(56 days)
No
The device description and performance studies focus on standard electrical stimulation technology with pre-set programs and adjustable intensity controlled by buttons. There is no mention of AI or ML in the text.
Yes
The intended use of the devices includes temporary relief of pain and stimulating muscles to improve performance, which are therapeutic functions.
No
This device is an electrical stimulator (TENS and EMS) designed for temporary pain relief and muscle performance improvement, which are therapeutic functions, not diagnostic ones.
No
The device description explicitly states it is a "portable device, battery powered" and sends electrical current via "electrodes applied on the skin," indicating it includes hardware components beyond just software.
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 R-C1, R-E1, and R-T1 devices are electrical stimulators that apply electrical current to the skin for pain relief (TENS) or muscle stimulation (EMS). They do not analyze samples taken from the body.
- Intended Use: The intended uses described are for temporary pain relief and muscle performance improvement, which are physical therapies, not diagnostic procedures.
- Device Description: The description clearly states the device sends electrical current through electrodes applied to the skin. There is no mention of analyzing biological samples.
Therefore, these devices fall under the category of physical therapy or pain management devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
R-C1 TENS and EMS Stimulator
TENS: This mode 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), and lower extremities (leg) due to strain from exercise or normal household work activities.
EMS: This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
R-E1 EMS Stimulator
This device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
R-T1 TENS Stimulator
This 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), and lower extremities (leg) due to strain from exercise or normal household work activities.
Product codes
NUH, NGX
Device Description
The RW Series A Electrical Stimulators, which includes models R-C1 TENS and EMS stimulator, R-E1 EMS stimulator and R-T1 TENS stimulator, are Transcutaneous Electrical Nerve Stimulator and muscle stimulator for pain relief and/or Electrical Muscle Stimulator. The stimulator sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin. The parameters of units are controlled by the press buttons. Its intensity level is adjustable according to the needs of patients.
The device unit of R-C1 was portable device, battery powered (6.0V DC) multi-function device offering both Transcutaneous Electrical Nerve Stimulator(TENS) and Powered Muscle Stimulator (EMS) qualities in one device.
The electrode size is 50*50mm, the manufacturer is Top-Rank Health care Equipment Co., Ltd. The electrode is OTC use and cleared with 510(K), the cleared number is K132588. It has been evaluated and tested according to ISO 10993-1/-5 and -10 standards.
The three models of R-C1, R-E1 and R-T1 have the same appearance, structure, display, electrical principle and CDF, the main differences are software and color. The R-C1 have TENS mode (18 programs), EMS mode (15 programs). The R-E1 only have EMS mode (15 programs) and R-T1 only have TENS mode (18 programs). The R-C1 was combination the function of R-E1 and R-T1.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A series of safety and performance tests were conducted on the subject device, RW series A Electrical stimulators (Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator and model R-T1 TENS Stimulator).
- Shelf life
- Software validation
- Electromagnetic compatibility and electrical safety
- Function test
All the test results demonstrate RW series A Electrical stimulators (Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator and model R-T1 TENS Stimulator) meets the requirements of its pre-defined acceptance criteria and intended uses, and is substantially equivalent to the predicate devices.
No clinical test data was used to support the decision of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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).
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
June 7, 2018
Shenzhen Roundwhale Technology Co., Ltd. Kevin Zhang General Manager No. 615, Building C of Sanlian Industrial Zone, Shiyan, Baoan District Shenzhen, GuangDong, CN 518108
Re: K180956
Trade/Device Name: Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: February 9, 2018 Received: April 12, 2018
Dear Kevin Zhang:
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. 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
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Vivek J. Pinto -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180956
Device Name
Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator
Indications for Use (Describe)
R-C1 TENS and EMS Stimulator
TENS: This mode 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), and lower extremities (leg) due to strain from exercise or normal household work activities.
EMS: This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
R-E1 EMS Stimulator
This device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
R-T1 TENS Stimulator
This 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), and lower extremities (leg) due to strain from exercise or normal household work activities.
