(382 days)
Not Found
No
The document describes a standard electrical stimulator with multiple modes and a microprocessor for control, but there is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is intended for symptomatic pain relief, muscle stimulation, and management of various conditions like muscle spasm and disuse atrophy, which are all therapeutic purposes.
No
The device is described as a non-invasive, non-sterile, reusable medical device intended for symptomatic pain relief and muscle stimulation/re-education. Its functions (TENS, EMS, MIC, IFT) are therapeutic in nature, not diagnostic.
No
The device description explicitly states it is a "microprocessor controlled, non-implantable, portable neuromuscular electrical stimulator" and describes physical components like a case, buttons, LCD display, charging cable, lead inserts, and electrodes. 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:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Unipro device is a non-invasive electrical stimulator that applies electrical currents to the skin for pain relief and muscle stimulation. It does not analyze samples taken from the body.
- Intended Use: The intended uses described (pain relief, muscle stimulation) are therapeutic and rehabilitative, not diagnostic.
Therefore, the Unipro device falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
GZJ, IPF, LIH
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Male and female patients over the age of 21.
The device should not be used by patients:
- Under the age of 22
Intended User / Care Setting
Used in both the hospital and home healthcare environment.
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
No clinical testing was considered necessary.
Tenscare conducted a formal review of published research and clinical evaluation on the use of TENS, EMS, IFT and MC in pain relief for chronic, acute, or post-operative pain as well as muscle training, toning, bulking and re-education to establish evidence of the safety and effectiveness of these settings for this Indicated Use and electrode positions.
Unipro has undergone extensive bench testing to provide evidence that its mechanical, electrical and software properties are substantially equivalent to the predicate devices, Ultima NEO (K120054). Both Subject and Predicate devices are provided non-sterile, have comparable operations and technology. The design of Unipro does not introduce any new risks.
Key Metrics
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 contains 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.
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"
1
(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
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
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, |
| 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 |
| BEAVER, PENNSYLVANIA, 15009, UNITED STATES | |
| E-mail: | sbednar@qaraconsultinggroup.com |
| Phone Number: | 412 -4188066 |
5
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 |
| For the EMS system-Powered Muscle Stimulators | |
| For the IF system-interferential Stimulator | |
| Classification Name | : For TENS / MIC system |
| Stimulator, Nerve, Transcutaneous, for Pain Relief - GZJ | |
| For EMS system | |
| Powered Muscle Stimulator - IPF | |
| For IF system | |
| 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
6
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
7
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
Unipro | Predicate Device
Ultima NEO | Comparison |
|----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Manufacturer | Tenscare Limited | EasyMed Instruments
Co., Ltd | - |
| 510(k) No. | K232441 | K120054 | - |
| Indications for
Use | 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
relief for chronic intractable
pain, post traumatic pain or
post-surgical pain. | TENS stands for Transcutaneous Electrical
Nerve Stimulation. The
Ultima NEO TENS
system is used to provide
symptomatic pain relief
for chronic, acute or post-
operative pain.
EMS stands for Electrical
Neuromuscular
Stimulator. The Ultima
NEO 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 Ultima NEO MIC | Identical |
| Characteristic | New Device
Unipro | Predicate Device
Ultima NEO | Comparison |
| | IF stands for Interferential
Stimulation. The Unipro IF
system is indicated for:
-Symptomatic relief of
chronic intractable pain. | system is used to provide
symptomatic pain relief
for chronic intractable
pain, post traumatic pain
or post-surgical pain.
IF stands for Interferential
Stimulation. The Ultima
Neo system is indicated
for:
-Symptomatic relief of
chronic intractable pain. | |
| Intended
population | Male and female patients
over the age of 21 requiring
pain relief for various types
of pain, progress their
rehabilitation post injury and
encourage results from
sports training. Target
population includes those
who fit this criteria with
chronic, acute or post-
operative pain and/or
Musculo-skeletal injuries.
