Unipro (K-UNIPRO-US)
Device Facts
| Record ID | K232441 |
|---|---|
| Device Name | Unipro (K-UNIPRO-US) |
| Applicant | Tenscare, Ltd. |
| Product Code | GZJ · Neurology |
| Decision Date | Aug 30, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.5890 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
TENS stands for Transcutaneous Electrical Nerve Stimulation. Unipro TENS is used to provide symptomatic pain relief for chronic, acute or post-operative pain. EMS stands for Electrical Neuromuscular Stimulation. Unipro EMS is indicated for: - Relaxation of muscle spasm - Increasing local blood circulation and muscle re-education - Prevention or retardation of disuse atrophy - Prevention of venous thrombosis of the calf muscles immediately after surgery - Maintaining on increasing range of motion MIC stands for Microcurrent Stimulation. Unipro MIC is used to provide sumptomatic pain relief for chronic intractable pain, post traumatic pain or post surgical pain. IFT stands for Interferntial Stimulation. Unipro IFT is indicated for symptomatic relief of chronic intractable pain.
Device Story
Unipro is a portable, microprocessor-controlled, non-invasive, non-sterile, reusable neuromuscular electrical stimulator; powered by internal Li-ion battery. Device combines four therapy modes: TENS, EMS, MIC, and IFT. User selects mode via button interface; intensity defaults to zero upon mode change for safety. Device delivers electrical current to nerves/muscles via self-adhesive electrodes applied to skin. Used in hospital or home settings by patients or clinicians. Output parameters (voltage, current, pulse width, frequency) are controlled by internal software. Healthcare providers use device to manage pain and support muscle rehabilitation. Benefits include symptomatic pain relief, muscle spasm relaxation, improved circulation, and prevention of disuse atrophy. Device features automatic no-load trip and shut-off functions.
Clinical Evidence
No clinical testing performed. Substantial equivalence supported by bench testing (mechanical, electrical, software) and a formal review of published literature/clinical evaluation regarding the safety and effectiveness of TENS, EMS, IFT, and MIC technologies.
Technological Characteristics
Portable electrotherapy device; ABS 757 housing; 3.7V 1500mAh Li-ion battery. Sensing/actuation via electrical stimulation through skin electrodes. Connectivity: standalone. Sterilization: non-sterile. Software: microprocessor-controlled, multi-mode (TENS, EMS, MIC, IFT). Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11, IEC 62304, IEC 62366-1, ISO 10993, ISO 14971, ISO 13485.
Indications for Use
Indicated for male and female patients over age 21 requiring pain relief for chronic, acute, or post-operative pain, or musculo-skeletal injuries, and for muscle rehabilitation/training. Contraindicated for patients under age 22, those in the first three months of pregnancy, and those with pacemakers or heart rhythm problems.
Regulatory Classification
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.
Predicate Devices
- Ultima NEO (K120054)
Submission Summary (Full Text)
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August 30, 2024
TensCare Ltd Saskia Eldridge-Hinmers Ouality Assurance & Regulatory Affairs Executive 9 Blenheim Road Epsom, Surrey KT19 9BE United Kingdom
Re: K232441 Trade/Device Name: Unipro (K-UNIPRO-US) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZJ, IPF, LIH Dated: August 28, 2024 Received: August 28, 2024
Dear Saskia Eldridge-Hinmers:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 L. Dean -S
for Pamela Scott
Assistant Director, Neuromodulation - Psychiatry Devices DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices
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Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
Submission Number (if known)
# K232441
Device Name
Unipro (K-UNIPRO-US)
Indications for Use (Describe)
TENS stands for Transcutaneous Electrical Nerve Stimulation. Unipro TENS is used to provide symptomatic pain relief for chronic, acute or post-operative pain.
EMS stands for Electrical Neuromuscular Stimulation. Unipro EMS is indicated for:
- · Relaxation of muscle spasm
- · Increasing local blood circulation and muscle re-education
- · Prevention or retardation of disuse atrophy
- · Prevention of venous thrombosis of the calf muscles immediately after surgery
- · Maintaining on increasing range of motion
MIC stands for Microcurrent Stimulation. Unipro MIC is used to provide sumptomatic pain relief for chronic intractable pain, post traumatic pain or post surgical pain.
