(150 days)
No
The device description and performance studies focus on standard electrical stimulation technology and safety/performance testing, with no mention of AI or ML capabilities.
Yes
Explanation: The device is explicitly described as providing "non-pharmacological pain relief and improve muscle performance and recovery" through TENS and EMS, thus making it a therapeutic device.
No
Explanation: The device description and intended use clearly state that the "Wireless Electrical Stimulator" is designed for pain relief through Transcutaneous Electrical Nerve Stimulation (TENS) and Electrical Muscular Stimulation (EMS) to improve muscle performance and recovery. It does not mention any function for diagnosing conditions or diseases.
No
The device description clearly states it includes hardware components such as a remote control, stimulator pod(s), batteries, a screen, buttons, electrodes, and a charging cable. It is a physical electrical stimulator device controlled by a remote.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for temporary relief of pain and to stimulate muscles. These are therapeutic applications, not diagnostic ones.
- Device Description: The description details a wireless electrical stimulator that applies electrical currents to the body. This is consistent with TENS and EMS devices, which are used for physical therapy and pain management.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status or condition based on such analysis. IVD devices are specifically designed for these purposes.
Therefore, this device falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
TENS:
[RS-18, RS-28, RS-38 models]: 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.
[RS-18, RS-38 models]: For temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medications.
[RS-18, RS-28 models]: It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
EMS:
[RS-18, RS-28 models]: 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, NYN
Device Description
"Wireless Electrical Stimulator" is a battery-powered wireless electrical stimulator designed and intended to provide Transcutaneous Electrical Nerve Stimulation (TENS) and Electrical Muscular Stimulation (EMS) for the use of non-pharmacological pain relief and improve muscle performance and recovery.
The "Wireless Electrical Stimulator" includes a remote control, stimulator pod(s) and several accessories. Both the remote control and the stimulator pod are powered by a 3.7V lithium-ion polymer battery. The remote control has a 1.77" TFT LCD screen and 4 buttons to control multiple stimulator pod(s) at the same time. Each stimulator pod has two output channels, and will perform electrical stimulation according to the parameter settings sent by the remote control. The stimulator pods can also be used independently via its own 3 buttons based on preset parameter.
The accessories include self-adhesive electrodes, kneelelbow brace, and the USB Type-C charging cable. The adhesive electrodes for "Wireless Electrical Stimulator" are connected with the Stimulator Pod(s) via magnetic snap and lead wire. There are replaceable hydrogel pads on the self-adhesive electrode pads. Users can replace the hydrogel when it exceeds its useful life, but does not need to discard the entire electrode. To apply electrical stimulation to body joints (e.g. knees and elbows), users can easily place electrodes on specific body parts using the Knee/elbow brace. The remote control and stimulator pods are the same for all models. The 3 models have different accessories to match their specific usage instructions. Below are the accessory variants for each model.
Product Name | Wireless TENS/EMS | Brace TENS/EMS | Menstrual Pain Relief TENS |
---|---|---|---|
Model | RS-18 | RS-28 | RS-38 |
Indication of Use | General TENS/EMS | TENS/EMS for joint (knee & elbow) | TENS for period pain (dysmenorrhea) |
Adhesive Electrodes | ● | ● | ● |
Electrode Lead Wire | ● | ● | ● |
Knee/Elbow Brace | n/a | ● | n/a |
USB Type C Charge Cable | • | • | • |
Besides the accessory variants, the programs of all models also have some variants depend on the indication. RS-18 model has a "General TENS/EMS" indication, it includes all therapy programs. RS-28 model is indicated for "TENS/EMS for joint (knee & elbow)" and the RS-38 model is indicated for "TENS for period pain (dysmenorrhea)." Following are the program variants for each models.
