(291 days)
Not Found
No
The document describes a pre-programmed electrical muscle stimulator with user-adjustable settings. There is no mention of AI, ML, or any learning or adaptive capabilities based on data.
No
The document explicitly states that "Mini, Model EC12-01 is not intended to be used as a therapy for any medical condition." and "Unlike the classified powered muscle stimulator devices intended for use in physical medicine and rehabilitation, this device is not intended for use in patients with medical conditions and is intended only for muscle conditioning purposes."
No
The device is described as a powered muscle stimulator intended to stimulate healthy muscles for performance improvement, not for diagnosing any medical condition.
No
The device description explicitly states it is a "9 volt battery powered hand-held device, with detachable electrodes," indicating it is a hardware device that is software-driven, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a "powered muscle stimulator" that applies electrical current to the skin to stimulate muscles. It works externally on the body.
- Intended Use: The intended use is for "stimulating healthy muscles in order to improve or facilitate muscle performance." This is a physical function, not a diagnostic test on a biological sample.
- Lack of Diagnostic Language: The text does not mention any analysis of biological samples, detection of biomarkers, or diagnosis of medical conditions.
Therefore, the Mini, Model EC12-01 falls under the category of a physical therapy or muscle conditioning device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Mini . Model EC12-01 is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.
Mini Model EC12-01 is not intended to be used as a therapy for any medical condition. None of the Mini Masseuse programs are designed for injured or ailing muscles and their use on such muscles is contraindicated.
Mini, Model EC12-01 is intended for use by healthy persons to apply transcutaneous electrical muscle stimulation(EMS) through skin contact electrodes. Indications for use are as follows:
Mini is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. Mini is not intended to as a therapy for any medical condition. Please read the indications, precautions and warnings carefully to determine whether any of them apply to you.
Mini stimulates action potentials in the motor nerves supplying muscle. Different patterns of muscle activity can be imposed on the target muscle, depending on the timing and intensity of the stimulation signal. Mini contains programs for exercise warm-up, muscle performance improvement and exercise recovery.
Product codes (comma separated list FDA assigned to the subject device)
NGX
Device Description
The Mini is a powered muscle stimulator for muscle conditioning. It is a device used for other than medical purposes to apply an electrical current to electrodes on a person's skin to temporarily affect the stimulated muscle's contractile properties, force output, and/or fatique resistance. Unlike the classified powered muscle stimulator devices intended for use in physical medicine and rehabilitation, this device is not intended for use in patients with medical conditions and is intended only for muscle conditioning purposes.
The Mini is a 9 volt battery powered hand-held device, with detachable electrodes. The electrodes are placed over the muscles which are to be stimulated. The muscles are excited by electric pulses which are created by an electronic circuit. This circuit is software driven, to the user can adjust the stimulation. Mini is pre-programmed with 6 stimulation programs. Programs duration varies depending on the selected mode, which can be reduced by user inputs.
The case of the device is made of ABS plastic. Unit dimensions are . 120mm x 60mm x 32mm (L x W x H).
- There is an LCD display on the face for user information.
- . Five keys on the face of the device permit user inputs.
- Two electrode inputs are located on the device. Electrodes and . leads are supplied as accessories to the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
muscles
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthy persons
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)
Mechanical, environmental safety and performance testing have been accomplished according to the table below to demonstrate this product is substantially equivalent to the predicate device. The submitted device passed all of these tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).
0
510(k) Summary
| Submitter's References |
|---|
| MJ Specialty Retail |
| 5198 NORTH US HWY 65 |
| WALNUT SHADE, MO |
| Post code: 65771 |
| Tel: (417)561-1216 |
| Fax: (417)561-1218 |
| Official Correspondent |
| Mr. Leiping Wang |
| No. 56, Luoming South Road, Guanhaiwei |
| Town, Cixi |
| Zhehang, Ningbo, China 65771 |
| Tel: (417)561-1216 |
| Fax: 86-574-63671001 |
| Summary Contents |
| • Submitted Device |
| • Device Description |
| • Statement of Intended Use |
| • Technological Equivalence |
| • Safety |
| • Effectiveness |
| • Conclusions |
1
1. Submitted Device
| Trade Name | Mini |
|---|---|
| Common Name | Sport Muscle Stimulator |
| Classification Name | Power Muscle Stimulator |
1.1. Predicate/Legally Marketed Device
| Model | Manufacturer | K Number | Submitted Device |
|---|---|---|---|
| SLENDERTONE | |||
| ENERVIVE, | |||
| MODEL 561 | BIO-MEDICAL | ||
| RESEARCH | |||
| CORP. | K071666 | Mini , Model EC12_01 | |
| TOP-RANK | |||
| ADHESIVE | |||
| ELECTRODE | TOP-RANK | ||
| HEALTH CARE | |||
| EQUIPMENT CO., | |||
| LTD. | K070612 | Accessory Electrodes to | |
| Mini |
1.2. Proposed Indications
The proposed indications for the predicate Slendertone 561 and the submitted Mini EC12-01 are the same. The design, stimulation energy, stimulation times, stimulation frequency and intended use are exactly the same.