Type of Use (Select one or both, as applicable)
| Research Use Only (Part 301 CFR 301.3: Select One) | For In-Vitro Use Only (Part 301 CFR 301.3: Select One) |
|---|---|
| ------------------------------------------------------------------------------------------ | ---------------------------------------------------------------------------------------------------------------- |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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Sponsor: Shenzhen Roundwhale Technology Co., Ltd File No: RW-Stimulator A-FDA-8 Date: Jun. 6, 2018
510(k) SUMMARY
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92.
The assigned 510(k) number is: K180956
1. Information of Submitter and Correspondent
Submitter's information:
| Company Name: | Shenzhen Roundwhale Technology Co., Ltd |
|---|---|
| Street Address: | No. 615, Building C of Sanlian Industrial Zone, Shiyan, Baoan District |
| City: | Shenzhen |
| State/ Province: | Guangdong |
| Country: | China |
| Telephone: | +86(755) 23212776 |
| Fax: | +86(755) 23212776 |
| Contact Person: | Kevin Zhang |
| Contact Title: | General Manager |
| Contact Email: | info@yjing.net |
Submission correspondent's information:
Shenzhen Reanny Medical Devices Management Consulting Co., Ltd
Address: Room 2012#, Gebu commercial building, Hongxing community, Songgang street, Baoan district, Shenzhen 518000, China
Contact Person: Reanny Wang; E-mail: reanny@reanny.com
2. Device Information
- a) Trade Name: R-C1, TENS and EMS Stimulator Common Name: Electro-Stimulator or Electrical Stimulator
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| Classification Name: | Stimulator, Muscle, Powered, for muscle conditioning
per 21 CFR § 890.5850;
Transcutaneous Electrical Nerve Stimulator for Pain Relief;
Stimulator, Nerve, Transcutaneous, Over-the-Counter
per 21 CFR § 882.5890 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Class: | Class II |
| Product Code: | NUH, NGX |
| b) Trade Name: | R-E1, EMS Stimulator |
| Common Name: | Powered Muscle Stimulator, OTC |
| Classification Name: | Stimulator, Muscle, Powered, for muscle conditioning
per 21 CFR § 890.5850; |
| Device Class: | Class II |
| Product Code: | NGX |
| c) Trade Name: | R-T1, TENS Stimulator |
| Common Name: | TENS or TENS Device |
| Classification Name: | Transcutaneous Electrical Nerve Stimulator for Pain Relief;
Stimulator, Nerve, Transcutaneous, Over-the-Counter
per 21 CFR § 882.5890 |
| Device Class: | Class II |
| Product Code: | NUH |
3. Identification of Predicate Device(s)
| Manufacturer | Shenzhen Dongdixin Technology Co., Ltd |
|---|---|
| Legally Marketed Device | MT9001, LT3060 |
| 510 (K) Number | K130802 |
4. Description of Device
The RW Series A Electrical Stimulators, which includes models R-C1 TENS and EMS stimulator, R-E1 EMS stimulator and R-T1 TENS stimulator, are Transcutaneous Electrical Nerve Stimulator and muscle stimulator for pain relief and/or Electrical Muscle Stimulator. The stimulator sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin. The parameters of units are controlled
5
by the press buttons. Its intensity level is adjustable according to the needs of patients.
The device unit of R-C1 was portable device, battery powered (6.0V DC) multi-function device offering both Transcutaneous Electrical Nerve Stimulator(TENS) and Powered Muscle Stimulator (EMS) qualities in one device.
The electrode size is 50*50mm, the manufacturer is Top-Rank Health care Equipment Co., Ltd. The electrode is OTC use and cleared with 510(K), the cleared number is K132588. It has been evaluated and tested according to ISO 10993-1/-5 and -10 standards.
The three models of R-C1, R-E1 and R-T1 have the same appearance, structure, display, electrical principle and CDF, the main differences are software and color. The R-C1 have TENS mode (18 programs), EMS mode (15 programs). The R-E1 only have EMS mode (15 programs) and R-T1 only have TENS mode (18 programs). The R-C1 was combination the function of R-E1 and R-T1.
