Search Results

SM9009:
TENS(1-7,9,10,14,16,19,21,22,24):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
PMS(8,11,12,13,15,17,18,20,23):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

SM9021:
TENS(3-6,8-11,15,16,19,21):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
PMS(1,2,7,12,13,14,17,18,20,22,23,24):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

SM9128H:
TENS(2-6,9,11,14,16,19,21,22,24):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
PMS(1,7,8,10,12,13,15,17,18,20,23):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

SM9015:
TENS(2-4.8.9.10.12.13.14.15.17.18.19.20.22):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
PMS(1.5,6.7,11,16,21,23,24):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

SM9055:
TENS(1-8,10,11,13,14,16,19,21-25,30,31,35,36):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
PMS(9,12,15,17,18,20,26,27,28,29,32,33,34):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

SM9033:
TENS(1-16,19,21,22):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
PMS(17,18,20,23,24):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Not Found

The provided text is a 510(k) premarket notification document from the FDA for TENS & PMS devices. It outlines the regulatory clearance process and includes "Indications for Use" for several models. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert reviews for a medical device.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to predicate devices, not on detailed performance study results of the new device.

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SM9089:
TENS(3,4,5,6,8,15,19,21):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
PMS(1,2,7,9,10,11,12,13,14,16,17,18,20,22,23,24):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

SM9587:
TENS(3.4.5.6 8.11.15.16.19.21.22):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
PMS(1,2,7,9,10,12,13,14,17,18,20,23,24):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

SM9592:
TENS(2,3,4,5,7,9,10,19,21,22,24):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
PMS(1,6,8,11,12,13,14,15,16,17,18,20,23):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

SM9555:
TENS(3-6, 13,14,19-21,23):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
PMS(1,2,7-12,15-18,22,24):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Not Found

The provided document is an FDA 510(k) clearance letter for Transcutaneous Electrical Nerve Stimulators (TENS) and Powered Muscle Stimulators (PMS) devices. It confirms that the devices are substantially equivalent to legally marketed predicate devices.

However, this document does not contain information about the acceptance criteria or a study that proves the device meets specific acceptance criteria. The letter primarily addresses regulatory clearance based on substantial equivalence to existing devices, general controls provisions of the Federal Food, Drug, and Cosmetic Act, and specifies the Indications for Use for various models.

For a device's performance to be evaluated against acceptance criteria, a clinical study or performance testing data would typically be required to be referenced in the submission. This information is usually found in the 510(k) summary or the detailed technical documentation submitted to the FDA, which is not part of this public clearance letter.

Therefore, I cannot provide the requested details using only the provided text. The document is a regulatory approval, not a performance study report.

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TENS (3-6, 13, 14, 20, 21, 23): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. PMS (1, 2, 7-12, 15-19, 22, 24): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Not Found

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a TENS & PMS device. It details the regulatory clearance for the device but does not include any study data, acceptance criteria, or information regarding performance testing, sample sizes, ground truth establishment, or expert involvement in product validation.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or any of the other requested details about a study proving the device meets those criteria.

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TENS(1,3,4,5,6,21): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
PMS(2,7,8,9,10,11,12,13,14,15,16,17,18,19,20,22,23,24): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Model: SM9126
TENS(3,4,5,6,11,12,16): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
PMS(1,2,7,8,9,10,13,14,15): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Model: SM9186
TENS(3,4,7,8,11): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
PMS(1,2,5,6,9,10,12): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Model: SM9196
TENS(1015): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
PMS(19): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

TENS & PMS is a portable and DC 3.7V battery powered multifunction device with multiple models, offering both Transcutaneous Electrical Nerve Stimulation (TENS) and Powered Muscle Stimulation (PMS) qualities in one device. The device is equipped with accessories of electrode pads, electrode cables, a battery charger, and one USB cable. The electrode cables are used to connect the pads to the device; the USB cable is used to connect the charger and the built-in lithium battery. All accessories, including USB cables, electrode pads, electrode cables, chargers can only be changed or replaced by a qualified person.

