(225 days)
No
The summary describes a standard TENS/EMS device with adjustable output and a compliance timer. There is no mention of AI, ML, or any features that would suggest adaptive learning or data-driven decision making beyond basic programmable settings.
Yes
The device is intended for pain relief, muscle spasm relaxation, increasing blood circulation, and preventing disuse atrophy, all of which are therapeutic applications.
No
The device is described as a TENS and EMS device used for pain relief, muscle stimulation, and other therapeutic purposes, not for diagnosing medical conditions.
No
The device description clearly states it is a combination TENS and EMS device that delivers electrical current through electrodes and has physical components like output channels, jacks, and a battery pack. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a TENS and EMS device for therapeutic purposes (pain relief, muscle stimulation, etc.). IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details an electrical stimulator that applies current to electrodes on the patient's skin. This is a direct interaction with the patient's body, not the analysis of a biological specimen.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, the Flex-MT + is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
TENS - Transcutaneous Nerve Stimulation
- Symptomatic relief of chronic intractable pain
- Post traumatic and post surgical pain relief
EMS - Electrical Muscle Stimulation
- Relaxation of muscle spasm
- Increasing local blood circulation
- Muscle re-education
- Prevention or retardation of disuse atrophy
- Prevention of venous thrombosis of the calf muscles immediately after surgery
- Maintaining or increase range of motion
Product codes
IPF, GZJ
Device Description
The Flex-MT + is a combination TENS and EMS device which delivers nerve or muscle stimulation by applying an electrical current to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the intended treatment of patient. The stimulator has 2 output channels, accessed through jacks at the top of the housing, so that it may stimulate either 2 or 4 patient electrodes. The device is powered by 700 mAh 4.8V Ni-MH rechargeable battery pack. A patient compliance timer can memorize 60 sets of operation records; the total recordable time is 999 hours.
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
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)
The Flex-MT + is compliant with the following standards and has outputs which are within the same range as the predicate devices.
- IEC 60601-1:2005 = Corr 1:2006, Corr 2:2007 Medical Electrical Equipment - Part 1: General Requirements For Safety
- IEC 60601-1-2:2007/AC:2010 Medical Electrical Equipment - Part 1-2: General Requirements For Safety - Collateral Standard: Electromagnetic Compatibility -Requirements And Test
- IEC 60601-2-10 Edition 2.0 2012-06 Medical electrical equipment -- Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
- IEC 60601-1-11:2010 Medical electrical equipment -- Part 1-11: General requirements . for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- EN 60601-1-4:1996+A1:1999 Medical device Programmable Electrical Medical Systems (PEMS);
- EN 62304 : 2006/AC:2008 Medical device software-Software life cycle processes.
Clinical Data: No clinical study data is provided in support of this submission.
Based on the Flex-MT+ and the predicate device technical characteristics, performance, and indications for use, the substantially equivalent to the EMSI Flex MT and the EMPI 300V. As detailed in the tables above, the differences between the subject and predicate devices do not adversely impact the FlexMT+ safety and effectiveness for it's substantial equivalence to the predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K083030 EMSI TENS-EMS-14 (Flex MT), K021100 EMPI 300 PV
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked slightly offset from each other. The profiles are connected by a flowing line that forms the base of the design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 7, 2014
EMSI % Cherita James M Squared Associates, Inc. 815 King St. Suite 206 Alexandria, VA 22314
Re: K140467
Trade/Device Name: Flex-MT+ Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: IPF, GZJ Dated: August 20, 2014 Received: August 22, 2014
Dear Ms. James:
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 requirements, including, but not limited to: registration and listing (21
1
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 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Felipe Aquel -S
- Carlos L. Peña, Ph.D., M.S. for 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) K140467
Device Name Flex-MT +
Indications for Use (Describe)
TENS - Transcutaneous Nerve Stimulation
- · Symptomatic relief of chronic intractable pain
· Post traumatic and post surgical pain relief
EMS - Electrical Muscle Stimulation
- · Relaxation of muscle spasm
- Increasing local blood circulation
- · Muscle re-education
- · Prevention or retardation of disuse atrophy
- · Prevention of venous thrombosis of the calf muscles immediately after surgery
- · Maintaining or increase range of motion
Type of Use (Select one or both, as applicable)
| Registration Use (Part 21 CFR 201.Subpart D) | Over-The-Counter Use (21 CFR 201.Subpart C) |
|---|---|
| --------------------------------------------------------------------------- | -------------------------------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(K) SUMMARY
The following information is provided as required by 21 CFR § 807.92 for EMSI's Flex-MT + 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the information upon which the substantial equivalence determination is based.