Mini is intended for used by healthy persons to apply transcutaneous electrical muscle stimulation(EMS) through skin contact electrodes. Indications for use are as follows:
Mini is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. Mini is not intended to as a therapy for any medical condition. Please read the indications, precautions and warnings carefully to determine whether any of them apply to you.
Mini stimulates action potentials in the motor nerves supplying muscle. Different patterns of muscle activity can be imposed on the target muscle, depending on the timing and intensity of the stimulation signal. Mini contains programs for exercise warm-up, muscle performance improvement and exercise recovery.
2
2. Device Description
Image /page/2/Picture/2 description: The image shows an advertisement for the "Mini Model EC12-01", an electronic stimulation unit. The advertisement claims the unit uses copyright-protected ultra-smooth, deep tissue feeling sensations similar to technology used exclusively by chiropractors, physical therapists, and sports trainers around the world. The advertisement also states that the unit is available in three colors. The image shows three of the units.
3
2.1 Description :
The Mini is a powered muscle stimulator for muscle conditioning. It is a device used for other than medical purposes to apply an electrical current to electrodes on a person's skin to temporarily affect the stimulated muscle's contractile properties, force output, and/or fatique resistance. Unlike the classified powered muscle stimulator devices intended for use in physical medicine and rehabilitation, this device is not intended for use in patients with medical conditions and is intended only for muscle conditioning purposes.
The Mini is a 9 volt battery powered hand-held device, with detachable electrodes. The electrodes are placed over the muscles which are to be stimulated. The muscles are excited by electric pulses which are created by an electronic circuit. This circuit is software driven, to the user can adjust the stimulation. Mini is pre-programmed with 6 stimulation programs. Programs duration varies depending on the selected mode, which can be reduced by user inputs.
2.2 Structure
The case of the device is made of ABS plastic. Unit dimensions are . 120mm x 60mm x 32mm (L x W x H).
- There is an LCD display on the face for user information. ●
- . Five keys on the face of the device permit user inputs.
- Two electrode inputs are located on the device. Electrodes and . leads are supplied as accessories to the device.
2.3 Electronics and Software
Electronics
The functions of the Mini are driven by a CMOS chip, which has a Flash ROM to accommodate the programming. The chip is programmed to deliver pulses to the electronic circuit, corresponding to the 6 stimulation programs. User interface inputs are input into the chip via the interface buttons on the face of the device. The user can manipulate the program, intensity and time duration of the stimulation. Digital signals are sent to the chip and the program responds to the variable inputs. The output of the stimulator is limited by programming and the electronic circuit design. The device is not capable of delivering harmful levels of energy. Software
Programming for the device is done in Assembly language on the CMOS chip. The program was tested and validated for proper operation.
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4
3. Statement of Intended Use
Mini . Model EC12-01 is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.
Mini Model EC12-01 is not intended to be used as a therapy for any medical condition. None of the Mini Masseuse programs are designed for injured or ailing muscles and their use on such muscles is contraindicated.
Mini, Model EC12-01 is intended for use by healthy persons to apply transcutaneous electrical muscle stimulation(EMS) through skin contact electrodes. Indications for use are as follows:
Mini is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. Mini is not intended to as a therapy for any medical condition. Please read the indications, precautions and warnings carefully to determine whether any of them apply to you.
Mini stimulates action potentials in the motor nerves supplying muscle. Different patterns of muscle activity can be imposed on the target muscle, depending on the timing and intensity of the stimulation signal. Mini contains programs for exercise warm-up, muscle performance improvement and exercise recovery.