5. Intended Use
R-C1, TENS and EMS Stimulator
For TENS mode
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
For EMS mode
To be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
R-E1, EMS Stimulator
To be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
R-T1, TENS Stimulator
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
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6. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
6.1 Non-clinical testing
A series of safety and performance tests were conducted on the subject device, RW series A Electrical stimulators (Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator and model R-T1 TENS Stimulator).
- Shelf life
- Software validation
- Electromagnetic compatibility and electrical safety
- Function test
All the test results demonstrate RW series A Electrical stimulators (Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator and model R-T1 TENS Stimulator) meets the requirements of its pre-defined acceptance criteria and intended uses, and is substantially equivalent to the predicate devices.
6.2 Clinical Testing
No clinical test data was used to support the decision of substantial equivalence.
7. Performance Summary
| Item | Description | FDA recognized
consensus
standards | Justification |
|--------------------------------|---------------------------------|------------------------------------------|---------------|
| Safety | IEC 60601-1:2005+
A1:2012 | Yes | Conform |
| EMC | IEC 60601-1-2:2014 | Yes | Conform |
| Home healthcare
environment | IEC 60601-1-11:2015 | Yes | Conform |
| Performance | IEC 60601-2-10:2012
+A1:2016 | Yes | Conform |
| Software | IEC 62304:2006 | Yes | Conform |
| Usability | IEC 62366-1:2015 | | |
| Risk management | ISO 14971:2007 | Yes | Conform |
The devices conform to applicable standards as follow table:
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8. Comparison for Predicate Device & Subject Device
The RW series A Electrical stimulators (Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator and model R-T1 TENS Stimulator) submitted in this 510(k) file is substantially equivalent in intended use, design, technology/ principles of operation, materials and performance to the cleared OTC Electrical stimulator models MT9001, LT3060 (K130802). Differences between the devices cited in this section do not raise any new issue of substantial equivalence.
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| Comparison
item | New device | | | Predicate device | | Substantial
equivalence
determination | |
|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| | R-C1TENS and EMS
Stimulator | R-E1 EMS
Stimulator | R-T1 TENS
Stimulator | MT9001 | LT3060 | | |
| 510K# | | Pending | | K130802 | | N/A | |
| Manufacturer | | Shenzhen Roundwhale Technology Co., Ltd. | | | Shenzhen Dongdixin Technology Co., Ltd | | N/A |
| Intended use | For TENS: This mode 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), and lower
extremities (leg) due to
strain from exercise or
normal household work
activities.
For EMS: This mode is
designed to be used for
stimulate healthy
muscles in order to
improve and facilitate
muscle performance. | This device is
designed to be
used for
stimulate
healthy muscles
in order to
improve and
facilitate muscle
performance. | This 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), and lower
extremities (leg)
due to strain
from exercise or
normal
household work
activities. | For TENS: This mode 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), and lower
extremities (leg) due to
strain from exercise or
normal household work
activities.
For EMS: This mode is
designed to be used for
stimulate healthy muscles
in order to improve and
facilitate muscle
performance. | 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), and lower
extremities (leg)
due to strain
from exercise or
normal
household work
activities. | Same | |
| Comparison item | | New device | | | Predicate device | | Substantial
equivalence
determination |
| | | R-C1TENS and
EMS Stimulator | R-E1 EMS
Stimulator | R-T1 TENS
Stimulator | MT9001 | LT3060 | |
| Prescription or OTC | | OTC | OTC | OTC | OTC | OTC | Same |
| FDA product code | | NUH, NGX | NGX | NUH | NUH, NGX | NUH | Same |
| Basic technological characteristics | | | | | | | |
| Power source | | Battery powered, d.c. 6.0V, 4 X AAA batteries | | | Battery powered, d.c.
