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510(k) Data Aggregation
(61 days)
NuBODY Skin Toning Device
NuBODY Skin Toning Device is intended for body skin stimulation and is indicated for over-the-counter cosmetic use.
NuBODY Skin Toning Device is intended for body skin stimulation and is indicated for over-the-counter cosmetic use. Four (4) spherical electrodes, fixed on the NuBODY device main body, deliver low level electrical impulses (microcurrent) to targeted locations on the body.
This document describes a 510(k) premarket notification for the NuBODY Skin Toning Device, claiming substantial equivalence to the NuFACE Plus device. As such, the study focuses on characterizing the new device's technical specifications and safety standards rather than a clinical efficacy trial.
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1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a separate section. Instead, the performance is demonstrated by comparing the new device (NuBODY) to a legally marketed predicate device (NuFACE Plus) based on their technological characteristics, basic unit characteristics, and output specifications. The assertion is that NuBODY meets the predicate's performance by being "the same, or similar," and that "differences do not alter the clinical utility."
Therefore, the "acceptance criteria" are implied to be that the NuBODY device should have comparable performance characteristics and meet the same safety standards as the NuFACE Plus predicate device.
| Acceptance Criteria (Implied: Comparable to NuFACE Plus Predicate) | Reported NuBODY Device Performance |
|---|---|
| Technological Characteristics: | |
| - Power Source | Rechargeable, non-replaceable, lithium-ion battery (Same as predicate) |
| - Microcurrent Delivery | Four (4) smooth, chrome-plated, spherical electrodes (Predicate has two spheres, but both deliver microcurrent) |
| - Waveform | Continuous alternating microcurrent delivered in a burst of positive pulses followed by a burst of negative pulses (Same as predicate) |
| Basic Unit Characteristics: | |
| - Power Source | Internal rechargeable Lithium ion battery (Same as predicate) |
| - Method of Line Current Isolation | Type BF (Same as predicate) |
| - Patient Leakage Current | N/A - Battery operated (Same as predicate) |
| - Number of Output Channels | 1 (Same as predicate) |
| - Regulated Current or Voltage | Both (Same as predicate) |
| - Software/Firmware/Microprocessor Control | Yes (Same as predicate) |
| - Automatic Overload Trip | Not required due to circuit design (Same as predicate) |
| - Automatic No-Load Trip | Yes (Same as predicate) |
| - Automatic Shut Off | Yes (Same as predicate) |
| - Patient Override Control | Yes (Same as predicate) |
| - Indicator Display (On/Off, Low Battery, Voltage/Current Level) | All Yes (Same as predicate) |
| - Automatic Shut-Off (minutes) | Yes (5 minutes) (Predicate is 20 minutes; this difference is presented without an explicit "acceptance criterion" but is deemed not to alter clinical utility from the overall conclusion) |
| - Compliance with Voluntary Standards | IEC 60601-1, IEC 60601-1-2, IEC 60529, IEC 60601-2-10, ISO 14971, IEC 60601-1-6, IEC 62366 (More comprehensive than predicate which listed IEC 60601-1, IEC 60601-1-2, demonstrating compliance with relevant standards.) |
| - Compliance with 21 CFR 898 | Yes (Same as predicate) |
| - Housing Materials and Construction | Thermoplastic (Same as predicate) |
| Output Specifications: | |
| - Waveform (e.g., pulsed monophasic, biphasic) | Monophasic waveform that is delivered in a burst of pulses (Same as predicate) |
| - Shape (e.g., rectangular, spike, rectified sinusoidal) | Voltage Modulated Square (Same as predicate) |
| - Maximum Output Voltage | 28 VDC (Same as predicate) |
| - Output Current when not stimulating |
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