(121 days)
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
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.
The provided text describes a 510(k) premarket notification for the PHYSIQ device, which is a powered muscle stimulator and transcutaneous electrical nerve stimulator. The purpose of a 510(k) submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. This type of submission generally relies on non-clinical performance data rather than extensive clinical studies with acceptance criteria based on patient outcomes.
Therefore, the acceptance criteria and study detailed below will focus on the non-clinical performance benchmarks used to establish substantial equivalence with the predicate device, rather than clinical performance metrics typically found in efficacy trials.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the PHYSIQ device are based on demonstrating similar performance characteristics to its predicate device, The InMode System with Tone Applicator (K192249), and compliance with relevant safety standards. The reported device performance aligns with these criteria.
| Acceptance Criteria Category | Specific Acceptance Criteria (Demonstrated by Equivalence to Predicate or Standard Compliance) | Reported Device Performance (PHYSIQ) |
|---|---|---|
| Indications for Use | Must have the same indications for use as the predicate device. | Same indications for use in both EMS and TENS modes for similar medical applications (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; Symptomatic relief and management of chronic, intractable pain, Post-surgical acute pain, Post-traumatic acute pain). |
| Principle of Operation | Must operate on the same principle as the predicate device. | Uses electrical muscle stimulation (EMS) and transcutaneous electrical nerve stimulation (TENS) technologies. Mechanism of action is muscle contraction by electrical pulsing, same as predicate. |
| Device Design | Similar design components and functionality. | Consists of an AC/DC power supply, EMS/TENS driving electronic board, CPU controller, user interface with LCD touch screen, and 4 EMS/TENS handpieces. This is comparable to the predicate's console, controller, user interface, and Tone Applicator. |
| Basic Unit Characteristics | Similar electrical and physical specifications. | Console: Main Line Frequency (50-60Hz), Input Voltage (115-230VAC), Input Current (9A max), AC/DC isolation, Type BF Electrical Type, Patient Leakage Current ( |
§ 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).