9.0V, one 6F22 battery | | Different but does not
adversely impact
safety and
effectiveness of
subject device |
| User interface | | By LCD display | | | By LCD display | By LCD display | Same |
| Output channel | | Two channels | | | Two channels | | Same |
| Number of output models | | TENS and EMS | EMS | TENS | TENS and
EMS | TENS | Same |
| Number of treatment programs | | For TENS: 18
For EMS: 15 | 15 | 18 | For TENS: 4;
For EMS: 3 | ? | N/A |
| Number of
output channels | Synchronous
or
Alternating? | | Alternating | | Alternating | | Same |
| Number of output channels | | 2 | | | 2 | | Same |
| Method of channel isolation | | By electrical circuit and software | | | By electrical circuit and
software | | Same |
| Constant Current or Constant
Voltage? | | Constant current | | | Constant current | | Same |
| | New device | | | Predicate device | | Substantial
equivalence
determination | |
| Comparison item | R-C1TENS and
EMS Stimulator | R-E1 EMS
Stimulator | R-T1 TENS
Stimulator | MT9001 | LT3060 | | |
| Constant Current or Constant
Voltage? | Constant current | | | Constant current | | Same | |
| Waveform | Biphasic square | | | Biphasic square | | Same | |
| Software/Firmware/
Microprocessor Control? | Yes | | | Yes | | Same | |
| Automatic overload trip? | Yes | | | Yes | | Same | |
| Automatic Over Current Trip? | Yes | | | Yes | | Same | |
| Automatic No Load Trip? | Yes | | | Yes | | Same | |
| Automatic shut off? | Yes | | | Yes | | Same | |
| Patient Override Control? | Yes | | | Yes | | Same | |
| Indication
function | On/off status? | Yes | | Yes | | Same | |
| | Low battery? | Yes | | Yes | | Same | |
| | Voltage/ current
level? | Yes | | Yes | | Same | |
| Time range (min) | Nonadjustable 28, 30 and 32 minutes | | | 1-60 minutes | | Different but
does not
adversely impact
safety and
effectiveness of
subject device | |
| Comparison item | New device | | | Predicate device | | Substantial
equivalence
determination | |
| | R-C1TENS and EMS
Stimulator | R-E1 EMS
Stimulator | R-T1 TENS
Stimulator | MT9001 | LT3060 | | |
| Patient
Leakage
Current | - Normal
condition (uA)
11.4 uA | 11.4 uA | 11.4 uA | 0.61uA | | | |
| | - Single fault
condition (uA)
9.6uA | 9.6uA | 9.6uA | | 0.68uA | | |
| | Average DC current through
electrodes when device is on but
no pulses are being applied (uA) | TENS: N/A
EMS: 0
No output no
pulse applied | TENS: 0
EMS: N/A
No output no
pulse applied | TENS: 0
EMS: 0
No output no pulse
applied | | Same | |
| | Housing materials construction | Plastic (ABS) enclosure | | Plastic (ABS) enclosure | | Same | |
| | Treatment area | Any area
(Except those
treatment area
which been
described in the
user manual can
not use ) | Shoulder, waist,
back, neck,
upper
extremities(arm)
, Lower
extremities
(leg); | For TENS mode:
shoulder, waist, back,
neck, upper
extremities(arm), Lower
extremities (leg);
For EMS: Any area
(Except those treatment
area which been
described in the user
manual can not use ) | | Same | |
| | | | | | | | |
| | TENS: 0
EMS: 0
No output no pulse
applied | | | | | | |
| | Comparison item | New device | | | Predicate device | | Substantial
equivalence
determination |
| | | R-C1TENS and EMS
Stimulator | R-E1 EMS
Stimulator | R-T1 TENS
Stimulator | MT9001 | LT3060 | |
| | List of applied part material(s) | Electrode - silica gel | | | Electrode - silica gel | | Same |
| | Compliance with 21 CFR 898 ? | Yes | | | Yes | | Same |
| Classification | Type of protection
against electric shock | Internally powered equipment | | | Internally powered
equipment | | Same |
| | Degree of protection
against electric shock | Type BF applied part | | | Type BF applied part | | Same |
| | Device Class | Class II | | | Class II | | Same |
