(222 days)
Not Found
No
The summary describes a standard electrical muscle stimulator with no mention of AI or ML capabilities.
Yes
The "Intended Use / Indications for Use" section explicitly lists several therapeutic applications such as relaxation of muscle spasms, prevention of disuse atrophy, and increasing local blood circulation.
No
The document describes the device's function as therapeutic (e.g., muscle stimulation, increasing range of motion) rather than for diagnosing a condition.
No
The device description explicitly states it is a "Square wave generator designed for neuromuscular electrical stimulation (NMES)" and stimulates tissues through "cutaneous electrodes connected by lead wires to the generator." This indicates the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The listed indications (muscle relaxation, atrophy prevention, blood circulation increase, muscle re-education, post-surgical stimulation, range of motion) all relate to treating or affecting the human body directly. IVDs are used to examine specimens from the human body (like blood, urine, tissue) to provide information about a person's health status.
- Device Description: The description clearly states it's a "Square wave generator designed for neuromuscular electrical stimulation (NMES)" that stimulates tissues through "cutaneous electrodes." This is a description of a therapeutic device that applies energy to the body, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, the Smartwave MS 2000 Muscle Stimulator is a therapeutic device, not an IVD.
N/A
Intended Use / Indications for Use
-
- Relaxation of muscle spasms
-
- Prevention or retardation of disuse atrophy
-
- Increasing local blood circulation
-
- Muscle re-education
-
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
-
- Maintaining or increasing range of motion
Product codes
IPF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
K04/063
neuromuscular tissues through cutaneous electrodes connected by
lead wires to the generator.
Relaxation of muscle spasms.
DEC
| C - 1 2004 | |
|---|---|
| Attachment A | |
| 510(k) Summary of Safety and Effectiveness | |
| Date Prepared: | April 19, 2004 |
| Submitter: | Newwave Medical, LLC |
| 620 Haggard ST. STE 614 | |
| Plano, TX 75074 | |
| (972) 516-8383 | |
| Contact Person: | Robert Armstrong |
| Trade (Proprietary) Name: | Smartwave MS 2000 |
| Common/Classification Name: | Powered Muscle Stimulator |
| Device Classification: | Class II |
| Predicate Device: | Staodyn, Inc. |
| Description of Device: | The Smartwave MS 2000 Muscle |
| Stimulator is a Square wave | |
| generator designed for | |
| neuromuscular electrical stimulation | |
| (NMES). The MS 2000 stimulates |
Statement of Intended Use:
Prevention of retardation of disuse Atrophy. Increasing local blood circulation. Muscle re-education. Immediate post surgical stimulation of calf muscles to prevent venous thrombosis. Maintaining or increasing range of Motion. Technological Characteristics: The new device has the same Technological characteristics as the Predicate device. See table 1 (next Page) for a summary of the Technological characteristics of the New device in comparison to those of The predicate device.
A 2
1
| Comparison of the Smartwave MS 2000 and Staodyn EMS +2 | ||
|---|---|---|
| New Device | Marketed Device | |
| 1) 510 (k) Number | This Submission | K926510 |
| 2) Device Name | Smartwave MS 2000 | EMS +2 |
| 3) Manufacturer | Newwave Medical, LLC | Staodyn Inc. |
| 4) Power Source | 9V | 9V |
| Optional wall adapter | 100-120vac, 50-60Hz | no |
| Method of line current | ||
| Isolation | Transformer coupled | |
| Patient leakage current | ||
| (w/adapter) | ||
| Normal condition | 3.2uA | |
| Single fault | 6.5uA | |
| 5) # of output modes | Pulsed DC, AC, Russian Stim | Pulsed DC, AC |
| 6) # of output channels | 1 or 2 | 1 or 2 |
| Synchronous | yes | yes |
| Reciprocal | no | no |
| 7) Computerized | no | no |
| 8) Software Provided | no | no |
| 9) Constant Current (+5%) | yes | yes |
| 10) Constant Voltage | no | no |
| 11) Max Output Current | ||
| each channel | 57.2mA-500~ | |
| 17.8mA-2K~ | 95.2mA-500~ | |
| 46.8mA-2K~ | ||
| (+5%) | 3.8mA-10K~ | 9.63mA-10K~ |
| 12) Max Output Voltage | ||
| baseline-to-peak | 28.6V-500~ | |
| 35.5V-2K~ | ||
| 38.3V-10K~ | 47.6V-500~ | |
| 93.6V-2K~ | ||
| 96.3V-10K~ | ||
| 13) Channel isolation | Independent isolation transformer | Capacitor coupled |
| 14) Line Current isolation | Transformer coupled | N/A |
| 15) Automatic overload trip | no | no |
| 16) Automatic no load trip | yes | |
| (when the unit is turned on, if | ||
| it is not used, it will turn itself off | ||
| after 10 minutes.) | no | |
| 17) Patient override control | yes (by turning off unit) | yes (by turning off unit) |
| 18) Max leakage current (uA) | ||
| chassis (input) | N/A | N/A |
| electrodes (output) | N/A | N/A |
| 19) Indicator display | LCD | no |
| unit functioning | yes | yes (red LEDs) |
| low battery indicator | yes (Lo b displayed @ |