The device should not be
used by patients:
- Under the age of 22
- During first three
months of
pregnancy - Who have a
pacemaker or heart
rhythm problems | Male and female patients
over the age of 18 years
old. | Substantially Equivalent |
| Class | II | II | Identical |
| Product code | GZJ, IPF, LIH | GZJ, IPF, LIH | Identical |
| Regulation
number | 21 CFR 882.5890 and 21
CFR 890.5850 | 21 CFR 882.5890 and 21
CFR 890.5850 | Identical |
| Characteristic | New Device | Predicate Device | Comparison |
| Device
Name/Model | Unipro | Ultima NEO | |
| 510(k) | K232441 | K120054 | |
| Manufacturer | TensCare Ltd | EasyMed Instruments Co.,
Ltd | |
| Power Source(s)¹ | 3.7V 1500mAh Lithium-ion
battery(rechargeable) | 3.7V Lithium-ion
battery(rechargeable) | No substantial
difference |
| Method of Line
current Isolation | Sequential isolation /
transformer isolation | Not publicly available | |
| Average DC current
through Electrodes
when device is on but
no pulses are being
applied (µA) | 0 | 0 | Identical |
| Number of Output
Modes | 4 | 4 | Identical |
| Number of programs
modes | 76 | 41 | No substantial
difference.
Both comply with
IEC 60601-1
requirements |
| Number of Output
Channels | 2 | 2 | Identical |
| Timer
Range
(minutes) | 5-90 minutes, constant | 10-90 minutes, constant | No substantial
difference.
Unipro can be set to
lower setting |
| Regulated Current or
Voltage? | Current and Voltage | Current and Voltage | Identical |
| Software/Firmware/
Microprocessor
Control? | Yes | Yes | Identical |
| Automatic No-Load
Trip? | Yes (TENS/EMS) | Not publicly available | |
| Automatic Overload
Trip? | No | Not publicly available | |
| Automatic Shut Off? | Yes | Not publicly available | |
| User Override
Control? | Yes | Not publicly available | |
| Indicator Display:
-On/Off status
-Low battery
-Voltage/Current
level
-Time to cut-off | Yes
Yes
Yes
Yes | Yes
Yes
Yes
Yes | Identical |
| Characteristic
Device
Name/Model | New Device | Predicate Device | Comparison |
| Unipro | Ultima NEO | | |
| Compliance
Voluntary
Standards? | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-10
IEC 60601-1-11
IEC 62304
IEC 60601-1-6
IEC 62366-1
ISO 10993- 5, 10 and 12
ISO 14971
ISO 13485 | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-4
IEC 60601-2-10
IEC/EN 62304
ISO 14971
ISO 13485
IC council 93/42/EEC
UL 60601-1 | Substantial
equivalent |
| Compliance with 21
CFR 890.5850 and
21 CFR 882.5890 | Yes | Yes | Identical |
| Dimensions (mm) | 125mm x 62mm x 29.6mm. | 123 x 61 x 22mm (excluding
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
Materials
and Construction | ABS 757 material | ABS 757 material | Identical |
| Sterilization | N/A | N/A | Identical |
Tenscare Ltd., Traditional 510(k) Unipro
8
5.7. Technological comparison
Table 2: Basic Unit Characteristics Comparison Table
9
Tenscare Ltd., Traditional 510(k)
Unipro
10
Table 3: Comparison of output specifications
| | New Device
UniPro | Predicate Device
Ultima NEO | Comparison |
|------------|----------------------|--------------------------------|------------|
| 510(k) No. | K232441 | K120054 | / |
11
| Waveform | TENS/EMS: | TENS/EMS | |
|---|---|---|---|
| TENS/EMS: | |||
| Symmetrical | |||
| Rectangular | Bi-phase Symmetrical | ||
| Rectangular | No substantial | ||
| difference - | |||
| Waveforms are not | |||
| substantially different | |||
| in TENS and | |||
| Microcurrent | |||
| Asymmetrical | |||
| Rectangular | |||
| Mono-Phase | |||
| Symmetrical | |||
| Rectangular | rectangular Microcurrent | ||