- Sponsor: EMSI 3504 Cragmont Dr. Suite#100 Tampa, Florida 33619 Ph: 813-471-0129 Fax: 813-471-0130 Registration Number: 3003573572
M Squared Associates, Inc. Contact: Cherita James 815 King Street, Suite 206 Alexandria, VA 22314 Ph. 703-562-9800 Ext 257 Fax. 703-562-9797
| Date of Submission: | September 30, 2014 |
|---|---|
| Proprietary Name: | Flex-MT + |
| Common Name: | Powered Muscle Stimulator, Transcutaneous Nerve Stimulator |
| Regulatory Class: | II |
| Regulation: | 21 CFR 890.5850, 21 CFR 882.5890 |
| Panel: | Physical Medicine |
| Product Codes: | IPF, GZJ |
| Predicate Device(s): | K083030 EMSI TENS-EMS-14 (Flex MT), K021100 EMPI 300 PV |
The Flex-MT + is a combination TENS and EMS device which delivers Device Description: nerve or muscle stimulation by applying an electrical current to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the intended treatment of patient. The stimulator has 2 output channels, accessed through jacks at the top of the housing, so that it may stimulate either 2 or 4 patient electrodes. The device is powered by 700 mAh 4.8V Ni
4
MH rechargeable battery pack. A patient compliance timer can memorize 60 sets of operation records; the total recordable time is 999 hours.
Intended Use: As prescribed by a physician for the following:
TENS- Transcutaneous Nerve Stimulation
- Symptomatic relief of chronic intractable pain .
- . Post traumatic and post surgical pain relief
EMS- Electrical Muscle Stimulation
- . Relaxation of muscle spasm
- . Increasing local blood circulation
- . Muscle re-education
- . Prevention or retardation of disuse atrophy
- Prevention of venous thrombosis of the calf muscles immediately after surgery
- . Maintaining or increase range of motion
Performance Testing
The Flex-MT + is compliant with the following standards and has outputs which are within the same range as the predicate devices.
- . IEC 60601-1:2005 = Corr 1:2006, Corr 2:2007 Medical Electrical Equipment - Part 1: General Requirements For Safety
- . IEC 60601-1-2:2007/AC:2010 Medical Electrical Equipment - Part 1-2: General Requirements For Safety - Collateral Standard: Electromagnetic Compatibility -Requirements And Test
- IEC 60601-2-10 Edition 2.0 2012-06 Medical electrical equipment -- Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
- IEC 60601-1-11:2010 Medical electrical equipment -- Part 1-11: General requirements . for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- EN 60601-1-4:1996+A1:1999 Medical device Programmable Electrical Medical Systems (PEMS);
- . EN 62304 : 2006/AC:2008 Medical device software-Software life cycle processes.
5
Technical and Performance Comparison
Both the subject device and the predicate device are battery powered, handheld devices with similar unit characteristics including device controls, power supply, output modes and channels, waveforms, output voltage, current and pulse durations, as well as device material.
| | Subject Device
Flex-MT + | Predicate K08303
EMSI TENS-
EMS-14(Flex MT) | Predicate
K021100
EMPI 300PV
(TENS/NMES
modes) | Comment |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Indication for Use | TENS-
Transcutaneous
Nerve Stimulation
•Symptomatic
relief of chronic
intractable pain
•Post traumatic
and post surgical
pain relief
EMS- Electrical
Muscle
Stimulation
•Relaxation of
muscle spasm
•Increasing local
blood circulation
•Muscle re-
education
•Prevention or
retardation of
disuse atrophy
•Prevention of
venous
thrombosis of the
calf muscles
immediately after
surgery
•Maintaining or
increase range of
motion | TENS-
Transcutaneous
Nerve Stimulation
•Symptomatic
relief of chronic
intractable pain
•Post traumatic and
post surgical pain
relief
EMS- Electrical
Muscle Stimulation
•Relaxation of
muscle spasm
•Increasing local
blood circulation
•Muscle re-
education
•Prevention or
retardation of
disuse atrophy
•Prevention of
venous thrombosis
of the calf muscles
immediately after
surgery
•Maintaining or
increase range of
motion | TENS-
Transcutaneous
Nerve Stimulation
•Symptomatic
relief of chronic
intractable pain
•Adjunctive
treatment for post
surgical and post
trauma pain
EMS- Electrical
Muscle Stimulation
•Relaxation of
muscle spasm
•Increasing local
blood circulation
• Re-education
muscles
• Retarding or
preventing disuse
atrophy
•Prevention of
venous thrombosis
of the calf muscles
immediately after
surgery
•Maintaining or
increase range of
motion | Same indications
in the subject and
predicates TENS
and NMES modes. |
| | Subject Device
Flex-MT + | Predicate K08303
EMSI TENS-
EMS-14(Flex
MT) | Predicate
K021100
EMPI 300PV | Comment |
|------------------------------------------------------------------------------------------|---------------------------------------------------------|----------------------------------------------------------|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 4. Power Source | 700 mAh 4.8V
Ni-MH,
rechargeable | four batteries, size
AA, alkaline | Two batteries, size
AA rechargeable,
and charger | All devices are
battery operated.
The subject and |
| | Subject Device
Flex-MT + | Predicate K08303
EMSI TENS-
EMS-14(Flex
MT) | Predicate
K021100
EMPI 300PV | Comment |
| | battery pack and
charger | | | EMPI devices
offer a battery
charger. |
| – Method
of Line Current
Isolation | n/a | n/a | n/a | NA |
| - Patient
Leakage Current
- Normal condition
- Single
fault condition | not measurable