Therapy Type | Program | RS-18 | RS-28 | RS-38 |
---|---|---|---|---|
Pain Relief | Acute Pain | ● | ● | ● |
Chronic Pain | ● | ● | ● | |
Soreness | ● | ● | ● | |
Pain Relief | Back Pain | ● | n/a | ● |
Menstrual Cramping | ● | n/a | ● | |
Pain Relief | Arthritis | ● | ● | n/a |
Training | Warm-up | ● | ● | n/a |
Recovery | ● | ● | n/a | |
Atrophy | ● | ● | n/a | |
Strength | ● | ● | n/a | |
Endurance | ● | ● | n/a | |
Massage | Resistance | ● | ● | n/a |
Comfort | ● | ● | ● | |
Kneading | ● | ● | ● | |
Tapping | ● | ● | ● | |
Relaxation | ● | ● | ● | |
Tingling | ● | ● | ● | |
Alternating | ● | ● | ● |
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) for temporary relief of pain associated with sore and aching muscles; dysmenorrhea (menstrual cramps); muscles (for stimulation to improve and facilitate muscle performance)
Indicated Patient Age Range
Adult
Intended User / Care Setting
Clinics, hospital and home environments (over-the-counter)
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)
Non-clinical Testing:
Biocompatibility testing: "Wireless Electrical Stimulator" was evaluated per ISO 10993-1, ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization & Irritation).
Electrical safety and electromagnetic compatibility (EMC): Complies with IEC 60601-1, IEC 60601-1-11, IEC 60601-2-10, and IEC 60601-1-2. Stimulation function tests were also conducted.
Software Verification and Validation Testing: Considered "Moderate" level of concern.
Human Factor and Usability Testing: Conducted per IEC 62366-1. Result: no critical errors, performance can be smoother with extra practices. Device found reasonably safe and effective.
Performance Bench Testing (Devices): Function performance tests proved Remote Control and Stimulator (Receiver) Pod are safe and effective.
Performance Bench Testing (Electrode): AC Impedance, Current Dispersion, Retention Force Test, and Reusability Test proved the Self-Adhesive Electrode is identical to or better than the Reference Device, indicating safety and effectiveness.
Mechanical and Stability Testing: Button reliability, lead wire connector/bending life, drop/vibration, temperature/humidity cycle, and device life tests conducted. Result: device works well throughout service life, safe and effective.
Clinical Studies:
Not applicable. Clinical testing was not performed to support this 510(k) submission.
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
Not Found
§ 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
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" being larger and bolder than the rest of the text.
September 1, 2022
ZMI Electronics Ltd. Yuta Lee President 6F-1, 286-4, Shin Ya Road Kaohsiung, R.O.C. 806 Taiwan
Re: K220997
Trade/Device Name: Wireless TENS/EMS, Bruno, Aela Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH, NGX, NYN Dated: July 29, 2022 Received: August 2, 2022
Dear Yuta Lee:
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 marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that 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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Pamela Scott Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220997
Device Name
Wireless Electrical Stimulator (Models RS-18, RS-28, RS-38)
Indications for Use (Describe)
TENS:
[RS-18, RS-28, RS-38 models]: 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.
[RS-18, RS-38 models]: For temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medications.
[RS-18, RS-28 models]: It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
EMS:
[RS-18, RS-28 models]: To stimulate healthy muscles in order to improve and facilitate muscle performance.
Environments of Use: Clinics, hospital and home environments (over-the-counter) Patient Population: Adult
Type of Use (Select one or both, as applicable) | |
---|---|
Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
1. Submitter Information
Applicant Name: ZMI Electronics Ltd. Address: 6F-1, 286-4, Shin-Ya Road, Kaohsiung, Taiwan 806 Phone: +886-7-8150053 Fax: +886-7-8150057 E-mail: mail@zmi-electronics.com
Contact Person
Name: Lawrence Liu Title: Regulatory Affairs Manager Phone: +886-7-8150053 Ext 351 Fax: +886-7-8150057 E-mail: lawrence@zmi-electronics.com
Date Summary Prepared: February 10, 2022
2. Device Information
Device Name: Wireless Electrical Stimulator Model: RS-18, RS-28, RS-38 Regulation Number: 21 CFR 882.5890 Classification Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH Subsequent Product Code: NGX, NYN
3. Predicate device
Primary Predicate
510K Number: K161453 Device Name: Well Life Wireless TENS/EMS Stimulator, Models WR-2605A/2605 Regulation Number: 21 CFR 882.5890 Classification Name: Transcutaneous electrical nerve stimulator for pain relief Requlatory Class: Class II Product Code: NUH Subsequent Product Code: NGX, NYN
Secondary Predicate
510K Number: K183215 Device Name: Focus TENS Therapy, Model PM710-M/-L Requlation Number: 21 CFR 882.5890
Classification Name: Transcutaneous electrical nerve stimulator for pain relief
4
Requlatory Class: Class II Product Code: NUH Subsequent Product Code: NYN
Third Predicate
510K Number: K183110 Trade/Device Name: Livia Regulation Number: 21 CFR 882.5890 Classification Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH Subsequent Product Code: NGX
4. Device Description
"Wireless Electrical Stimulator" is a battery-powered wireless electrical stimulator designed and intended to provide Transcutaneous Electrical Nerve Stimulation (TENS) and Electrical Muscular Stimulation (EMS) for the use of non-pharmacological pain relief and improve muscle performance and recovery.