| Bi-Polar programs. Ultima | |||
| NEO consists of three | |||
| additional waveforms | |||
| in TENS program. | |||
| Microcurrent: | |||
| continuous | |||
| square unipolar | |||
| sawtooth unipolar | |||
| Symmetrical balanced | |||
| wave | Microcurrent: | ||
| Symmetrical | |||
| Rectangular | Both comply with | ||
| IEC 60601-1 | |||
| requirements. | |||
| rectangular | |||
| IFT: | |||
| Symmetrical balanced | |||
| wave | IFT: | ||
| Symmetrical balanced sine | |||
| wave | Identical-Waveforms | ||
| are identical in IFT | |||
| and EMS programs. | |||
| Maximum Output | |||
| Voltage (V) | TENS/EMS: | ||
| 54V@500Ω | |||
| 114 V@2 kΩ | |||
| 116 V@10 kΩ | TENS/EMS: | ||
| 73.6V@500Ω | |||
| 120V@2 kΩ | |||
| 124V@10 kΩ | No substantial | ||
| difference. | |||
| TENS/EMS and MIC | |||
| voltage values are | |||
| lower than Ultima | |||
| NEO. | |||
| Both comply with | |||
| IEC 60601-1 | |||
| requirements. | |||
| The difference in | |||
| voltage is | |||
| proportional to the | |||
| current ( Since the | |||
| resistance is the same | |||
| in both product | |||
| V=IxR). | |||
| Therefore, poses no | |||
| further risk or safety | |||
| concerns. | |||
| Microcurrent: | |||
| 0.4V@500Ω | |||
| 1.56 V@2 kΩ | |||
| 7.8 V@10 kΩ | Microcurrent: | ||
| 0.54V@500Ω | |||
| 2.12V@2 kΩ | |||
| 10.2V@10 kΩ | |||
| IFT: | |||
| 24V@500Ω | |||
| 34.4 V@2 kΩ | |||
| 40 V@10 kΩ | IFT: | ||
| 17V@500Ω | |||
| 30V@2 kΩ | |||
| 32 V@10 kΩ | |||
| Maximum Output | |||
| Current (mA) | TENS/EMS: | ||
| 108mA@500Ω (200μs) | |||
| 80mA @500Ω (400μs) | |||
| 57mA@2 kΩ | |||
| 11.6 mA@10 kΩ | TENS/EMS: | ||
| 147mA@500Ω | |||
| 60mA@2 kΩ | |||
| 12.4mA@10kΩ | No substantial | ||
| difference. | |||
| Unipro features an | |||
| amplitude | |||
| modulation mode, in | |||
| which waveforms are | |||
| pre-modulated. | |||
| Microcurrent: | Microcurrent: | ||
| 1.08mA@500Ω | |||
| 0.8mA@500Ω | 1.06mA@2 kΩ | Unipro MIC | |
| 0.78 mA @2 kΩ | 1.02mA@10kΩ | amplitude of 0.8mA | |
| is significantly | |||
| smaller than Ultima | |||
| Neo and therefore | |||
| poses no further risk | |||
| or safety concerns. | |||
| Both comply with | |||
| IEC 60601-1 | |||
| requirements. | |||
| 0.78 mA @10 kΩ | IFT/Amplitude Modulation: | ||
| IFT: | |||
| 48mA@500Ω | |||
| 17.2mA@2 kΩ | |||
| 4mA@10 kΩ | 34mA@500Ω | ||
| 15mA@2 kΩ | |||
| 3.2mA@10kΩ | |||
| Pulse Width (µs) | TENS: 50-300 µs | ||
| EMS: 100-400 µs | |||
| Microcurrent: 10-200ms | |||
| IFT: 125 µs | TENS/EMS: 50-400µs | ||
| Microcurrent: 2-200ms | |||
| IFT:120-125µs | No substantial | ||
| difference. Unipro | |||
| TENS/EMS and IFT | |||
| pulse width range are | |||
| within recommended | |||
| output, both comply | |||
| with IEC 60601-2-10. | |||
| Frequency(Hz) | TENS: 2-150Hz | ||
| EMS: 10-120Hz | |||
| Microcurrent: 0.5Hz, 1Hz, | |||
| 1.5Hz, 2Hz, 3Hz, 4Hz, 5Hz to | |||
| 50Hz | |||
| IFT: 2-160Hz (Carrier | |||
| Frequency: 4000Hz fixed | |||
| (CH1)) | TENS/EMS:1-150Hz | ||
| Microcurrent: 1-150Hz | |||
| IFT:4000-4160Hz | No substantial | ||
| difference. | |||
| The higher frequency | |||
| offered by Ultima | |||
| NEO may not provide | |||
| any additional benefit | |||
| in treatment. | |||
| frequency is still | |||
| within the | |||
| recommended range. | |||
| Both comply with | |||
| IEC 60601-2-10. | |||
| Net Charge (µC per | |||
| pulse) | 0.3µC@ 500 Ω | 0.4µC@ 500 Ω | No substantial |
| difference - | |||
| The Charge output is | |||
| dependent on current | |||
| and only used to set | |||
| the pulse width, | |||
