Search Results
Found 22 results
510(k) Data Aggregation
(90 days)
OTC TENS & EMS Unit
The devices of this submission are designed to temporarily relieve muscle soreness and pain in the shoulder, wast, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom caused by exercise or normal household activities. Also used to stimulate healthy muscles to improve muscle performance.
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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for an "OTC TENS & EMS Unit." This document primarily focuses on regulatory approval, substantial equivalence to predicate devices, and general controls and regulations. It does not contain any information about acceptance criteria for device performance, scientific studies, or data related to the device's efficacy or safety.
Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets them from this document. The document explicitly states:
- "We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices."
- "Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading."
- "FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies."
The 510(k) process primarily confirms substantial equivalence to a legally marketed predicate device, not necessarily a de novo clinical study proving performance against specific criteria in the way you've outlined.
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(90 days)
Everyway Analog OTC TENS
Everyway Analog OTC TENS, model N601L is intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
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The provided text is a 510(k) clearance letter from the FDA for a Transcutaneous Electrical Nerve Stimulator (TENS) device. This document does not contain information on the acceptance criteria, study details, or performance metrics of the device as it would typically be presented in a clinical or validation study report.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates that the device was cleared based on its substantial equivalence to a predicate device, rather than through a dedicated study demonstrating performance against specific clinical acceptance criteria.
Therefore, I cannot extract the requested information from the provided text. To answer your questions, I would need access to the full 510(k) submission, device validation reports, or clinical study data if such studies were conducted and included in the submission.
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(645 days)
Avazzia OTC TENS for aesthetics, model BEST-AV1: EZZI-LIFT Device
The Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device is indicated for over-the-counter aesthetic use including facial and neck stimulation or body skin stimulation.
Candidate device is a handheld, AA battery-operated portable device for use in the home or clinic. It has pre-set modes and is for over-the-counter use in the home or a clinical setting. The candidate device uses transcutaneous electrical stimulation (TENS) for aesthetic use for facial, neck, and body stimulation. The EZZI-LIFT device has built-in electrodes. Accessories, listed below, are also available to be used with the device.
The Avazzia OTC TENS for Aesthetics, model BEST-AV1: EZZI-LIFT Device did not have a clinical study that proves the device meets acceptance criteria for a specific clinical outcome. Instead, the device's substantial equivalence was established through non-clinical bench testing, performance testing, and a comparison of its technical characteristics to predicate devices.
Here's the breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal "acceptance criteria" table with specific quantitative thresholds for clinical performance. Instead, it demonstrates substantial equivalence by comparing the technical specifications of the candidate device (EZZI-LIFT) to its predicate devices (NuFACE Trinity and NuBODY Skin Toning Device) and by confirming compliance with relevant safety standards.
The comparison table provided in the document highlights the following characteristics:
| Characteristic | Units | Candidate (EZZI-LIFT) | Primary Predicate (NuFACE Trinity) | Secondary Predicate (NuBody) |
|---|---|---|---|---|
| Device Name | EZZI-LIFT | NuFACE Trinity | NuBody | |
| 510K | K191951 | K181008 | K171588 | |
| Manufacturer | Avazzia, Inc. | Carol Cole Company (dba NuFACE) | Carol Cole Company (dba NuFACE) | |
| Indications for Use | Over-the-counter aesthetic use including facial and neck stimulation or body skin stimulation. | Facial and neck stimulation; over-the-counter cosmetic use. | Body skin stimulation; over-the-counter cosmetic use. | |
