(333 days)
No
The description details a standard TENS/PMS device with pre-set modes and manual controls, with no mention of adaptive algorithms, learning capabilities, or AI/ML terminology.
Yes
The device is used for temporary pain relief and to improve muscle performance, which are therapeutic purposes.
No
The device description clearly states its purpose is for "temporary relief of pain" and to "stimulate healthy muscles in order to improve and facilitate muscle performance," which are therapeutic functions, not diagnostic ones.
No
The device description explicitly states it is a "portable and DC 3.7V battery powered multi function device" with physical components like a display screen, keys, output socket, and USB port, and includes accessories like electrode pads and cables. 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: The intended use clearly states the device is for temporary pain relief and muscle stimulation on the body (shoulder, waist, back, neck, arms, legs). This is a therapeutic use, not a diagnostic one.
- Device Description: The description details a device that delivers electrical pulses through electrodes applied to the skin. This is consistent with a TENS/PMS device used for physical therapy or pain management, not for analyzing samples from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
In summary, the device's function and intended use are entirely focused on external application to the body for therapeutic purposes, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NUH, NGX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg)
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
l long Qiangxing (Shen Zhen) Electronics Limited 4F. Jingcheng Building. Xicheng Industrial Zone. Xixiang Road. Bao an District. Shenzhen. Guangdong. China
Tcl: 86-755 26423605 / Url: www.sunmas.hk
Section 5 510(k) Summary [As required by 21 CFR 807.92]
- Submission Information:
Type of 510(k) Submission:
Basis for 510(k) Submission:
Submitter/Manufacturer:
510(k) Number:
Date:
Contactor:
·K121719 October 23td, 2012 Traditional New device Hong Qiangxing (Shen Zhen) Electronics Limited 4F, Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'an District, Shenzhen City, Guangdong, China 518126 Doris Dong [Consultant, from Shanghai CV Technology Co., Ltd.] Add .: Room 1706 Yuesha, No. 128 Songle Rd., Songjiang, Shanghai, China 201600 E-mail: doris_d@l26.com Tel: 86 21-31261348 Fax: 86 21-37824346
- Device Description: Proprietary Name: Common Name: . Classification Name:
Regulation Number: Product Code: Device Class: Review Panel: Device Description:
TENS & PMS Stimulator, nerve, transcutaneous, over-the-counter, Stimulator, muscle, powered, for muscle conditioning 882.5890. 890.5850 NUH, NGX II
Neurology & Physical Medicine
SM TENS & PMS
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
MAY 1 0 2013
1
Hong Qiangxing (Shen Zhen) Electronics Limited
Hong Qiangxing (Shen Zhen) Electronics Limited
4ti, Jingsteng Building, Xicheng Industrial Zone, Xixiang Road, Bao' an District, Shenzhen, Ghangdong. China
Tel: 86-755 264
| Indications for use: | 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.
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 |
| ---------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
3. Substantial Equivalence to Predicate device:
Detailed comparison data is included in "Section 9 - Substantial Equivalence Discussion" of this 510(k) submission. .
and facilitate muscle performance.
| Parameters | New Device | Predicate Device | |
|---|---|---|---|
| 1. | 510(k) Number | K121719 | K102598 |
| 2. | Marketing clearance date: | - | May 13, 2011 |
| 3. | Device Name | SM TENS & PMS | Powered Muscle Stimulator, JQ-SC |
| 4. | Manufacturer | Hong Qiangxing (Shenzhen) Electronics | |
| Limited | Hi-Dow International, Inc. | ||
| 5. | Accessories | Self-adhesive electrodes, electrode wires. | Self-adhesive electrodes, electrode wires, |
| Battery charger, USB cable. | Battery charger, USB cable | ||
| 6. | Intended use | TENS (Mode 1, 3, 4, 5, 6): | TENS (Mode 1. 3. 4. 5. 6): |
| To be used for temporary relief of pain | To be used for temporary relief of pain | ||
| associated with sore and aching muscles in | associated with sore and aching muscles | ||
| the shoulder, waist, back, neck, upper | in the shoulder, waist, back, neck, upper | ||
| extremities (arm), and lower extremities | extremities (arm), and lower extremities | ||
| (leg) due to strain from exercise or normal | (leg) due to strain from exercise or | ||
| household work activities. | normal household work activities. | ||
| PMS (Mode 1, 2, 3, 6): | PMS (Mode 1, 2, 3, 6): | ||
| It is intended to be used to stimulate healthy | It is intended to be used to stimulate | ||
| muscles in order to improve and facilitate | healthy muscles in order to improve and | ||
| muscle performance. | facilitate muscle performance. | ||
| 7. | Power Source(s) | DC 3.7V lithium battery | DC 3.7V lithium battery |
| - Method of Line Current | Type BF | Type BF | |
| Isolation | |||
| - Patient Leakage Current | - | - | |
| - Normal Condition | 2μA | 2μA | |
| - Single Fault |