The "Wireless Electrical Stimulator" includes a remote control, stimulator pod(s) and several accessories. Both the remote control and the stimulator pod are powered by a 3.7V lithium-ion polymer battery. The remote control has a 1.77" TFT LCD screen and 4 buttons to control multiple stimulator pod(s) at the same time. Each stimulator pod has two output channels, and will perform electrical stimulation according to the parameter settings sent by the remote control. The stimulator pods can also be used independently via its own 3 buttons based on preset parameter.
The accessories include self-adhesive electrodes, kneelelbow brace, and the USB Type-C charging cable. The adhesive electrodes for "Wireless Electrical Stimulator" are connected with the Stimulator Pod(s) via magnetic snap and lead wire. There are replaceable hydrogel pads on the self-adhesive electrode pads. Users can replace the hydrogel when it exceeds its useful life, but does not need to discard the entire electrode. To apply electrical stimulation to body joints (e.g. knees and elbows), users can easily place electrodes on specific body parts using the Knee/elbow brace. The remote control and stimulator pods are the same for all models. The 3 models have different accessories to match their specific usage instructions. Below are the accessory variants for each model.
| Product Name | Wireless TENS/EMS | Brace TENS/EMS | Menstrual Pain Relief
TENS |
|---------------------|-------------------|--------------------------------------|----------------------------------------|
| Model | RS-18 | RS-28 | RS-38 |
| Indication of Use | General TENS/EMS | TENS/EMS for joint
(knee & elbow) | TENS for period pain
(dysmenorrhea) |
| Adhesive Electrodes | ● | ● | ● |
| Electrode Lead Wire | ● | ● | ● |
| Knee/Elbow Brace | n/a | ● | n/a |
5
USB Type C Charge Cable | • | • | • |
---|---|---|---|
------------------------- | --- | --- | --- |
Besides the accessory variants, the programs of all models also have some variants depend on the indication. RS-18 model has a "General TENS/EMS" indication, it includes all therapy programs. RS-28 model is indicated for "TENS/EMS for joint (knee & elbow)" and the RS-38 model is indicated for "TENS for period pain (dysmenorrhea)." Following are the program variants for each models.
Therapy Type | Program | RS-18 | RS-28 | RS-38 |
---|---|---|---|---|
Pain Relief | Acute Pain | ● | ● | ● |
Chronic Pain | ● | ● | ● | |
Soreness | ● | ● | ● | |
Pain Relief | Back Pain | ● | n/a | ● |
Menstrual | ||||
Cramping | ● | n/a | ● | |
Pain Relief | Arthritis | ● | ● | n/a |
Training | Warm-up | ● | ● | n/a |
Recovery | ● | ● | n/a | |
Atrophy | ● | ● | n/a | |
Strength | ● | ● | n/a | |
Endurance | ● | ● | n/a | |
Massage | Resistance | ● | ● | n/a |
Comfort | ● | ● | ● | |
Kneading | ● | ● | ● | |
Tapping | ● | ● | ● | |
Relaxation | ● | ● | ● | |
Tingling | ● | ● | ● | |
Alternating | ● | ● | ● |
6
5. Indications for Use
TENS:
[RS-18, RS-28, RS-38 models]: 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.
[RS-18, RS-38 models]: For temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medications.
[RS-18, RS-28 models]: It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
EMS:
[RS-18. RS-28]: To stimulate healthy muscles in order to improve and facilitate muscle performance.
Environments of Use: Clinics, hospital and home environments (over-the-counter) Patient Population: Adult
7
Comparison of Technological Characteristics with The Predicate Device
The "Wireless Electrical Stimulator" has been carefully compared to legally marketed devices with respect to intended use, indications for use (Table 1), technological characteristics (Table 2), and Output Specification (Table 3).