The provided text describes a 510(k) premarket notification for a TENS & PMS device. This submission aims to demonstrate substantial equivalence to an already legally marketed predicate device (K121719). The document focuses on comparing the technical characteristics and performance of the new device models (SM9079, SM9126, SM9186, SM9196) against the predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are implicitly defined by the safety and performance parameters of the legally marketed predicate device (K121719) and compliance with various recognized standards. The reported device performance is demonstrated through the comparative tables (Table 1, 2, 3, 4) where the new device's parameters are listed alongside the predicate device's, and through the statement of compliance with specific IEC and ANSI/AAMI standards.

Since the tables in the document are already in a comparative format, I will summarize the key parameters and their reported performance for one of the new models (SM9079) against the predicate. The "Remark" column in the original tables already serves as a concise statement of whether the new device meets or is similar to the predicate.

Table: Acceptance Criteria and Reported Device Performance (Example: Model SM9079 vs. Predicate K121719)

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Model SM9187:

TENS (Mode 1, 3, 4, 5, 6):

To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. PMS (Mode 1, 2, 3, 4, 5, 6):

It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Model SM9180L & SM9180S:

TENS (Mode 1. 3. 4. 5. 6):

To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, back due to strain from exercise or normal household work activities.

PMS (Mode 1, 2, 3, 4, 5, 6):

It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Sunmas TENS & PMS (Model SM9187, SM9180L & SM9180S) is a portable battery powered device with a wireless feature for over-the-counter use, offering both Transcutaneous Electrical Nerve Stimulation (TENS) and Powered Muscle Stimulation (PMS) qualities in one device. Sunmas TENS & PMS has totally 6 modes, applying electrical current to electrodes on a patient's skin to relieve pain or build up muscle. Due to different electrode shapes and sizes, Model SM9187 can be used on the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (legs), while Model SM9180L and SM9180S can be used on the shoulder, back and abdomen. Model SM9187 is designed to be controlled by a mobile phone application program (APP) named “Dr.Stim”, through Bluetooth 4.0 technology (Frequency: 2402.0 - 2480.0MHz). The APP is developed by Hong Qiangxing (Shenzhen) electronics Limited. SM9187 consists of a round main unit, two sets of self-adhesive electrode pad, a mobile application (APP), an AC charger and a USB cable. Model SM9180L and SM9180S both have a butterfly-shaped main unit (Frequency: 2450MHz) and can be remotely controlled through wireless technology. SM9180L has a black remote control with an electronic display screen which is powered by two AAA alkaline batteries, while Model SM9180S has a white remote control powered by a CR2032 coin battery. The radio frequency of remote control (both black and white) is 2405.0 - 2470.0MHz. Model SM9180L and SM9180S consists of a unit, two pairs of electrode gels, a remote control (black or white), an AC charger and a USB cable.

This document is a 510(k) Pre-Market Notification for a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) device. The purpose of this notification is to demonstrate that the new device, Sunmas TENS & PMS (Models SM9187, SM9180L, SM9180S), is substantially equivalent to legally marketed predicate devices.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies, as requested:

1. A table of acceptance criteria and the reported device performance

The provided document doesn't explicitly present a table of "acceptance criteria" in the sense of predefined performance thresholds for a clinical study. Instead, it compares the technical specifications and safety standards compliance of the new device with those of its predicate devices to demonstrate substantial equivalence. The implicit "acceptance criteria" are that the new device's specifications and safety performance are comparable to or meet the standards of the predicate devices.

Below is a table summarizing key comparative performance metrics, drawn directly from the "Substantial Equivalence to Predicate device" tables (Table 1 and Table 2) within the document. The "Reported Device Performance" for the new device is its own specifications, and the "Acceptance Criteria" are implied by the predicate device's specifications and the statement that the new device is "safe and effective as the predicate devices cited above."

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SM Electrodes are intended to transmit electrical current to patient skin for use with transcutaneous electrical stimulation devices. Some common types of the stimulation devices include, but are not limit to TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The electrode is for OTC (Over-The -Counter) or Prescription use.

SM Electrode pad is used as an accessory to the TENS or EMS device unit, which transmits electrical current to patient skin. The electrical current of electrode pad is first transmitted via the snap button then transmitted to the conductive gel which is adhered to patient skin.

