(444 days)
Not Found
No
The description details a standard TENS/EMS device with manual controls and preset programs, with no mention of AI or ML capabilities.
Yes.
The device is designed for temporary relief of pain associated with sore and aching muscles (TENS function) and to stimulate healthy muscles to improve performance (EMS function), which are therapeutic applications.
No
The device description indicates its purpose is for "relief of pain" and to "improve and facilitate muscle performance" through electrical stimulation, which are therapeutic functions, not diagnostic ones.
No
The device description explicitly states it is a hand-held, battery-powered device with physical components like lead wires, electrodes, and pushbutton controls, indicating it is a hardware device that delivers electrical stimulation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for pain relief (TENS) and muscle stimulation (EMS). These are therapeutic and performance-enhancing applications, not diagnostic tests performed on samples taken from the body.
- Device Description: The device delivers electrical stimulation to the skin. It does not analyze biological samples (like blood, urine, tissue, etc.) to provide diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic results.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease or injury. This device does not fit that description.
N/A
Intended Use / Indications for Use
TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.
EMS: The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
Product codes
NUH, NGX
Device Description
Perfect EMS is a hand-held, home-use device designed to relief of pain and improve and facilitate muscle performance. Perfect EMS is intended for over-the-counter use.
The device is battery powered, two channels home use neuromuscular stimulation. The device is supplied with self-adhesive electrodes which connect to the control unit by cable and plug and are placed on patients' intact skin by the end user. Electrical stimulation is delivered via self-adhesive electrodes to nerves and muscles.
The level of electrical stimulation is easily controlled by the end user using manual, pushbutton controls.
The unit is intended for home use by the patient, and is designed with simplicity and ease of use in mind. It has six preset treatment programs and four manually adjustable programmes are available.
Accessories: 2 x 1.25m PVC Lead Wires (L-CPT) 50x50mm hydrogel electrode pads (E-CM5050)
Optional accessories: 50x100mm Large hydrogel electrode pads Pack of 4 (E-CM50100)
ENVIRONMENT OF USE: Clinics, hospital and home environments
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), lower extremities (leg), abdomen and bottom
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home-use device, for use by the patient.
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)
A series of safety and performance tests were conducted on the subject device Perfect EMS including:
- ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
- IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1-11 Edition 2.0 2015-01 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- IEC 60601-2-10 Edition 2.1 2016-04 Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
- IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION Medical device software - Software life cycle processes
- ANSI AAMI ISO 10993-1:2009/(R)2013 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, including Cytotoxicity (per ISO 10993-5), Sensitization (per ISO 10993-10), and Irritation (per ISO 10993-10).
All the test results demonstrate Perfect EMS meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 4, 2021
TensCare Ltd. Andrew Brown Quality Manager 9 Blenheim Road, Longmead Business Park Epsom, Surrey KT19 9BE United Kingdom
Re: K200694
Trade/Device Name: Perfect EMS Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: May 1, 2021 Received: May 17, 2021
Dear Andrew Brown:
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 con tract 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
1
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 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, Sub part 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,
Heather Dean, PhD Assistant Director. Acute Injurv Devices Team 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) K200694
Device Name Perfect EMS
Indications for Use (Describe)
TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.
