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510(k) Data Aggregation
(222 days)
SMARTWAVE MS 2000
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- Relaxation of muscle spasms
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- Prevention or retardation of disuse atrophy
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- Increasing local blood circulation
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- Muscle re-education
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- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
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- Maintaining or increasing range of motion
The Smartwave MS 2000 Muscle Stimulator is a Square wave generator designed for neuromuscular electrical stimulation (NMES). The MS 2000 stimulates neuromuscular tissues through cutaneous electrodes connected by lead wires to the generator.
This 510(k) submission (K041063) for the Smartwave MS 2000 Muscle Stimulator does not contain a study that demonstrates the device meets specific acceptance criteria through performance evaluation. Instead, the submission relies on demonstrating substantial equivalence to a predicate device (Staodyn EMS +2, K926510).
The acceptance criteria are implied by the comparison to the predicate device, where the new device is expected to have similar technological characteristics and performance specifications for its intended use. There are no explicit performance metrics stated as "acceptance criteria" against which the new device's performance is measured in a clinical or analytical study within this document.
Here's an breakdown of the information based on the provided text, keeping in mind the absence of a direct study proving performance against explicit acceptance criteria:
1. Table of Acceptance Criteria and Reported Device Performance
As there are no explicit "acceptance criteria" presented as objective performance targets in this document, and no direct performance study, this table cannot be fully populated as requested. However, a comparison of the new device's specifications against the predicate device's specifications (which serve as the de-facto "acceptance criteria" for substantial equivalence) can be presented:
| Feature/Parameter | Acceptance Criteria (Predicate Device K926510 - Staodyn EMS +2) | Reported Device Performance (Smartwave MS 2000) |
|---|---|---|
| Power Source | 9V | 9V |
| Optional Wall Adapter | No | Yes (100-120vac, 50-60Hz) |
| Method of Line Current Isolation | Transformer coupled | Transformer coupled |
| Patient Leakage Current | Not specified | Normal condition: 3.2uA; Single fault: 6.5uA (with adapter) |
| # of Output Modes | Pulsed DC, AC | Pulsed DC, AC, Russian Stim |
| # of Output Channels | 1 or 2 | 1 or 2 |
| Synchronous Output | Yes | Yes |
| Reciprocal Output | No | No |
| Computerized | No | No |
| Software Provided | No | No |
| Constant Current (+5%) | Yes | Yes |
| Constant Voltage | No | No |
| Max Output Current (500Ω) | 95.2mA | 57.2mA |
| Max Output Current (2KΩ) | 46.8mA | 17.8mA |
| Max Output Current (10KΩ) | 9.63mA | 3.8mA |
| Max Output Voltage (500Ω) | 47.6V | 28.6V |
| Max Output Voltage (2KΩ) | 93.6V | 35.5V |
| Max Output Voltage (10KΩ) | 96.3V | 38.3V |
| Channel Isolation | Capacitor coupled | Independent isolation transformer |
| Line Current Isolation | N/A | Transformer coupled |
| Automatic Overload Trip | No | No |
| Automatic No Load Trip | No | Yes (turns off after 10 min if not used) |
| Patient Override Control | Yes (by turning off unit) | Yes (by turning off unit) |
| Indicator Display | No (rotary dials) | LCD (0 to 35 displayed intensity level) |
| Unit Functioning Indicator | Yes (red LEDs) | Yes |
| Low Battery Indicator | Yes (yellow LED on) | Yes (Lo b displayed @ |
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