(93 days)
No
The document describes a microprocessor-controlled electro-stimulator with various stimulation modalities. While it stores and downloads compliance data for physician review, there is no mention of AI or ML being used for data analysis, treatment adjustments, or any other function. The decision-making for treatment adjustments is explicitly stated to be made by the physician based on the compliance report.
Yes
The device is described as an electro-stimulator intended for treating patients that have acute and chronic pain, edema, tight musculature, muscle spasms, and muscular weakness due to disuse atrophy, which are all therapeutic applications.
No
The device is described as a non-invasive medium/low frequency interferential muscle stimulator intended for treating various physical conditions such as pain, edema, and muscle spasms, and includes modalities like neuromuscular electrical stimulation and pulsed direct current stimulation. Its primary functions are therapeutic, aimed at alleviating symptoms and improving physical function, rather than diagnosing conditions.
No
The device description explicitly states it is a "microprocessor controlled dual channel Interferential electro-stimulator" and lists hardware accessories such as lead wires, electrode pads, battery charger/modem, phone cable, and power supply. This indicates it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The listed applications (pain relief, muscle relaxation, range of motion, blood circulation, preventing atrophy, re-educating muscles, preventing thrombosis, edema reduction) are all related to physical therapy and rehabilitation, directly treating the patient's body.
- Device Description: The device is described as an "electro-stimulator" that applies electrical stimulation to the patient. This is a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device directly interacts with the patient's body for therapeutic effect.
N/A
Intended Use / Indications for Use
The IF 3Wave Interferential Stimulator System is intended for:
Interferential stimulation can be used for the following applications:
- Relieve acute pain .
- . Relieve and manage chronic pain
- Relax muscle spasms .
- Maintain and increase the range of motion .
- Increase local blood circulation .
Neuromuscular stimulation can be used for the following applications:
- Relax muscle spasms .
- Prevent or retard disuse atrophy .
- Increase local blood circulation .
- Re-educate muscles .
- Maintain or increase the range of motion .
- Prevent venous thrombosis using immediate postsurgical stimulation on calf . muscles
Pulsed direct current stimulation can be used for the following applications:
- Reduction of edema (under negative electrode) t
- Reduction of muscle spasm .
- Influencing local blood circulation (under negative electrode) .
- Retardation or prevention of disuse atrophy .
- Facilitation of voluntary motor function .
- Maintenance or increase of range of motion .
Interferential and Neuromuscular combination stimulation can be used for the following applications:
- Reduction of edema (under negative electrode) .
- Reduction of muscle spasm .
Product codes
GZJ, IPF, LIH
Device Description
The IF 3 Wave is a non-invasive medium/low frequency interferential muscle rie it -> wave is a intended for treating patients that have acute and chronic pain, edema, tight musculature, muscle spasms and muscular weakness due to disuse atrophy. The IF 3 Wave stimulator is a microprocessor controlled dual channel Interferential electro-stimulator with neuro-muscular and pulse direct current micronital expabilities. It will offer 4 separate electro-therapy stimulation modalities. Stimulation capacificies: 17 Will on P), neuromuscular electrical stimulation (NMES), r neso direct current (PDC) electrical stimulation, and a combination of interferential and neuromuscular electrical stimulation (IF/NMES).
The IF 3 Wave will be capable of storing device settings, use, and compliance data for up to 90 days. It will be capable of down loading the above compliance date through a up to 90 days. which is contained within the battery charger base. Once per phone mic modelin, will be instructed to download the stored data from their device, month, the patient will over compliance report which is forwarded to their physicians for which will ereate a paysician will review the report and provide adjustment to the patient treatment regimen and device setting accordingly.
Accessories provided with the IF 3 Wave include lead wires, electrode pads, Accessories proTracu wik, battery charger/modem, phone cable, power supply, and a users manual.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
K926510, K923914, K921668, K872976, K970426
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
KC50046
APR 1 3 2005
Summary of Safety and Effectiveness:
Summary of Safety and Effectiveness
Applicant Information
Compex Technologies, Inc. 1811 Old Highway 8 New Brighton, MN 55112 Phone: (612) 638-0590 (612) 638-0479 FAX:
Contact Person
Brian J. Edwards, M.S. Director of Regulatory Affairs & Quality Assurance
Date Summary Prepared
September 1, 2004
Device identification
| Trade / Proprietary Name: | IF 3Wave Interferential Muscle Stimulator System,
Model 7110S |
|---------------------------|------------------------------------------------------------------|
| Common / Usual Name: | Muscle and Interferential Current |
| Classification Name: | 21 CFR 890.5850 "Powered Muscle Stimulator" |
| Product Classification: | Class II |
| Product Code: | IPF |
1
Legally Market Predicate Devices
| Predicate Device | 510(k) Number / Clearance Date |
|---|---|
| Staodyne, Inc. EMS+2 Neuromuscular | |
| Stimulation System | K926510 / August 11, 1993 |
| Medical Devices, Inc. Model IF-II | |
| Interferential Stimulation System | K923914 / November 6, 1992 |
| Staodyne, Inc. Model SporTX Pulsed | |
| Direct Current and TENS Stimulator | K921668 / August 3, 1992 |
| Axelgaard Manufacturing Company | |
| TENS Pals Plus Electrodes | K872976 / September 22, 1987 |
| Axelgaard Manufacturing Company | |
| Valutrode Electrodes | K970426 / May 9, 1997 |
The IF 3Wave Interferential Stimulator System, Model 7110S is comparable in type and function and are substantially equivalent to the following predicate devices.
Device Description
The IF 3 Wave is a non-invasive medium/low frequency interferential muscle rie it -> wave is a intended for treating patients that have acute and chronic pain, edema, tight musculature, muscle spasms and muscular weakness due to disuse atrophy. The IF 3 Wave stimulator is a microprocessor controlled dual channel Interferential electro-stimulator with neuro-muscular and pulse direct current micronital expabilities. It will offer 4 separate electro-therapy stimulation modalities. Stimulation capacificies: 17 Will on P), neuromuscular electrical stimulation (NMES), r neso direct current (PDC) electrical stimulation, and a combination of interferential and neuromuscular electrical stimulation (IF/NMES).
The IF 3 Wave will be capable of storing device settings, use, and compliance data for up to 90 days. It will be capable of down loading the above compliance date through a up to 90 days. which is contained within the battery charger base. Once per phone mic modelin, will be instructed to download the stored data from their device, month, the patient will over compliance report which is forwarded to their physicians for which will ereate a paysician will review the report and provide adjustment to the patient treatment regimen and device setting accordingly.
Accessories provided with the IF 3 Wave include lead wires, electrode pads, Accessories proTracu wik, battery charger/modem, phone cable, power supply, and a users manual.
2
Technical Characteristics
The IF functional mode of the IF 3Wave is substantially equivalent to the functional mode of the Rehabilicare IF-II device.
| Interferential Modality. | ||
|---|---|---|
| IF-II | ||
| Model 7100S | IF 3Wave | |
| Model 7110S | ||
| 510(k) Number | K923914 | |
| Manufacturer | Medical Devices, Inc. | Compex Technologies, Inc. |
| Power Source | 4 AA rechargeable batteries | |
| Line Powered Repack | Lithium ion polymer rechargeable | |
| battery. | ||
| Weight | 12 oz, with battery | 12 oz, with battery |
| Dimensions | 3.2 x 5.2 x 1.15 in. | 3.89 x 6.33 x 1.42 in |
| Case Materials | ABS/PC Blend | Same |
| Patient Leakage Current* | ||
| Normal | Unknown |