode
System with Tone
Applicator |
| | Input Voltage
(nominal)
115-230VAC
Input Current
(rms)
9A max | Input Voltage
(nominal)
100-240VAC
Input Current
(rms)
2A |
| Method of line current isolation | AC/DC isolation | Indipendent
transformer
isolated |
| Electrical Type | Type BF | Type BF |
| Patient Leakage Current - Normal
Condition (μΑ) |