| therefore variation is | |||
| irrelevant to | |||
| treatment. | |||
| Charge per pulse | |||
| (µC) = pulse width | |||
| (ms) x | |||
| current (mA). | |||
| Both comply with | |||
| IEC 60601-1 | |||
| requirements. |
Tenscare Ltd., Traditional 510(k)
Unipro
12
13
| Maximum
Phase
Charge, (μC) | TENS/ EMS: | TENS/ EMS: | No substantial
difference. |
|--------------------------------------|-----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 22.76μC@500Ω
Microcurrent:
160μC@500Ω
IFT:
2.8μC@500Ω | 21.62μC@500Ω
Microcurrent:
220.8μC@500Ω
IFT:
5.16μC@500Ω | Charge per pulse
(μC) = pulse width
(ms) x
current (mA);
The Charge is used to
set the pulse width,
therefore variation is
irrelevant to
treatment.
Both comply with
IEC 60601-1
requirements. |
| Maximum Current
Density, (mA/cm²) | TENS/EMS:
0.8mA/cm²@500Ω
Microcurrent:
0.008mA/cm²@500Ω
IFT:
0.82mA/cm²@500Ω | TENS/ EMS:
5.88mA/cm²@500Ω
Microcurrent:
0.022mA/cm²@500Ω
IFT:
1.65mA/cm²@500Ω | No substantial
difference - both
comply with IEC
60601-1
requirements. |
| Maximum Power
Density, (W/cm²) | TENS/ EMS:
0.0076 W/cm2
Microcurrent:
0.0001049 W/cm2
IFT | TENS/ EMS:
0.0086W/cm²(150Hz)
Microcurrent:
0.012W/cm²(150Hz)
IFT: | No substantial
difference - both
comply with IEC
60601-1
requirements |
Rationale for equivalence claim:
The Unipro and the specified equivalent device are intended to combine TENS, IFT, EMS and MIC technologies to assist with management of a range of conditions (as appropriate to the selected technology), including chronic , acute, and post-operative pain as well as muscle training, toning, bulking and reeducation.
The devices have a near-identical principle of operation, all involving the administration of the device onto the skin at anatomical locations suitable for the identified clinical problem. All technologies within the devices are extremely well-established in the market and neither the technologies nor their combination in a single device is novel. As will be demonstrated through the information presented in this section, these devices could be used interchangeably for performing the target procedure.
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5.8. Labeling comparison:
Unipro labeling is substantially equivalent to the predicate device, Ultima NEO label.
Summary of Technological Characteristics Compared to the Predicate Devices 5.9
Transcutaneous Electrical Nerve Stimulation (TENS), Electrical Muscle Stimulation (EMS), Microcurrent (MIC) and Interferential (IF) system are the technological principles for both the Unipro and the predicate device.
The subject and predicate device are based on the following same technological elements:
- . The new device Unipro is a portable electrotherapy device which combines four systems: Transcutaneous Electrical Nerve Stimulation (TENS), Electrical Muscle Stimulation (EMS), Microcurrent (MIC) and Interferential (IF), into one enclosure. These four systems work separately. When one system is working, the others do not work and thus do not affect each other. This feature has been fully guaranteed by the design. The marketed device Ultima NEO is also a portable electrotherapy device which combines four systems: Transcutaneous Electrical Nerve Stimulation (TENS), Electrical Muscle Stimulation (EMS), Microcurrent (MIC) and Interferential (IF), into one enclosure. These four systems work separately. When one system is working, the others do not work and thus do not affect each other. This feature has been fully guaranteed by the design.