3.1 Training Programs
PROGRAM AND OBJECTIVE
EC12-01 has two programs for muscle performance improvement, as well as programs for exercise preparation and post-exercise active recovery. Depending on your objective your objective, you may select the appropriate program as follows:
| Objective | Program number | Intensity Range | Duration |
|---|---|---|---|
| Exercise Preparation | Mode 1 | 1-10 | 12 |
| Active Recovery 1 | Mode 2 | 1-10 | 30 |
| Active Recovery 2 | Mode 3 | 1-10 | 20 |
| Active Recovery 3 | Mode 4 | 1-10 | 20 |
| Build Endurance | Mode 5 | 1-10 | 20 |
| Build Strength | Mode 6 | 1-10 | 20 |
Page 5 of 11
5
Mode 1: Build Endurance (20 Min.)
This program gently warms up the muscles prior to exercise. It uses a technique called ""twitch potentiation" to prepare muscle fibers for exercise. It feels like a rhythmic massage. Increase the intensity unit you get a strong, but comfortable muscle movement.
Mode 5: Build Endurance (20 Min.)
This program uses a low frequency pulse train which favors twitch fibers. It develops their aerobic capacity and capillary supply and thereby exercises. The exercise comprises an alternating sequence of work and rest and deep muscle contraction. Do not exceed your comfort level.
Mode 6: Muscle Strengthening(20 Min.)
This program uses a pulse frequency appropriate to fast twitch muscle fibers It develops their aerobic capacity and is used for improving maximum muscle strength. The exercise comprises a sequence of work phases separated by longer relaxation phases. Increase the stimulation intensity until you get a strong and deep contraction. Do not exceed your comfort level.
Mode 2: Active Recovery 1 (30 Min.)
This program produces muscle twitches at very low frequency and it feels like a tapping massage. This stimulates blood flow and helps speed up the removal of lactic acid as it accelerates the exchange between the blood supply and the muscle fibers. As a result, the muscles recover more quickly from fatigue, becoming more relaxed with reduced stiffness. Use it after intense exercise to promote recovery and relaxation.
Mode 3: Active Recovery 2 (20Min.)
This 20-minute program is similar to Active Recovery 1 except that the muscle twitch rate slows down during the session. It feels like a tapping massage, but softer than Active Recovery 1.
Mode 4: Active Recovery 3 (20 Min.)
This from of stimulation activates the muscle in a rhythmic motion in a short contraction/relaxation cycle. It feels like a kneading massage and is smoother than the other active recovery programs.
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6
4. Substantial Equivalence
The submitted Mini EC12-01 is constructed to perform like the predicate Slendertone 561. Both devices have six modes of operation and deliver the same electrical stimulation. The electrical stimulation delivered is alike in pulse frequency, voltage amplitude, pulse width, ramp-up/ramp-down, contraction time, relaxation time, times of stimulation and both have the same claimed effects from the stimulation.
| Items | EC12-01 | MODEL561
(K071666) | Discussion |
|------------------|------------------------|--------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Mode/Function | 6 | 6 | Same.
Basing on the above comparison and
detailed description, the subject
device's 6 mode is totally same as the
predict device's mode Program1-6; |
| Duration | 12-30Mins | 12-30Mins | Same. |
| Intensity Range | 1-10
(No sub-level) | 1-99
(subdivided
into 10 for
each 110,99) | Similar but all matching standards.
so total 1
According to the IEC60601-2-10,
each stepped voltage and current
does not exceed 10%, the highest
and lowest values should less than
2%. The EC12-01 classified the
intensity 110 according to the10 but
standards, the predict device is same
as the EC12-01, has 1
subdivided each into 10, so total
1~99. According to the standards, the
intensity's safety and effectiveness for
both devices is same. |
| Trigger Function | No | Yes | The predicate device has trigger
function, when key it without release,
into contraction cycle; but release it,
into relaxation cycle. The EC12-01
has no this function. |
| Output Channels | 1 | 2 | Although the number is different, but
the two channel of predict device are
same, all are synchronous, so the
output has the same effect. |
| Intend for Use | EMS | EMS | Same.
EMS (electrical muscle stimulation).
Intend to stimulate healthy muscles in
order to improve or facilitate muscle
performance. |
| Waveform | Biphasic | Biphasic | Same. |
| | | | |
Page 7 of
7
K110057
| Items | EC12-01 | MODEL561
(K071666) | Discussion |
|----------------------------------------------|-------------------|-----------------------|-----------------------------------------------|
| Shape | Rectangular | Rectangular | Same. |
| Net Charge per pulse | 0mC | 0mC | Same. |
| Positive Pulse Width | 200-300us | 200-300us | Same. |
| Negative Pulse Width | 200-300us | 200-300us | Same. |
| Interphase interval | 100us | 100us | Same. |
| Regulated Current | Yes | Yes | Same. |
| Microprocessor
Control | Yes | Yes | Same. |
| Automatic Shut Off | Yes | Yes | Same. |
| Patient Override
Control | No | No | Same. |
| Compliance with 21
CFR 898 | Yes | Yes | Same. |
| Battery | 1X9V 6F22 | 1X9V 6F22 | Same. |
| Electrodes /Pads | 60x50mm | 85x50mm | Different, but do not exceed safety
limit. |
| Weight (gram) | 87gram | 90gram | Weight different |
| Dimensions (in.)