| Anatomic Sites | Face, neck, and body | Face and neck | Body | |
| Number of Output Modes | number | 4 | 1 | 1 |
| Low Battery Indicator | Yes | Yes | Yes | |
| Automatic shut off | (minutes) | 60 | 20 | 5 |
| Compliance with Voluntary Standards | Yes/No | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 14971, IEC 62366 | IEC 60601-1, IEC 60601-1-2 | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60529, ISO 14971, IEC 60601-1-6, IEC 62366 |
| Compliance with 21 CFR 898 | Yes / No | Yes | Yes | Yes |
| Weight | ounces | 5.4 | 9 | 10 to 14 |
| Dimensions [W x H x D] | (in.) | 2.6" X 4.7" X 1.35" | 2.8" x 5.1" x 1.3" | 2" x 6.5" x 6.0" |
| Housing Materials and Construction | PCBs inside plastic case housing | Thermoplastic | Thermoplastic | |
| User Interface Display | LEDs and switches | not publicly available | not publicly available | |
| Energy type | Electric stimulation | Electric stimulation | Electric stimulation | |
| Number, Size, and Type of Batteries | Two 1.5 V AA batteries | Internal rechargeable Lithium-ion battery | Internal rechargeable Lithium-ion battery | |
| Stimulation Output Specifications | ||||
| Waveform Shape | positive square wave followed by a damped sinusoidal waveform of variable duration | pulsed biphasic modulated square wave | monophasic voltage modulated square wave | |
| Max output voltage (+/- 20%) at 500 Ω | V | -42 | 28 | 28 |
| Max output voltage (+/- 20%) at 2,000 Ω | V | -122 | not publicly available | not publicly available |
| Max output voltage (+/- 20%) at 10,000 Ω | V | -348 | not publicly available | not publicly available |
| Max output current (+/-20%) at 500 Ω | μA | 363 | 400 | 900 |
| Max output current (+/-20%) at 2,000 Ω | μA | 117 | not publicly available | not publicly available |
| Max output current (+/-20%) at 10,000 Ω | μA | 38 | not publicly available | not publicly available |
| Duration of primary (depolarizing phase) | mSec | 0.5 | 60 | 60 |
| Pulse Duration | mSec | 1.1 | 60 | 60 |
| Frequency | Hz | 15 to 121 | 8.3 | 8.3 |
| Net Charge per pulse at 500 Ω | μC | 4 | not publicly available | 54 |
| Max phase charge | μC | 10 | not publicly available | not publicly available |
| Max current density at 500 Ω (Built-in, Y, Brush) | μΑ/cm² | 800 | 419 | 468 |
| Max current density at 500 Ω (Pencil) | μΑ/cm² | 19,000 | ||
| Max average power density at 500 Ω (Built-in, Y, Brush) | μW/cm² | 500 | not publicly available | 4,180 |
| Max average power density at 500 Ω (Pencil) | μW/cm² | 3,500 | ||
| Burst mode (a) pulse per burst | number | 1 | 20 | 20 |
| Burst mode (b) burst per second | number | n/a | 8.3 | 8.3 |
| Burst mode (c) burst duration | (sec) | n/a | 2.4 | 2.4 |
| Burst mode (d) duty cycle | n/a | 20.2sec | 20.2sec | |
| On Time (per second) | seconds | 0.1 | not publicly available | not publicly available |
| Off Time (per second) | seconds | 0.9 | not publicly available | not publicly available |
| Electrodes (a) materials | Stainless steel 316 | Chrome-plated | Chrome-plated | |
| (b) electroconductive media | n/a | Conductive gel | Conductive gel | |
| (c) electrode-to-skin impedance range | less than 15 | not publicly available | not publicly available | |
| (d) max duration of use (same as device shut off) | (minutes) | 60 | 20 | 20 |
| (e) conductive surface area (built in rectangular) | cm2 | 1.94 | - | - |
| (e) conductive surface area (spherical) | cm2 | 5.60 | not publicly available | not publicly available |
| (e) conductive surface area (brush/comb) | cm2 | 0.56 | not publicly available | not publicly available |
| (e) conductive surface area (small circular, pencil-like) | cm2 | 0.023 | not publicly available | not publicly available |
The acceptance criterion, though not explicitly stated as a pass/fail threshold, is implied to be that the device's technical characteristics, particularly regarding stimulation output and safety features, fall within the range of equivalence to predicate devices and comply with accepted safety standards (e.g., ANSI/AAMI NS4:2013/(R)2017). The document explicitly states: "The candidate devices fall within the same range of equivalence for performance and energy output for meeting the ANSI/AAMI NS4:2013/(R)2017 standard requirements for safety; and therefore, they do not raise new questions of safety."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes non-clinical bench testing and usability studies, not traditional clinical trials with patient test sets. Therefore, terms like "sample size for the test set" (in a clinical context) and "data provenance" (country of origin, retrospective/prospective) are not directly applicable.