IFT stands for Interferntial Stimulation. Unipro IFT is indicated for symptomatic relief of chronic intractable pain.
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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TensCare LTD. 9 Blenheim Road Epsom, Surrey, KT19 9BE United Kingdom
# 5. 510(k) SUMMARY - K232441
#### 5.1. Submitters Identification
| Submitter: | TensCare Ltd |
|------------------------------------|-------------------------------------------------------------|
| Address: | 9 Blenheim Road, Epsom,<br>Surrey, KT19 9BE, United Kingdom |
| Tel: | +44(0)1372 723 434 |
| Fax: | +44(0)1372 745 434 |
| FDA Establishment Registration No: | 3003446042 |
| Contact person: | Saskia Eldridge-Hinmers |
|-----------------|----------------------------------------|
| | Regulatory Affairs Associate |
| Contact Phone: | +44(0)7879424785 |
| Contact Email: | Saskia.Eldridge-Hinmers@tenscare.co.uk |
| Date Prepared: | 20.March. 2024 |
## 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<br>BEAVER, PENNSYLVANIA, 15009, UNITED STATES |
| E-mail: | sbednar@qaraconsultinggroup.com |
| Phone Number: | 412 -4188066 |
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# 5.2. Subject Device
| Manufacturer | : Tenscare Limited |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade/Device Name | : Unipro (K-UNIPRO-USA) |
| 510(k) Number | : K232441 |
| Device Classification Name | : Stimulator, Nerve, Transcutaneous, for pain relief |
| Common Name: | : For the TENS/MIC system-TENS device<br>For the EMS system-Powered Muscle Stimulators<br>For the IF system-interferential Stimulator |
| Classification Name | : For TENS / MIC system<br>Stimulator, Nerve, Transcutaneous, for Pain Relief - GZJ<br>For EMS system<br>Powered Muscle Stimulator - IPF<br>For IF system<br>Interferential current therapy - LIH |
| CFR Regulation Number | : 21 CFR 882.5890 and 21 CFR 890.5850 |
| Product Code | : GZJ, IPF, LIH |
| FDA Device Classification | : Class II |
#### Predicate Devices 5.3.
#### 5.3.1. Predicate Device
| Manufacturer | : EasyMed Instruments Co., Ltd |
|----------------------------|--------------------------------------------------------------|
| Trade/Device Name | : Ultima NEO |
| 510(k) Number | : K120054 |
| Device Classification Name | : Stimulator, Nerve, Transcutaneous, for pain relief |
| Regulation Description | : Transcutaneous Electrical Nerve Stimulator for Pain Relief |
| CFR Regulation Number | : 21 CFR 882.5890 and 21 CFR 890.5850 |
| Product Code | : GZJ, IPF, LIH |
| FDA Device Classification | : Class II |
| Device Type ID | : 3755 |
#### 5.4. Device Description
Unipro is a non-invasive, non-sterile, reusable medical device which is intended to be used in both the hospital and home healthcare environment. It is a microprocessor controlled, non-implantable, portable neuromuscular electrical stimulator which is powered by a built in Li-ion rechargeable battery.
Unipro is a multitherapy unit that combines the treatment capabilities of TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscle Stimulation), MIC (Microcurrent Stimulation) and IFT (Interferential Therapy). The mode selection button on device will enable the user to switch between different modes (TENS, EMS II, EMS III, or massage). Each time the user changes the mode or
Tenscare Ltd., Traditional 510(k) Unipro
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program, the intensity level will revert to zero. This is a safety feature to alleviate any sudden feeling of a surge, as each program gives a different sensation.
Unipro Case L (large) features a white ABS case with a white silicone button pad and white power button. Power button is located on the right-hand side of the device. The hardware features a black perimeter border and black LCD display. Charging cable and lead inserts are located on the bottom of the device.
Unipro is supplied with self-adhesive electrodes which attach to the control unit via lead wires. A gentle electrical current is sent to underlying nerves and muscle groups via these electrodes applied on the skin to relieve pain. Placement of the electrode pads of the device depends on the selected device mode (TENS, EMS, IFT2, IFT4, MIC). For TENS, the easiest way is to apply the electrode pads around/near the source of the pain. For EMS, place two electrode pads over the bulk of the muscle, with one electrode over the muscle's motor point. For IFT2, electrodes should be placed either side of the area of pain and for IFT4, the pads need to apply in positions so that the signals from each channel cross over the point to be treated. Finally, for MIC, the electrode pads should be placed in such a way that a straight line between them passes through the problem area.