SM Electrode Pad is composed of a top cover material, connector snap button, conductive carbon film, conductive hydrogel media, and a carrier line.

It is non-sterile and intended for single adult patient multiple application use. The SM Electrode has various shapes and sizes.

To connect with a nerve or muscle stimulator, this SM Electrode Pad has male snap button. The electrical pad connecting two separated gels together through a non-woven fabric has a pair of male snap button and the diameter is 3mm. The electrical pad with only one male snap button are to be used in pairs and the diameter of snap button is 4mm.

When not in use, the hydrogel face is covered by a PET(polyethylene terephthalate) carrier line.

The provided text describes the submission for K183154, "SM Electrodes," a cutaneous electrode. It details non-clinical testing performed to establish substantial equivalence to predicate devices.

Here's the information broken down as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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 does not explicitly state the sample sizes used for each specific bench test (e.g., how many electrodes were tested for impedance, adhesion, or biocompatibility). It only states that "Bench tests were conducted on SM Electrodes."

The data provenance is from non-clinical bench tests. The location where these tests were conducted is not specified, but the manufacturer is Hong Qiangxing (Shen Zhen) Electronics Limited in Guangdong, China.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This submission relies solely on non-clinical bench testing against established international and national standards, not on expert-driven ground truth for clinical performance. The "ground truth" here is the adherence to the defined parameters and limits within those standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There was no clinical study with a test set requiring adjudication. The assessment was based on objective measurements against engineering and biocompatibility standards.

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

No MRMC comparative effectiveness study was performed or included in this submission. The device is a cutaneous electrode, an accessory for stimulation devices, and does not involve AI or human "readers" in the context of image interpretation or diagnostic tasks.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device is a physical cutaneous electrode, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the non-clinical tests was established by recognized international and national standards. Compliance with these standards (ASTM, ISO, ANSI AAMI IEC) served as the basis for determining the device's acceptable performance and safety characteristics.

8. The sample size for the training set

Not applicable. This device is a physical medical device, not an AI/ML algorithm. There is no concept of a "training set" in this context.

9. How the ground truth for the training set was established

Not applicable. As there is no training set for an AI/ML algorithm, no ground truth needed to be established for it.

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TENS: To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. PMS: It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

SM TENS & PMS is a portable and DC 3.7V battery powered multi function device, offering both Transcutancous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) qualities in one device. SM TENS & PMS has 6 operation modes, which can give certain electrical pulses through electrode adhesive pads to the suggested area of the body where the electrodes are placed. The electronic stimulatory module has the operating elements of ON/OFF Switch, Display screen, Mode Selection key, Intensity Modification keys, Timing key, Pause key, Output socket, and USB port for battery charging. The display screen can show battery power, selected mode, current intensity, time remaining of an application mode, and indication of a pause. The device is equipped with accessories of electrode pads, electrode cables, battery chargers, and USB cables. The electrode cables are used to connect the pads to the device; the USB cable is used to connect the charger and the built-in lithium battery. All accessories, including USB cables, electrode pads, electrode cables, chargers can only be changed by special person. The electrodes are interchangeable. The application area of electrode pads must be larger than 4cm². The electrode pads are provided by GMDASZ Manufacturing Co., Ltd. with 510(k) cleared Number K092546.

This submission is for a Traditional 510(k) for a new device, the "SM TENS & PMS" from Hong Qiangxing (Shen Zhen) Electronics Limited. The device is a portable, battery-powered multi-function device offering both Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) functionalities. The 510(k) submission seeks to demonstrate substantial equivalence to a predicate device, the "Powered Muscle Stimulator, JQ-5C" (K102598).

The acceptance criteria are established through a comparison of the new device's technical characteristics and performance against the predicate device and relevant safety standards. The study proving the device meets the acceptance criteria is a safety testing protocol, which demonstrates compliance with recognized electrical and medical device standards.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria, for the purpose of a 510(k) for substantial equivalence, are primarily that the new device performs equivalently to the predicate device in its intended use and meets relevant safety standards, without raising new questions of safety or effectiveness. The reported device performance is based on the results of the safety testing.

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