[W x H x D] | 2.4' x 4.7' x1.3' | 2.4'x3.9' x1.2' | Dimensions different. |
| Housing Materials and
Construction | ABS plastic | ABS plastic | Same. |
| Low power indication
when lower than 3.3V | Yes | Yes | Same. |
| Lock function | Yes | Yes | Same. |
Page & of II
8
| Time countdown | -------------------------------------------------------------------------------------
Yes | Yes. | Same. |
|----------------|----------------------------------------------------------------------------------------------|------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | Value Career
MALE A BREAK A FREE A |
| Items | EC12-01 | MODEL561
(K071666) | Discussion |
|-------------------------------|---------|-----------------------|-------------------------------------------------|
| Indication of current
mode | Yes | Yes | Same. |
| Indication of Voltage | No | Yes | EC12-01 does not have indication of
voltage. |
| intensity bar | Yes | Yes | Same. |
| pad contact indicator | Yes | Yes | Same. |
| pause | Yes | Yes | Same. |
Differences
As noted in the table above, the EC12-01 has ten (10) levels of intensity, and the predicate has 99 levels. Both devices deliver from 0- 40V and 0-80mA. The predicate has control that is more precise in the range of control, but both deliver the same energy for stimulation. This does not constitute a safety or effectiveness difference.
The Slendertone 561 has 2 output channels, while the submitted Mini EC12-01 has a single channel of output. This difference does not constitute a difference in safety or effectiveness. This simply means the predicate device can deliver stimulation to two areas at a time, while the submitted device can deliver stimulation to one at a time.
9
5. Performance and Safety Testing
Mechanical, environmental safety and performance testing have been accomplished according to the table below to demonstrate this product is substantially equivalent to the predicate device. The submitted device passed all of these tests.
| no. | Serial Number/version | Standard and description |
|---|---|---|
| 1 | IEC 60601-1 | Medical electrical equipment - Part 1: |
| General requirements for safety | ||
| 2 | IEC 60601-1-2 | Medical electrical equipment - Part 1-2: |
| General requirements for safety - Collateral | ||
| standard: Electromagnetic compatibility - | ||
| Requirements and tests | ||
| 3 | IEC 60601-2-10 | Medical electrical equipment - Part 2-10: |
| Particular requirements for the safety of | ||
| nerve and muscle stimulators | ||
| 4 | ISO10993-5 | Biological Evaluation Of Medical Devices - |
| Part 5: Tests For Cytotoxicity: In Vitro | ||
| Methods | ||
| 5 | ISO10993-10 | Biological Evaluation Of Medical Devices - |
| Part 10: Tests For Irritation And Delayed- | ||
| Type Hypersensitivity | ||
| 6 | Guidance Document for | |
| Powered Muscle Stimulator | ||
| 510(k)s | FDA Guidance document for Powered | |
| Muscle Stimulators |
Page 10 of 11
10
6 Conclusions:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification The MJ Specialty Retail. Mini ,Model EC12_01is substantially equivalent to the predicate device as described herein.
Page 11 of 11
11
Image /page/11/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird, with its wings spread and head facing to the right. The bird is composed of three curved lines that suggest feathers or wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 2 8 2011
MJ Specialty Retail % IRC Mr. Charles Mack 77325 Joyce Way Echo, Oregon 97826
Re: K110057
Trade/Device Name: Mini Model EC12 01 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: NGX Dated: October 21, 2011 Received: October 25, 2011
Dear Mr. Mack:
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 micleading.
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 advine can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
12
Page 2 - Mr. Charles Mack
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its to!!-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Eunice Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
13
Indications for Use
510(k) Number (if known):
Device Name: Mini, Model EC12-01
Indications For Use:
Mini, Model EC12-01 is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.
Mini, Model EC12-01 is not intended to be used as a therapy for any medical condition. None of the Mini programs are designed for injured or ailing muscles and their use on such muscles is contraindicated.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KI10057 510(k) Number .
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