EMS: The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
| 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) | X |
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3
510(k) Summary
K200694
Date of Subimission prepared: March 5, 2020
| Submitter : | Tenscare Ltd |
|---|---|
| Address: | 9 Blenheim Road, Longmead Business Park, Epsom, |
| Surrey, KT19 9BE, United Kingdom | |
| Tel : | +44(0)1372 723 434 |
| Fax : | +44(0)1372 745 434 |
| E-Mail : | andrew@tenscare.co.uk |
| FDA Establishment | |
| Registration No: | 3003446042 |
| Contact person: | Andrew Brown |
Address of the manufacturing facility:
EasyMed Instruments Co Ltd 3/F, 5F/6F, Block A, Gupo Gongmao Building, Fengxin Road, Fengxiang Industrial District, Daliang, 528300 Shunde, Foshan, Guangdong, China,
FDA Establishment Registration No: 3004049909
Address of American Representative:
| Contact First Name; | SCOTT A |
|---|---|
| Contact Last Name: | BEDNAR |
| Title: | MR |
| Business Name: | QA/RA CONSULTING GROUP, INC. |
| Full Address: | 3335 TUSCARAWAS ROAD |
| BEAVER, PENNSYLVANIA, 15009, UNITED STATES | |
| E-mail: | sbednar@qaraconsultinggroup.com |
| Phone Number: | 412-4188066 |
ll Submitted Device:
| Trade name: | Perfect EMS |
|---|---|
| Common name: | Transcutaneous Electrical Nerve Stimulator (TENS) / |
| Electrical Muscle Stimulator (EMS) | |
| Classification Number: | 21 CFR 882.5890; |
| 21 CFR 890.5850 | |
| Classification name: | Transcutaneous electrical nerve stimulator for pain relief; |
| Powered muscle stimulator | |
| Product Code: | NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter); |
| NGX (Stimulator, Muscle, Powered, For Muscle Conditioning) | |
| Classification Panel: | Neurology; Physical Medicine |
| Regulatory Class: | Class II |
4
��� Predicate Device:
| Predicate Device: | HIVOX OTC Electrical Stimulator |
|---|---|
| Trade/Device Name: | EM49-2 |
| Model Number: | HIVOX BIOTEK INC. |
| Manufacturer: | K190347 |
| 510(k) Number: | NUH, NGX |
| Product Code: | Over-The-Counter Use (OTC Use |
| Type of Use: | Class II |
| Regulatory Class: |
Device Description: IV
Perfect EMS is a hand-held, home-use device designed to relief of pain and improve and facilitate muscle performance. Perfect EMS is intended for over-the-counter use.
The device is battery powered, two channels home use neuromuscular stimulation. The device is supplied with self-adhesive electrodes which connect to the control unit by cable and plug and are placed on patients' intact skin by the end user. Electrical stimulation is delivered via self-adhesive electrodes to nerves and muscles.
The level of electrical stimulation is easily controlled by the end user using manual, pushbutton controls.
The unit is intended for home use by the patient, and is designed with simplicity and ease of use in mind. It has six preset treatment programs and four manually adjustable programmes are available.
Accessories: 2 x 1.25m PVC Lead Wires (L-CPT) 50x50mm hydrogel electrode pads (E-CM5050)
Optional accessories: 50x100mm Large hydrogel electrode pads Pack of 4 (E-CM50100)
ENVIRONMENT OF USE: Clinics, hospital and home environments
Indications for Use of the device: >
TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.
EMS: The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
5
The Perfect EMS is intended for OTC use.
The indications for use of the Perfect EMS are the same as those of the predicate device HIVOX OTC Electrical Stimulator Model: EM49-2 (K190347).
VI Equivalence Comparison to the Predicate Devices:
Electrical nerve and muscle stimulation is the technological principle for both the Perfect EMS and the predicate device EM49-2 (K190347).
The technical characteristics of Perfect EMS are similar to those of the predicate device in design, intended use and function. The predicate device EM49-2 (K190347) and the Perfect EMS are devices apply an electrical current via electrodes to a patient's nerves and muscles.
The stimulation parameters of Perfect EMS are similar to those of predicate device EM49-2 (K190347). Perfect EMS totally has 10 programs, the parameter of Perfect EMS are all in the same range of those of predicate device EM49-2 (K190347).
Table 1 below summarizes the shared and unique technological elements between the Perfect EMS and EM49-2 (K190347). The technology, engineering, and performance for Perfect EMS are substantially equivalent to the predicate device.