| Compliance
with
Voluntary
Standards? | Mechanical Safety | Compliant with requirements of IEC 60601-1, IEC 60601-2-10 safety standards | | | | | Same |
| | Electrical Safety | Compliant with requirements of IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2 safety
standards | | | | | Same |
| | Energy delivered | The delivered energy is limited according to requirements of collateral IEC 60601-2-10
safety standards | | | | | Same |
| | Other | Compliant with requirements of IEC 60601-11 safety standard | | | | | Same |
| | Applied part | Electrode pad | | | Electrode pad | | Same |
| | Weight (lbs., oz.) | 0.243 | | | 0.28 | | Slightly different
but does not
impact safety
and
effectiveness of
subject device |
| Comparison item | New device | | | Predicate device | | Substantial
equivalence
determination | |
| | R-C1TENS and
EMS Stimulator | R-E1 EMS
Stimulator | R-T1 TENS
Stimulator | MT9001 | LT3060 | | |
| Dimensions(in.) [W × H × D]
For unit | 4.82x2.78x1.08 | | | 4.5x2.55x0.9 | | Slightly different but
does not impact
safety and
effectiveness of
subject device | |
| Operating temperature and
humidity | 5°C40°C; 15%RH93%RH; | | | Unknowable | | Slightly different but
does not impact
safety and
effectiveness of
subject device | |
| Storage temperature and
humidity | -10°C55°C; 10%RH90%RH; | | | Unknowable | | | |
| Output Specifications | | | | | | | |
| Waveform | TENS mode | Biphasic | N/A | Biphasic | Biphasic | | Same |
| | EMS mode | Biphasic | Biphasic | N/A | Biphasic | | Same |
| Shape | TENS mode | Square | N/A | Square | Square | | Same |
| | EMS mode | Square | Square | N/A | Square | | Same |
| Maximum
output
voltage
(Vpp) | @500Ω | 30 | 30 | 30 | 48 | 48 | Different but does
not adversely |
| | @2KΩ | 108 | 108 | 108 | 100 | 114 | not adversely |
| | @10KΩ | 108 | 108 | 108 | 105 | 115 | impact safety and
effectiveness of
subject device |
| Max Output
Current (mA) | @500Ω | 60 | 60 | 60 | 96 | | Different but does |
| | @2KΩ | 54 | 54 | 54 | 50 | 57 | not adversely |
| | @10KΩ | 10.8 | 10.8 | 10.8 | 10.5 | 11.5 | impact safety and
effectiveness of
subject device |
| Comparison item | New device | | | Predicate device | | Substantial equivalence determination | |
| | R-C1TENS and
EMS Stimulator | R-E1 EMS
Stimulator | R-T1 TENS
Stimulator | MT9001 | LT3060 | | |
| Pulse Width Range(uS) | 100-380uS | 200-380uS | 100-330uS | 50-300uS | 50-300uS | Different but does not
adversely impact safety
and effectiveness of
subject device | |
| Frequency (Hz) | 1-125Hz | 1-110Hz | 2-125Hz | 1-150Hz | 1-150Hz | Different but does not
adversely impact safety
and effectiveness of
subject device | |
| For
multi-program
waveforms
only | Symmetrical
phases? | Yes | Yes | Yes | Yes | Same | |
| | Phase
Duration | 100-380uS | 200-380uS | 100-330uS | 50-300uS | 50-300uS | |
| Net Charge per pulse cycle
(uC, 500Ω) | 0 | 0 | 0 | 0 | 0 | Same | |
| Maximum Phase Charge
(uC, 500Ω) | 22.8 | 22.8 | 19.8 | | 0.0288 | | |
| Maximum Current Density
(mA/cm², 500Ω, r.m.s) | 2.4 | 2.4 | 2.4 | | 1.15 | Different but does not
adversely impact safety
and effectiveness of
subject device | |
| Max. average current (average
absolute value, mA) | 0.675 | 0.675 | 0.617 | | 4.32 | Different but does not
adversely impact safety
and effectiveness of
subject device | |
| Maximum Power Density
(W/cm², 500Ω, r.m.s) | 0.23 | 0.072 | 0.23 | | 0.373 | | |
| Comparison item | | New device | | | Predicate device | | Substantial
equivalence
determination |
| Burst mode
(i.e. pulse
trains) | Pulses per burst | 25 | N/A | 25 | 7 | N/A | Different but does
not adversely
impact safety and
effectiveness of
subject device |
| | Bursts per
second (Hz) | 2 | N/A | 2 | 0.5,
0.7,1,2,3,4,
5 | N/A | |
