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510(k) Data Aggregation
K Number
K202079Device Name
Physiq
Manufacturer
El. En. Electronic Engineering SPA
Date Cleared
2020-11-25
(121 days)
Product Code
IPF, GZJ
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
El. En. Electronic Engineering SPA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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 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.
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