The subject device has no fixed shelf life. The machine will often last for more than 5 years but is warrantied for 2 years. As it is an electronic device, it must not be disposed of as general, domestic waste and must comply with FDA regulation and environmental protection rules for safe disposal of electronic waste.
An unopened pack of electrode pads is intended to last up to two years, which may vary following exposure to low humidity or high temperatures. Once used, the electrode pads are expected to last 12-20 applications, depending on skin condition and humidity. The electrode pads can then be disposed of as standard domestic waste. The subject device and associated accessories are supplied non-sterile.
#### Indication For Use/Intended Use 5.5.
TENS stands for Transcutaneous Electrical Nerve Stimulation. The Unipro TENS system is used to provide symptomatic pain relief for chronic, acute or post-operative pain.
EMS stands for Electrical Neuromuscular Stimulator. The Unipro EMS system is indicated for:
- . Relaxation of muscle spasm
- . Increasing local blood circulation and muscle re-education
- . Prevention or retardation of disuse atrophy
- Prevention of venous thrombosis of the calf muscles immediately after surgery
- . Maintaining or increasing range of motion.
MIC stands for Microcurrent Stimulation. -The Unipro MIC system is used to provide symptomatic pain
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relief for chronic intractable pain, post traumatic pain or post-surgical pain. IF stands for Interferential Stimulation. The Unipro system is indicated for:
- Symptomatic relief of chronic intractable pain. ●
#### 5.6. Indication for Use comparison
# TABLE 1: Indication For Use Comparison Table
| Characteristic | New Device<br>Unipro | Predicate Device<br>Ultima NEO | Comparison |
|----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Manufacturer | Tenscare Limited | EasyMed Instruments<br>Co., Ltd | - |
| 510(k) No. | K232441 | K120054 | - |
| Indications for<br>Use | TENS stands for Transcutaneous Electrical<br>Nerve Stimulation. The<br>Unipro TENS system is used<br>to provide symptomatic pain<br>relief for chronic, acute or<br>post-operative pain.<br><br>EMS stands for Electrical<br>Neuromuscular Stimulator.<br>The Unipro EMS system is<br>indicated for:<br>-Relaxation of muscle spasm<br>-Increasing local blood<br>circulation and muscle re-<br>education<br>-Prevention or retardation of<br>disuse atrophy<br>-Prevention of venous<br>thrombosis of the calf<br>muscles immediately after<br>surgery<br>-Maintaining or increasing<br>range of motion.<br><br>MIC stands for Microcurrent<br>Stimulation. -The Unipro<br>MIC system is used to<br>provide symptomatic pain<br>relief for chronic intractable<br>pain, post traumatic pain or<br>post-surgical pain. | TENS stands for Transcutaneous Electrical<br>Nerve Stimulation. The<br>Ultima NEO TENS<br>system is used to provide<br>symptomatic pain relief<br>for chronic, acute or post-<br>operative pain.<br><br>EMS stands for Electrical<br>Neuromuscular<br>Stimulator. The Ultima<br>NEO EMS system is<br>indicated for:<br>-Relaxation of muscle<br>spasm<br>-Increasing local blood<br>circulation and muscle re-<br>education<br>-Prevention or retardation<br>of disuse atrophy<br>-Prevention of venous<br>thrombosis of the calf<br>muscles immediately<br>after surgery<br>-Maintaining or<br>increasing range of<br>motion.<br><br>MIC stands for<br>Microcurrent Stimulation.<br>The Ultima NEO MIC | Identical |
| Characteristic | New Device<br>Unipro | Predicate Device<br>Ultima NEO | Comparison |