- . The new device Unipro combines the systems of TENS and EMS into one package. It is also substantial equivalent to the marketed device Ultima NEO, their features and performances in muscle stimulation as well as pain relief therapy are substantially equivalent.
- The designed circuitry of TENS and EMS modes in the new device Unipro is almost the same as . the marketed device Ultima NEO. For the TENS and EMS systems, they are very similar in terms of circuit diagrams and same working principle; the marketed device Ultima NEO combines the Microcurrent (MIC) and Interferential (IF) systems into one package, but these systems are worked separately which is same in the Unipro.
- The marketed device Ultima NEO is a device which includes the Microcurrent stimulation system. . Microcurrent stimulation can be generated by a very low and relatively long period current. The specification of microcurrent system in Ultima NEO is very similar to that of Unipro MIC system.
15
- . The marketed device Ultima NEO is an interferential stimulator which generates the real-sine waves of electrical current. The specification of Ultima NEO is very similar to that of Unipro IF svstem.
- The new device Unipro is designed and combined the Interferential (IF) and Micro-current (MIC) . systems based on the design of Ultima NEO.
- The new device Unipro is of the same ranges of parameters as those of marketed device Ultima . NEO.
- . The software of the new device Unipro can be divided into four parts: the first for TENS system, the second for EMS system, the third for MIC system, and the four one for IF system. First of all, the part of software for TENS system of the new device Unipro is only a subset of that of the marketed device Ultima NEO. Secondly, the considerations on safety, effectiveness and reliability in Ultima NEO are also introduced into the EMS system of the new device; While the part of software for EMS system of the new device Unipro is almost the same as that of the marketed device Ultima NEO, by applying almost the same control methods for muscle contractionrelaxation. In other word. the TENS and EMS systems of the new device Unipro are almost the same as those of the marketed device Ultima NEO. Thirdly, the part of software for Microcurrent (MIC) system of the new device Unipro is very similar to that of the marketed device Ultima NEO. For the last, the part of software for Interferential (IF) system of the new device Unipro is very similar to that of the marketed device Ultima NEO.
- The accessories of the new device Unipro are similar to those of Ultima NEO, the marketed device. ●
- Both the new device Unipro and the marketed device Ultima NEO are passed the same tests of . applicable recognized international consensus standards.
Summary of Non-Clinical Performance Testing as Basis for Substantial Equivalence 5.10
Unipro has undergone extensive bench testing to provide evidence that its mechanical, electrical and software properties are substantially equivalent to the predicate devices, Ultima NEO (K120054). Both Subject and Predicate devices are provided non-sterile, have comparable operations and technology. The design of Unipro does not introduce any new risks.
Summary of Clinical Testing as Basis for Substantial Equivalence 5.11
No clinical testing was considered necessary.
16
Tenscare conducted a formal review of published research and clinical evaluation on the use of TENS, EMS, IFT and MC in pain relief for chronic, acute, or post-operative pain as well as muscle training, toning, bulking and re-education to establish evidence of the safety and effectiveness of these settings for this Indicated Use and electrode positions.
5.12 Conclusions
TensCare Ltd considers Unipro to be substantially equivalent to the predicate device Ultima NEO (K120054). This conclusion is based upon the devices' similarity in principles of operation, technology, materials, biological, clinical characteristics as well as indications for use.
Any identified differences between the Unipro and equivalent device are minor and of no consequence to safety or performance; most differences are based on commercial decisions and/or are intended to optimise patient comfort and user experience without altering efficacy. Access to data is sufficient to provide the manufacturer with sufficient information about the equivalent devices to support an equivalence claim, since the main data required to form a claim of equivalence relates to technical aspects of the devices (which are technical settings and performance parameters, details of which are available in the public domain) and other information (such as indications/contraindications and mode of action) which are also available in the public domain.
Therefore, the information submitted to the FDA for the Unipro does not raise new questions about safety or effectiveness and demonstrates with reasonable assurance based on stablished controls that the device is at least as safe and effective as a legally marketed device.