| | Burst duration | 250ms | N/A | 250ms | 70ms | N/A | |
| | Duty cycle | 500ms | N/A | 500ms | 35ms/
350ms | N/A | |
| On time (s) | | 0.5-12 | N/A | 0.5-12 | N/A | 1-30 | Similar and does
not impact safety
and effectiveness
of subject device |
| OFF time (s) | | 0.5-1 | N/A | 0.5-1 | N/A | 1-60 | and effectiveness
of subject device |
| Electrode area (cm²) | | 25 | 25 | 25 | 25 | 25 | Same |
| | | R-C1TENS and
EMS Stimulator | R-E1 EMS
Stimulator | R-T1 TENS
Stimulator | MT9001 | LT3060 | |
9
Image /page/9/Picture/0 description: The image shows the word "ROOVJOY" in white letters on a black background. The "O" in "ROOVJOY" is stylized with a red crescent shape that wraps around the letter. The font is bold and sans-serif. The logo is simple and modern.
10
Image /page/10/Picture/0 description: The image shows the word "ROOVJOY" in white letters on a black background. There is a red crescent shape that is behind the letters "OVJ". The font is sans-serif and the letters are bold. The logo is simple and modern.
11
Image /page/11/Picture/0 description: The image shows the word "ROOVJOY" in white letters on a black background. The "O" in "ROOVJOY" is replaced by a red crescent shape. The font is bold and sans-serif.
12
Image /page/12/Picture/0 description: The image shows the word "ROOVJOY" in white letters on a black background. There is a red crescent shape that curves around the letters "OVJ". The font is sans-serif and bold. The logo is simple and modern.
13
Image /page/13/Picture/0 description: The image shows the word "ROOVJOY" in white letters on a black background. The "O" in "ROOVJOY" is replaced by a red crescent shape. The crescent shape is open on the left side and curves around the top and right side of the "O".
14
Image /page/14/Picture/0 description: The image shows the word "ROOVJOY" in white letters on a black background. The letters are in a bold, sans-serif font. A red crescent shape is behind the "VJOY" portion of the word, adding a design element to the logo. The overall design is simple and modern.
15
Image /page/15/Picture/0 description: The image is a logo for ROOVJOY. The text "ROOVJOY" is in white, bold, sans-serif font. The letters are evenly spaced and of uniform size. A red crescent shape is behind the "VJOY" portion of the text. The background is black.
Similarity and Difference
The RW series A Electrical stimulators (Model R-C1 TENS and EMS stimulator and model R-T1 TENS Stimulator) has been compared with "OTC electrical stimulator Models MT9001, LT3060". The subject device has and principle of operation, similar technological chat predicate device. Although there are several specifications that are different between two devices, the comparison analysis has been completed to demonstrate that the differences between the served by the adversely impact the safety and effectiveness of the subject device has undergone safety and performance tests, and the results complied with the test requests. Therefore, the difference between the predicate device did not raise any problem of substantial equivalence. The subject device is substantially equivalent to the predicate devices in safety and performance claims.
9. Conclusions
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Image /page/16/Picture/0 description: The image shows the logo for ROOVJOY. The text "ROOVJOY" is in white, sans-serif font on a black background. A red, semi-circular shape is behind the "OJ" in the name, adding a design element to the logo.
After analyzing non-clinical laboratory studies and safety testing data, it can be concluded that the RW series A Electrical stimulators (Model R-C1 TENS and EMS stimulator and model R-T1 TENS Stimulator) is substantially equivalent to the predicate devices.