From the view of safety and effectiveness, the output characteristics of Perfect EMS are similar to those of predicate device EM49-2 (K190347), see Table 1. The Perfect EMS is designed to comply with relevant safety applicable recognized consensus standards: the output energy is controlled well within the safety and effectiveness ranges specified by relevant FDA guidance. Detailed and strictly controlled testing has been carried out. The maximum power density of Perfect EMS is less than 0.25 watts per square centimeter of electrode conductive surface area to reduce the risk of thermal burns. Furthermore, Test results, Risk Analysis, and FMEA analysis show that the Perfect EMS is safe with no hazard.
As such:
-
the Perfect EMS has similar technological characteristics and intended uses as the predicate EM49-2 (K190347): and
-
the information submitted to the FDA for the Perfect EMS does not raise new questions about safety or effectiveness and demonstrates with reasonable assurance based on established controls that the device is at least as safe and effective as a legally marketed device.
6
Table 1 Substantial Equivalence Comparison Table
| Attribute | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| Product Name | Perfect EMS | EM49-2 | |
| 510(K) number | K200694 | K190347 | |
| Product Code | NUH, NGX | NUH, NGX | Identical codes; |
| Substantially | |||
| equivalent | |||
| Regulation No. | 21 CFR 882.5890; | ||
| 21 CFR 890.5850 | 21 CFR 882.5890; | ||
| 21 CFR 890.5850 | Identical; | ||
| Substantially | |||
| equivalent | |||
| Manufacturer | TensCare Ltd | HIVOX BIOTEK INC. | |
| Indications | |||
| for Use | TENS: The device is | ||
| designed to be used for | |||
| temporary relief of pain | |||
| associated with sore and | |||
| aching muscles in the | |||
| shoulder, waist, back, neck, | |||
| upper extremities (arm), | |||
| lower extremities (leg), | |||
| abdomen and bottom due to | |||
| strain from exercise or normal | |||
| household work activities. |
EMS: The device is designed
to be used for stimulate
healthy muscles in order to
improve and facilitate muscle
performance. | TENS: The device is
designed to be used for
temporary relief of pain
associated with sore and
aching muscles in the
shoulder, waist, back, neck,
upper extremities (arm),
lower extremities (leg),
abdomen and bottom due to
strain from exercise or
normal household work
activities.
EMS: The device is designed
to be used for stimulate
healthy muscles in order to
improve and facilitate muscle
performance. | Same indications
for use;
Substantially
equivalent |
| Prescriptive or OTC | OTC | OTC | Identical;
Substantially
equivalent |
| Number
of
output
modes | 10 | 70* | Substantially
equivalent |
| Number
of
output
channels | 2 | 2* | Substantially
equivalent |
| Timer
(minutes)
Range | Default 20 minutes.
Adjustable to 10, 20, 30, 45,
60, 90 minutes | Default 30 minutes.
Adjustable from 5 to 100
minutes* | Both are
adjustable;
Substantially
Equivalent |
| Regulated Current or
Regulated Voltage? | None | None* | Substantially
Equivalent. |
| Attribute | Subject Device | Predicate Device | Comparison |
| Software/Firmware/
Microprocessor
Control? | Yes | Yes * | Identical control
method |
| Automatic
No-Load
Trip? | Yes | Yes* | Identical |
| Automatic
Overload
Trip? | Yes | Yes* | Identical |
| Automatic Shut Off? | Yes | Yes* | Identical |
| User Override
Control? | Yes | Yes* | Substantially
Equivalent. |
| Indicator Display:
-On/Off status | Yes | Yes* | Identical |
| -Low battery | Yes | Yes* | |
| -Voltage/Current level | Yes | Yes* | |
| -Time to cut-off | Yes | Yes* | |
| Frequency (Hz) | 1-120Hz | 1-150Hz* | Substantially
equivalent |
| Pulse Width (μs) | 50-350μs | 50-450μs* | Substantially
equivalent |
| Waveform | Bi-phasic | Bi-phasic* | Identical |
