(200 days)
The Visionbody System is a device intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only.
The Visionbody System is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of the training programs or operational parameters are designed or ailing muscles and its use on such muscles is contraindicated.
The Visionbody System's electrical impulses allow the triggering of action potentials on motoneurons of motor nerves (excitations). These excitations of motoneurons are transmitted to the muscle fibers via the motor endplate where they generated mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.
The Visionbody System is a wireless electrical muscle stimulation device for health and fitness applications. The main components are the Visionbody Box, the Visionbody Software and the choice of a Visionbody garment, whether a Visionbody Powersuit, Visionbody PowerPants or Visionbody Power Vest, dependent on a user's personal choice and needs. The Visionbody Box delivers a safe low to mid frequency electrical current to the electrodes in a Visionbody garment. The Visionbody uses electrical muscle stimulation (EMS) and electrical muscle activation (EMA) technologies to provide a streamlined approach to a user's fitness goals, especially regarding body composition, strength and endurance. Underlying to both these technologies are safe electrical impulses, which stimulate muscle contractions equating to muscle workouts.
The provided text is a 510(k) Summary for the Visionbody system, a powered muscle stimulator. It details a comparison with a predicate device (Katalyst Training System Model 1) and two reference devices (FM-B2403A EMS and R-E1 EMS).
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative manner as one might find for diagnostic performance (e.g., sensitivity, specificity thresholds). Instead, the acceptance criteria are implicitly demonstrated through compliance with various safety and performance standards and by showing substantial equivalence to a legally marketed predicate device.
The "reported device performance" is primarily the device's compliance with safety standards and its functional characteristics. The comparison table directly addresses this.
| Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (Visionbody®) | Comparison to Predicate/Reference |
|---|---|---|---|
| Intended Use | Stimulate healthy muscles to improve/facilitate muscle performance; for adults only; not for therapy/medical conditions. | Same as predicate. | Similar |
| Classification | Class II, Powered muscle stimulator (21 CFR 890.5850), Product Code NGX. | Class II, Powered muscle stimulator (21 CFR 890.5850), Product Code NGX. | Similar |
| Compliance with Voluntary Standards | Compliance with relevant IEC and ISO standards for electrical safety, EMC, and biocompatibility. | Yes (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 10993-1, ISO 10993-5, ISO 10993-10, IEC 62366). | Similar to predicate (both comply with core electrical safety and EMC standards). |
| Software Level of Concern | Moderate (failure leads to delayed medical care). | Moderate level of concern. | Not directly compared, but implies software validation and verification successfully addressed this. |
| Maximum Output Voltage | Within safety limits of IEC 60601-2-10. | 60 V @ 500Ω, 60 V @ 2kΩ, 60 V @ 10kΩ | Lower than predicate (Katalyst: 60 V @ 500 Ω, 100 V @ 2 kΩ, 100 V @ 10 kΩ). Deemed safe as both comply with IEC 60601-2-10 limits. |
| Maximum Output Current | Within safety limits of IEC 60601-2-10. | 120 mA ±10% @ 500Ω, 30 mA ±10% @ 2kΩ, 6 mA ±10% @ 10kΩ | Similar to predicate @ 500Ω (Katalyst: 120 mA @ 500 Ω). Lower than predicate @ 2kΩ and 10kΩ. Deemed safe/effective. |
| Pulse Width | Acceptable range for muscle stimulation. | 150 - 500 µs | Different from predicate (Katalyst: 250 - 375 µs). Both support adjustable pulse width, within acceptable ranges. |
| Frequency Range | Acceptable range for muscle stimulation. | 4 - 100 Hz | Similar to predicate (Katalyst: 5 - 105 Hz) and reference devices (R-E1: 1-110 Hz, FM-B2403A: |
§ 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).