| | IF stands for Interferential<br>Stimulation. The Unipro IF<br>system is indicated for:<br>-Symptomatic relief of<br>chronic intractable pain. | system is used to provide<br>symptomatic pain relief<br>for chronic intractable<br>pain, post traumatic pain<br>or post-surgical pain.<br>IF stands for Interferential<br>Stimulation. The Ultima<br>Neo system is indicated<br>for:<br>-Symptomatic relief of<br>chronic intractable pain. | |
| Intended<br>population | Male and female patients<br>over the age of 21 requiring<br>pain relief for various types<br>of pain, progress their<br>rehabilitation post injury and<br>encourage results from<br>sports training. Target<br>population includes those<br>who fit this criteria with<br>chronic, acute or post-<br>operative pain and/or<br>Musculo-skeletal injuries.<br>The device should not be<br>used by patients:<br>- Under the age of 22<br>- During first three<br>months of<br>pregnancy<br>- Who have a<br>pacemaker or heart<br>rhythm problems | Male and female patients<br>over the age of 18 years<br>old. | Substantially Equivalent |
| Class | II | II | Identical |
| Product code | GZJ, IPF, LIH | GZJ, IPF, LIH | Identical |
| Regulation<br>number | 21 CFR 882.5890 and 21<br>CFR 890.5850 | 21 CFR 882.5890 and 21<br>CFR 890.5850 | Identical |
| Characteristic | New Device | Predicate Device | Comparison |
| Device<br>Name/Model | Unipro | Ultima NEO | |
| 510(k) | K232441 | K120054 | |
| Manufacturer | TensCare Ltd | EasyMed Instruments Co.,<br>Ltd | |
| Power Source(s)¹ | 3.7V 1500mAh Lithium-ion<br>battery(rechargeable) | 3.7V Lithium-ion<br>battery(rechargeable) | No substantial<br>difference |
| Method of Line<br>current Isolation | Sequential isolation /<br>transformer isolation | Not publicly available | |
| Average DC current<br>through Electrodes<br>when device is on but<br>no pulses are being<br>applied (µA) | 0 | 0 | Identical |
| Number of Output<br>Modes | 4 | 4 | Identical |
| Number of programs<br>modes | 76 | 41 | No substantial<br>difference.<br>Both comply with<br>IEC 60601-1<br>requirements |
| Number of Output<br>Channels | 2 | 2 | Identical |
| Timer<br>Range<br>(minutes) | 5-90 minutes, constant | 10-90 minutes, constant | No substantial<br>difference.<br>Unipro can be set to<br>lower setting |
| Regulated Current or<br>Voltage? | Current and Voltage | Current and Voltage | Identical |
| Software/Firmware/<br>Microprocessor<br>Control? | Yes | Yes | Identical |
| Automatic No-Load<br>Trip? | Yes (TENS/EMS) | Not publicly available | |
| Automatic Overload<br>Trip? | No | Not publicly available | |
| Automatic Shut Off? | Yes | Not publicly available | |
| User Override<br>Control? | Yes | Not publicly available | |
| Indicator Display:<br>-On/Off status<br>-Low battery<br>-Voltage/Current<br>level<br>-Time to cut-off | Yes<br>Yes<br>Yes<br>Yes | Yes<br>Yes<br>Yes<br>Yes | Identical |
| Characteristic<br>Device<br>Name/Model | New Device | Predicate Device | Comparison |
| Unipro | Ultima NEO | | |
| Compliance<br>Voluntary<br>Standards? | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-10<br>IEC 60601-1-11<br>IEC 62304<br>IEC 60601-1-6<br>IEC 62366-1<br>ISO 10993- 5, 10 and 12<br>ISO 14971<br>ISO 13485 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-4<br>IEC 60601-2-10<br>IEC/EN 62304<br>ISO 14971<br>ISO 13485<br>IC council 93/42/EEC<br>UL 60601-1 | Substantial<br>equivalent |
| Compliance with 21<br>CFR 890.5850 and<br>21 CFR 882.5890 | Yes | Yes | Identical |
| Dimensions (mm) | 125mm x 62mm x 29.6mm. | 123 x 61 x 22mm (excluding<br>belt clip) | Different, the different dimensions does not affect the safety and effectiveness. |
| Weight g | 128.5g | 160g (including battery) | Different, the different weight does not affect the safety and effectiveness. |
| Housing<br>Materials<br>and Construction | ABS 757 material | ABS 757 material | Identical |
| Sterilization | N/A | N/A…
