(129 days)
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No
The document describes a standard electrical stimulator with adjustable output and waveform controlled by a microprocessor. There is no mention of AI, ML, or any adaptive or learning capabilities.
Yes
The device is described as a Transcutaneous Electrical Nerve Stimulator (TENS) and Neuromuscular electrical stimulation (NMS) device, with indications for use that include symptomatic relief of chronic intractable pain, relaxing muscle spasms, preventing disuse atrophy, increasing local blood circulation, re-educating muscles, and maintaining or increasing the range of motion. These are all therapeutic applications.
No.
The device is described as a Transcutaneous Electrical Nerve Stimulator (TENS) and Neuromuscular Electrical Stimulator (NMS) used for symptomatic relief, muscle relaxation, prevention of disuse atrophy, increased circulation, muscle re-education, and range of motion. These are therapeutic applications, not diagnostic ones.
No
The device description explicitly states it is an "Electrical Stimulator" and describes hardware components like a "stimulus generator" and "output port" that transmit current to the patient's skin. This indicates it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that this device is an electrical stimulator that applies stimulation to the patient's skin using electrodes. It is used for pain relief and muscle stimulation.
- Intended Use: The intended uses listed (symptomatic relief of chronic intractable pain, relaxing muscle spasms, preventing disuse atrophy, increasing local blood circulation, re-educating muscles, maintaining or increasing range of motion) are all related to applying electrical stimulation directly to the body, not analyzing samples taken from the body.
Therefore, this device falls under the category of a therapeutic electrical stimulator, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The indication for use of this device includes the prescription TENS, NMS, Interferential stimulation as follows:
Transcutaneous Electrical Nerve Stimulator (TENS/IF TENS) & Program can be used for the following applications :
· For symptomatic relief of chronic intractable pain.
Neuromuscular electrical stimulation (NMS) & Program 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
Product codes
GZJ, IPF, LIH
Device Description
The Well-Life 4 Channels Multiple Modes Electrical Stimulator/ Model: WL-2504A is the The Well-che of Channels Matiple Motion Leorve stimulator(TEMS) and Interferential Combination (IF) used for pain relief and/or powered muscle stimulator(EMS) by applying Stimulation (if ) ascu for pain rollor which are attached on the patient's skin. The output and waveform is adjustable according to the situation of patient.
The Well-Life 4 Channels Multiple Modes Electrical Stimulator/ Model: WL-250A consisted The Well-Life + Chamble Modisle Model Eloctive. The stimulus generator generator generator summer mainly of two parts. the stimulas gonorator, close. The output port transmits the output current oulput current Specificular to the patient's skin so as to transmit this stimulus current to the patient for pain relief or muscle stimulation of intended use purpose.
The Well-Life 4 Channels Multiple Modes Electrical Stimulator/ Model: WL-2504 includes The Well-Life + Channels Modes as mentioned on the comparison table. These its moin several unlerent operation modes as montonou on the microprocessor as its main control unit.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
WL-2203A (K033857), WL-2204A(K033857), WL-2204A -P2(K033857), WL-2206D(K092763)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).
0
510(K) Summary
This 510(k) Summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K100399.
- Submitter's Identifications:
| Company Name: | Well Life Healthcare Limited | ||
|---|---|---|---|
| Contact person: | Jenny Hsieh | ||
| Address: | 1FL., No.16, Lane 454, Jungjeng Rd., Yunghe City, Taipei County, | ||
| Taiwan, R.O.C. | |||
| TEL No.: | 886-2-2928-2112 | ||
| Fax No.: | 886-2-2928-1880 | ||
| E-mail address: | jenny@welllifehealthcare.com.tw |
-
- Name of the Device:
4 Channels Multiple Modes Electrical Stimulator/ Model: NuvoStim IV, WL-2504A
- Name of the Device:
-
- Device Description:
The Well-Life 4 Channels Multiple Modes Electrical Stimulator/ Model: WL-2504A is the The Well-che of Channels Matiple Motion Leorve stimulator(TEMS) and Interferential Combination (IF) used for pain relief and/or powered muscle stimulator(EMS) by applying Stimulation (if ) ascu for pain rollor which are attached on the patient's skin. The output and waveform is adjustable according to the situation of patient.
- Device Description:
The Well-Life 4 Channels Multiple Modes Electrical Stimulator/ Model: WL-250A consisted The Well-Life + Chamble Modisle Model Eloctive. The stimulus generator generator generator summer mainly of two parts. the stimulas gonorator, close. The output port transmits the output current oulput current Specificular to the patient's skin so as to transmit this stimulus current to the patient for pain relief or muscle stimulation of intended use purpose.
The Well-Life 4 Channels Multiple Modes Electrical Stimulator/ Model: WL-2504 includes The Well-Life + Channels Modes as mentioned on the comparison table. These its moin several unlerent operation modes as montonou on the microprocessor as its main control unit.
-
- Intended Use:
The indication for use as described hereafter :
- Intended Use:
Transcutaneous Electrical Nerve Stimulator (TENS) & Program can be used for the following applications :
Tonowing upplications intractable pain ---------------------------------------------------------------------------------------------------------------------------------------
Neuromuscular electrical stimulation (NMS) & Program stimulation can be used for the following applications :
1
- Relax muscle spasms
- Prevent or retard disuse atrophy
- · Increase local blood circulation
- · Re-educate muscles
- · Maintain or increase the range of motion
6. Substantial Equivalence Comparison
The WL-2504A has output characteristics and controls that are identical to those of the The WL-2504A has output online of the considered as Substantial Equivalent to the function of chosen 510K chosen predicate devices:
lunction of GRSSH 8 for chools procession is substantial equivalent to WL-2203A (KO33857).
2> The NMS function of WL-2504A is substantial equivalent to WL-2204A (K033857).
2> The Nill Tunction of WL-2504A is substantial equivalent to WL-2204A-P2 (K03387).
4> The IF TENS function of WL-2504A is substantial equivalent to WL-2206D (K092763).
7. Output Performance Range for each Operation Mode
- Current Density Range: Unit mA/cm²..(measured against 500Ω loading at maximum . oulse rate).
| Function | Operation Function | |||
|---|---|---|---|---|
| IF TENS | TENS | EMS | Pre-program | |
| Minimum |