- Test Set (Non-clinical): The "test set" for performance testing consisted of "a production equivalent of the candidate device." The specific number of devices tested is not mentioned.
- Usability Study: A usability study was performed, but the number of participants or their demographics are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the clearance was based on substantial equivalence to predicate devices and non-clinical testing, rather than a study requiring expert consensus on clinical ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the clearance was based on non-clinical testing and comparison to predicate devices, which do not involve adjudication by multiple experts on a clinical test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There was no MRMC comparative effectiveness study done. This device is a Transcutaneous Electrical Nerve Stimulator (TENS) for aesthetic use, not an AI-assisted diagnostic or imaging device that would typically involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable as the device is not an algorithm or AI-based system. It's a hardware device (TENS stimulator). Its "standalone performance" refers to its electrical output, safety, and functionality as evaluated in non-clinical bench tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this type of device and submission, the "ground truth" is primarily established by compliance with recognized electrical and medical device safety standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 14971, IEC 62366, ANSI/AAMI NS4:2013/(R)2017) and the established safety and effectiveness of the legally marketed predicate devices for their intended uses. The document states that "The Avazzia device technological specifications are similar; therefore, they do not pose new questions regarding safety and effectiveness." The usability study also confirmed that the device and instructions "met requirements for usability factors for over-the-counter use."
8. The sample size for the training set
This information is not applicable as the device is a hardware TENS stimulator and does not involve AI/machine learning models with training sets.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this device.
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(85 days)
Everyway Analog OTC TENS, model N103A/N302
Everyway Analog OTC TENS, model N103A/N302 is intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
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The provided text is a 510(k) clearance letter from the FDA for a medical device called "Everyway Analog OTC TENS, model N103A/N302." This document primarily focuses on the regulatory clearance process and does not contain information regarding the acceptance criteria, specific performance study details, or ground truth establishment for a medical device's AI or standalone performance.
Therefore, I cannot fulfill your request for the detailed information outlined in points 1-9 based on the provided text. The document confirms that the device is a Transcutaneous Electrical Nerve Stimulator For Pain Relief and is cleared for Over-The-Counter Use for temporary relief of pain associated with sore and aching muscles. However, it does not describe the technical performance evaluation or clinical study results that would typically be associated with AI or standalone device performance testing.
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(89 days)
Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300
TENS (For model EM-6000, EM-6100 & EM-6300) : intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. (Choose TENS B/N/M/S1/S2 adjustable mode & TENS Modes P to P6 for EM-6300).
EMS (For model EM-6000, EM-6200 & EM-6300): intended to stimulate healthy muscles in order to improve or facilitate muscle performance. (Choose EMS C/S/A adjustable mode & EMS Modes P7 to P12 for EM-6300).
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I am sorry, but the provided text does not contain any information about acceptance criteria for a medical device or a study proving that a device meets those criteria. The document is a 510(k) clearance letter from the FDA for a TENS/EMS device, confirming its substantial equivalence to a predicate device. It discusses regulatory compliance and indications for use but does not detail performance acceptance criteria or specific study results to demonstrate those criteria are met.
Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, or training set details.
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(88 days)
Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806
TENS: intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. (For EV-806: Choose TENS Modes B/N/M/SD1/SD2 adjustable mode).
EMS: intended to stimulate healthy muscles in order to improve or facilitate muscle performance. (For EV-806 : Choose EMS Modes C/S/A adjustable mode)
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The provided text is a 510(k) premarket notification letter from the FDA regarding a Transcutaneous Electrical Nerve Stimulator (TENS)/Electrical Muscle Stimulator (EMS) device. It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, the provided document does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria. The letter focuses on the regulatory clearance process and substantial equivalence, not on the technical performance evaluation of the device in the context of specific performance metrics or clinical study results.