| Shape | Rectangular | Rectangular* | Identical |
| Maximum Output
Voltage (V) | 50V@ 500Ω | 50V@ 500Ω* | Substantially
equivalent |
| Maximum Output
Current (mA) | 100mA@ 500Ω | 100mA@ 500Ω* | Substantially
equivalent |
| Maximum Phase
Charge (μC) | 20.5μC@ 500Ω | 37.6μC@ 500Ω* | Substantially
equivalent |
| Maximum Current
Density, (mA/cm²) | 0.01013mA/cm²@ 500Ω
(Area=25cm²) | 0.07426mA/cm²@ 500Ω*
(Area=20.25cm²) | Substantially
equivalent |
| Maximum Power
Density, (W/cm²) | 0.00053W/cm²@ 500Ω
(Area=25cm²) | 0.0066W/cm²@ 500Ω*
(Area=20.25cm²) | Substantially
equivalent |
| Power Source | 2 Alkaline AA 1.5V Batteries | 3 Alkaline AAA 1.5V
Batteries | Both are internal power supply
source:
Substantially
equivalent |
| Weight | 120 x 60 x 31mm | 132 x 63 x 29.5 mm* | Substantially
Equivalent. |
| Dimensions (mm) [W
x H x D] | 75 g without batteries | 83 g without batteries* | Substantially
Equivalent. |
| Housing Materials
and Construction | Silicone, ABS plastics | ABS plastics * | Substantially
Equivalent. |
| Electrode lead wires
and patient cable | Yes
(PVC and nylon yarn) | Yes*
PVC | Substantially
equivalent |
| Attribute | Subject Device | Predicate Device | Comparison |
| compliance with 21
CFR 898 | | | |
| Compliance
with
Voluntary Standards | Yes
See section 1.3 | Yes*
See section 1.3 | Substantially
equivalent |
7
8
Remark: The information marks with * means the information is not publicly available
9
VII Performance Tests:
A series of safety and performance tests were conducted on the subject device Perfect EMS See below:
| FDA recognition No. | Standard Title |
|---|---|
| 19-4 | ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, |
| C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) | |
| Medical electrical equipment - Part 1: General requirements for | |
| basic safety and essential performance (IEC 60601-1:2005, MOD) | |
| 19-8 | IEC 60601-1-2 Edition 4.0 2014-02 |
| Medical electrical equipment - Part 1-2: General requirements for | |
| basic safety and essential performance - Collateral Standard: | |
| Electromagnetic disturbances - Requirements and tests | |
| 19-14 | IEC 60601-1-11 Edition 2.0 2015-01 |
| Medical electrical equipment - Part 1-11: General requirements for | |
| basic safety and essential performance - Collateral Standard: | |
| Requirements for medical electrical equipment and medical | |
| electrical systems used in the home healthcare environment. | |
| 17-16 | IEC 60601-2-10 Edition 2.1 2016-04 |
| Medical electrical equipment - Part 2-10: Particular requirements for | |
| the basic safety and essential performance of nerve and muscle | |
| stimulators | |
| 13-79 | IEC 62304 Edition 1.1 2015-06 CONSOLIDATED |
| VERSION Medical device software - Software life cycle processes | |
| 2-220 | ANSI AAMI ISO 10993-1:2009/(R)2013 |
| Biological evaluation of medical devices - Part 1: Evaluation and | |
| testing within a risk management process | |
| Three biocompatibility tests conducted: | |
| Cytotoxicity (per ISO 10993-5) |
Sensitization (per ISO 10993-10)
Irritation (per ISO 10993-10)
- |
All the test results demonstrate Perfect EMS meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate device.
10
VII Conclusion:
- � The Perfect EMS has the same technological characteristics and intended uses as the predicateEM49-2 (K190347); and
- � The labelling of the Perfect EMS is concordant with the predicate device and FDA requirements; and
- � The information submitted to the FDA for the Perfect EMS does not raise new questions about safety or effectiveness and demonstrates with reasonable assurance based on established controls that the device is at least as safe and effective as a legally marketed device.
Therefore, the Perfect EMS is substantially equivalent to the predicate device.