Table 1. Substantial Equivalence Table – Regulatory Information
Subject Device | Primary Predicate | Secondary Predicate | Third Predicate | |
---|---|---|---|---|
Trade/Device Name | Wireless Electrical | |||
Stimulator | Well Life Wireless | |||
TENS/EMS Stimulator, | ||||
Models WR- | ||||
2605A/2605 | Focus TENS Therapy, | |||
Model PM710-M/-L | Livia | |||
510(k) Number | K220997 | K161453 | K183215 | K183110 |
Manufacturer | ZMI Electronics Ltd. | Well-life Healthcare | ||
Limited | Omron Healthcare, Inc. | LifeCare Ltd. | ||
Classification | ||||
Product Code | NUH | NUH | NUH | NUH |
Subsequent | ||||
Product Codes | NGX, NYN | NGX, NYN | NYN | NGX |
Regulation | ||||
Number | 21 CFR 882.5890 | 21 CFR 882.5890 | 21 CFR 882.5890 | 21 CFR 882.5890 |
Regulation Name | Transcutaneous | |||
electrical nerve | ||||
stimulator for pain relief | Transcutaneous | |||
electrical nerve | ||||
stimulator for pain relief | Transcutaneous | |||
electrical nerve | ||||
stimulator for pain relief | Transcutaneous | |||
electrical nerve | ||||
stimulator for pain relief | ||||
Regulatory Class | Class II | Class II | Class II | Class II |
Indications for | For temporary relief of | For temporary relief of | The device is intended | For temporary relief of |
Use | ||||
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. | pain associated with | |||
sore and aching | ||||
muscles in the lower | ||||
back due to strain from | ||||
exercise or normal | ||||
household and work | ||||
activities. |
For temporary relief of
pain associated with
sore and aching
muscles in the upper
and lower extremities
(arm and/or leg) due to
strain from exercise or
normal household and
work activities. | for the relief of pain
associated with sore or
aching muscles of the
lower extremities (leg)
due to strain from
exercise or normal
household work
activities.
It is also intended for
the use of symptomatic
relief and management
of chronic, intractable
pain associated with
arthritis. | 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. |
| | For temporary relief of
pain associated with
dysmenorrhea
(menstrual cramps)
when used with over-
the-counter pain
medications. | For symptomatic relief
and management of
chronic, intractable pain
and relief of pain
associated with arthritis. | | For temporary relief of
pain associated with
dysmenorrhea
(menstrual cramps)
when used with over-
the-counter pain
medications. |
| | For symptomatic relief
and management of
chronic, intractable pain
and relief of pain
associated with arthritis. | For the stimulation of
healthy muscles in
order to improve or | | |
| | To stimulate healthy
muscles in order to | | | |
8
9
| | improve and facilitate
muscle performance. | facilitate muscle
performance. | | |
|---------------------------|------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|------------------------------------------------------------------|---------------------------------------------------|
| Environments of Use | Clinics, hospital and
home environments
(over-the-counter) | for home use, indoor,
not intended for
professional use (over-the-counter) | Clinics, hospital and
home environments
(over-the-counter) | home healthcare
environment (over-the-counter) |
| Patient
Population | Adult | At least 15 years old
and 8 years intensive
reading experience
(school), no maximum. | Adult | Be used only by women
aged 16 and above. |
| Over-the-Counter
(OTC) | Yes | Yes | Yes | Yes |
10
| | | Subject Device | Primary Predicate | Secondary
Predicate | Third Predicate |
|----------------------------|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Trade/Device Name | | Wireless Electrical
Stimulator | Well Life Wireless
TENS/EMS
Stimulator, Models
WR-2605A/2605 | Focus TENS
Therapy, Model
PM710-M/-L | Livia |
| 510(k) Number | | K220997 | K161453 | K183215 | K183110 |
| Power Source(s) | | 3.7V Lithium
polymer (LiPo)
battery | 3.7V Lithium
polymer (LiPo)
battery | Rechargeable
Lithium-ion battery | 3.7V Lithium ion
battery
(rechargeable) |
| Method of Line Current | | Output is electrically
disabled when
connect to charger,
by means of
microprocessor
charging circuit | Output is electrically
disabled when
connect to charger,
by means of
microprocessor
charging circuit | N/A (internal power
source) | Output is electrically
disabled when
connect to charger,
by means of
microprocessor
charging circuit |
| Patient Leakage Current | - Normal Condition (µA) |