Therefore, I cannot provide details for the following points based on the given input:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi-reader, multi-case (MRMC) comparative effectiveness study was done
- If a standalone (algorithm only without human-in-the-loop performance) study was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
The letter indicates that the device is intended for "temporary relief of pain associated with sore and aching muscles" (TENS) and "to stimulate healthy muscles in order to improve or facilitate muscle performance" (EMS). While these are the intended uses, there are no performance metrics or study details within this document to evaluate how well the device achieves these indications.
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(157 days)
Li-Battery powered OTC TENS/EMS Combination Stimulator
TENS: intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. (Choose TENS Modes B/N/M/SD1/SD2 as adjustable mode and P1 to P12 preset programs only for EV-906A).
EMS: intended to stimulate healthy muscles in order to improve or facilitate muscle performance. (Choose EMS Modes C/S/A as adjustable mode and P13 to P24 preset programs only for EV-906A).
Li-Battery powered OTC TENS/EMS Combination Stimulator, models EV-906/EV-906A.
I am sorry, but the provided text is a 510(k) clearance letter for a medical device and does not contain the detailed information about acceptance criteria, study design, or performance metrics that you are requesting. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.
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(134 days)
Tyece OTC TENS Model
The Tyece OTC TENS Device EM26 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the shoulder and neck due to strain from exercise or normal household and work activities.
The Tyece OTC TENS Device EM27 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the lower extremities (leg) due to strain from exercise or normal household and work activities.
The Tyece OTC TENS Device EM28 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the upper extremities (arm) due to strain from exercise or normal household and work activities.
The Tyece OTC TENS Device EM29 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household and work activities.
The Tyece OTC TENS Device EM26, EM27, EM28 and EM29 powered by 4.5V (3 x 1.5V AAA /Alkaline batteries), is similar to the predicate device, LT3060 (K130802), with the following features:
a. It is a portable single-channel, battery operated Transcutaneous Electrical Nerve Stimulator stimulation system. The predicate is a dual-channel TENS device.
b. It contains 4 programs, similar to the predicate device which has 12 programs
c. The output strength is adjustable from 0-110mA, similar to the predicate device at 0-96mA, via regulated voltage.
d. The LCD display is provided for the indication of operation status including operation mode, output program mode, output intensity, time to cut-off, and battery low indication.
The provided document is a 510(k) Premarket Notification from the FDA regarding the Tyece OTC TENS Devices (Models EM26, EM27, EM28, and EM29). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through novel studies.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria, as it relates to a typical AI/ML device submission's performance evaluation.
Specifically, it lacks data on:
- A table of acceptance criteria and reported device performance: The document compares technical specifications of the Tyece TENS devices to a predicate device, but this is not an "acceptance criteria" table in the context of an AI/ML device's performance (e.g., sensitivity, specificity, AUC).
- Sample size and data provenance for a test set: No specific test set for evaluating AI/ML algorithm performance is mentioned.
- Number and qualifications of experts for ground truth: Not applicable, as there's no AI/ML algorithm requiring expert ground truth for interpretation.
- Adjudication method: Not applicable.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not conducted. The TENS device is a physical product, not an AI.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth: Not applicable.
- Sample size for training set: Not applicable.
- How ground truth for training set was established: Not applicable.
Instead, the document details the technical comparisons of the Tyece TENS devices to a predicate TENS device (LT3060, K130802) and a reference device (Savia OTC TENS Model EM-38, K113321). The "study" mentioned here refers to non-clinical testing performed to validate design conformance with voluntary standards (e.g., IEC 60601 series for electrical safety and electromagnetic compatibility) and software validation. These tests are intended to demonstrate that the Tyece devices maintain the same safety and effectiveness as the predicate device despite some differences in specifications (e.g., single vs. dual channel, different battery types, output parameters). The "discussion of differences" in the tables explains why these differences do not adversely impact safety and effectiveness, leading to the conclusion of substantial equivalence.
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(90 days)
Everyway OTC TENS/EMS Combination
TENS: intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. (Choose TENS Modes B/N/M/SD1/SD2 as adjustable mode and P1 to P12 preset programs only for EV-906A).
EMS: intended to stimulate healthy muscles in order to improve or facilitate muscle performance. (Choose EMS Modes C/S/A as adjustable mode and P13 to P24 preset programs only for EV-906A).
Not Found
The provided text is a 510(k) clearance letter from the FDA for a medical device (EV-906 & EV-906A OTC TENS/EMS Combination). This type of document is administrative and confirms that the device is substantially equivalent to a legally marketed predicate device.
It does not contain information about:
- Acceptance criteria and reported device performance related to a study. The letter states that the 510(k) submission was not re-reviewed for the administrative correction, and the original letter from Dec 19, 2019, simply states that the FDA "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent." This determination is based on a comparison to a predicate device, not on clinical performance acceptance criteria or a study proving performance against such criteria.
- Sample size, data provenance, expert numbers, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth methods. These are details typically found in a clinical study report or a summary of safety and effectiveness, which are not part of a 510(k) clearance letter.
Therefore, I cannot fulfill your request using the provided input. The document confirms the regulatory clearance of a Transcutaneous Electrical Nerve Stimulator (TENS) and Electrical Muscle Stimulator (EMS) device as substantially equivalent to a predicate, but it does not detail the specific performance studies, acceptance criteria, or methodology that your questions pertain to.
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(123 days)
GIM-STIM OTC TENS/EMS System
GM511TE & GM511T- for temporary relief of pain associated with sore and aching muscles in the lower back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 to P9 or P17 to P19 and C/B/M/H1/H2 adjustable mode)
GM511TE & GM511T- for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis). It is also used as an adjunctive treatment for post-surgical and post-traumatic acute pain. (Choose TENS Mode P10)
GM511TE & GM511E - for use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. (Choose EMS Modes P11 to P16 and C/S/A adjustable mode)
GM510TE & GM510T- for temporary relief of pain associated with sore and aching muscles in the lower back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 to P9 or P17 to P19)
GM510TE & GM510T- for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis). It is also used as an adjunctive treatment for post-surgical and post-traumatic acute pain. (Choose TENS Mode P10)
GM510TE & GM510E - for use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. (Choose EMS Modes P11 to P16)
GM520TE & GM520T- for temporary relief of pain associated with sore and aching muscles in the lower back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 to P9 or P17 to P19)
GM520TE & GM520T- for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis). It is also used as an adjunctive treatment for post-surgical and post-traumatic acute pain. (Choose TENS Mode P10 )
GM520TE & GM520E - for use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. (Choose EMS Modes P11 to P16)
GM530TE & GM530T- for temporary relief of pain associated with sore and aching muscles in the lower back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 to P9 or P17 to P19)
GM530TE & GM530T- for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis). It is also used as an adjunctive treatment for post-surgical and post-traumatic acute pain. (Choose TENS Mode P10)
GM530TE & GM530E - for use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. (Choose EMS Modes P11 to P16)
GM540TE & GM540T- for temporary relief of pain associated with sore and aching muscles in the lower back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 to P9 or P17 to P19)
GM540TE & GM540T- for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis). It is also used as an adjunctive treatment for post-surgical and post-traumatic acute pain. (Choose TENS Mode P10)
GM540TE & GM540E - for use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. (ChooseEMS Modes P11 to P16)
Not Found
This document is a 510(k) premarket notification clearance letter from the FDA for the GEM-STIM OTC TENS/EMS System. It does not contain information about acceptance criteria or studies proving device performance. The letter primarily states that the FDA has reviewed the submission and determined that the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies from the provided text. This type of detailed performance data is typically found in the actual 510(k) submission, not in the clearance letter itself.
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