(237 days)
Not Found
No
The summary describes a device using RF and EMS technology with adjustable parameters, but there is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is intended for the treatment of selected medical conditions such as pain relief, muscle spasms, increasing local circulation, prevention of disuse atrophy, muscle re-education, and maintaining or increasing range of motion, which are all therapeutic purposes.
No
The device description focuses on its therapeutic capabilities, such as pain relief, muscle spasms treatment, local circulation increase, cellulite reduction, prevention of disuse atrophy, muscle re-education, and maintaining/increasing range of motion. There is no mention of the device being used to diagnose conditions or gather diagnostic information.
No
The device description explicitly mentions hardware components such as a power console, LCD monitor, electrodes, and the generation of electrical currents (RF and EMS), indicating it is a hardware-based medical device with potential software control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside the body.
- Device Function: The BACK 4 device uses RF and EMS technology to apply energy directly to the patient's body for therapeutic purposes (pain relief, muscle stimulation, cellulite reduction, etc.). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly describes treatment of medical conditions by applying energy to the body, not by analyzing biological samples.
- Device Description: The description details electrodes and applicators that are placed in contact with the patient, not equipment for handling and analyzing biological specimens.
Therefore, the BACK 4 device falls under the category of therapeutic medical devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The BACK 4 device employs RF technology or EMS technology for the treatment of selected medical conditions.
The BACK 4 device in RF mode is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation. The BACK 4 massage device is intended to provide a temporary reduction in the appearance of cellulite.
The BACK 4 device in EMS mode is intended for:
*Prevention or retardation of disuse atrophy
*Increasing local blood circulation
*Muscle re-education
*Maintaining or increasing range of motion.
The RF treatment mode and EMS mode should not be used in combination or sequentially.
Product codes (comma separated list FDA assigned to the subject device)
IPF, PBX
Device Description
The BACK 4 device generates high frequency sinusoidal current with a monopolar mode of application using two electrodes. A neutral electrode is placed in contact with the patient and a handheld active electrode is manipulated by a therapist. When both electrodes are in contact with a patient the electrical circuit is closed and RF therapy can be provided. The device can be operated in a capacitive or resistive monopolar modes and a multipolar mode.
The product consists of a power console, LCD monitor, and accessories including capacitive, resistive and multipolar electrodes. The unit can be adjusted to provide various levels of treatment frequency ranging from 300kHz to 1MHz.
The product can also employ EMS technology. It generates a 4kHz or 1.5kHz electrostimulation signal (modulated at a frequency set between 2Hz and 200Hz).
The two RF and EMS technologies should not be used in combination or sequentially.
An Emergency stop button feature allows the patient to shut down the unit in the event of any discomfort.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
All body, external part except eyes, mouth, heart, mucosa parts and brain area
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital or Clinic setting
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 technological characteristics of the BACK 4 System has of electical safety, performance, biocompatbility, software and usability.
The following testing has been conducted with satisfactory results:
- BACK4 Usability and Risk Management Usability and Risk Management assessments were done using worse-case assumptions to verify user interface, safety features and satisfactory performance.
- Biocompatibility: Samples of the tissue contacting probes were tested for cytotoxicity, sensitization and intracutaneous reactivity.
- Software Assessment: Software features were assessed in accordance with FDA software validation guidelines. Levels of Concern, User & System. Requirements, Hazard Analysis, Software Requirements, Architectural Design, Software Validation & Testing were all addressed.
- Electromagnetic Compatibility: EMC testing was done to evaluate emissions and immunity to electromage with IEC 60601-1-. 2.
- Electrical Safety: Full electrical safety testing was done in compliance with IEC 60601-1.
- Human being testing: a tissue temperature elevation study was conducted to demonstrate ability of all applicators of the RF mode of subject device to maintain therapeutic temperature on the human skin. The study was conduct on three different people on three body parts with all device operation modes and at the lowest and highest power settings. The skin and room temperatures were measured.
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.
BACK3 COLOR, K214090, Evolve System with the T3 Applicator, K210877
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 14, 2023
SWIMS America Corp Matthieu Commeau Managing Director 1133 Westchester Avenue Suite N 220 White Plains, New York 10604
Re: K230167
Trade/Device Name: BACK 4 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF. PBX Dated: August 17, 2023 Received: August 17, 2023
Dear Matthieu Commeau:
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. 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 located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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,
Jitendra V. Virani -S
CDR Jitendra Virani, MS, MBA Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230167
Device Name BACK 4
Indications for Use (Describe)
The BACK 4 device employs RF technology or EMS technology for the treatment of selected medical conditions.
The BACK 4 device in RF mode is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation. The BACK 4 massage device is intended to provide a temporary reduction in the appearance of cellulite.
The BACK 4 device in EMS mode is intended for:
- *Prevention or retardation of disuse atrophy
*Increasing local blood circulation
*Muscle re-education
*Maintaining or increasing range of motion.
The RF treatment mode and EMS mode should not be used in combination or sequentially.
| Type of Use (Select one or both, as applicable) |
|---|
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Premarket Notification SWIMS America Corp K230167 Section 1.5
510(k) Summary
Date : 09/13/2023
| 1. | Submitted By: | SWIMS America Corp
1133 Westchester Avenue Suite N 220
White Plains, NY 10604
Tel. 917-371-7388 |
|----|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Contact Person : | Mr. Matthieu COMMEAU
Managing Director of SWIMS America Corp
1133 Westchester Avenue Suite N 220
White Plains, NY 10604
Tel. 917-371-7388
Email : mat@winback.com |
| 3. | Common Name: | BACK4 Massager, Radiofrequency Induced Heat therapy and
Electrostimulation device |
| 4. | Trade Name : | BACK 4 |
| 5. | Regulation Number: | 21 CFR 890.5850 |
| 6. | Regulation Name: | Powered Muscle Stimulator |
| 7. | Device Product Codes: | IPF, PBX |
| 8. | Regulatory Class: | II |
| 9. | Predicate Devices: | Primary Predicate Device: BACK3 COLOR, K214090
Secondary Predicate Device: Evolve System with the T3
Applicator, K210877 |
Description:
The BACK 4 device generates high frequency sinusoidal current with a monopolar mode of application using two electrodes. A neutral electrode is placed in contact with the patient and a handheld active electrode is manipulated by a therapist. When both electrodes are in contact with a patient the electrical circuit is closed and RF therapy can be provided. The device can be operated in a capacitive or resistive monopolar modes and a multipolar mode.
The product consists of a power console, LCD monitor, and accessories including capacitive, resistive and multipolar electrodes. The unit can be adjusted to provide various levels of treatment frequency ranging from 300kHz to 1MHz.
The product can also employ EMS technology. It generates a 4kHz or 1.5kHz electrostimulation signal (modulated at a frequency set between 2Hz and 200Hz).
The two RF and EMS technologies should not be used in combination or sequentially.
4
An Emergency stop button feature allows the patient to shut down the unit in the event of any discomfort.
Intended Use:
The BACK 4 device employs RF technology or EMS technology for the treatment of selected medical conditions.
The BACK 4 device in RF mode is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation. The BACK 4 massage device is intended to provide a temporary reduction in the appearance of cellulite.
The BACK 4 device in EMS mode is intended for:
*Prevention or retardation of disuse atrophy
*Increasing local blood circulation
*Muscle re-education
*Maintaining or increasing range of motion.
The RF treatment mode and EMS mode should not be used in combination or sequentially.
Substantial Equivalence/Technological Characteristics:
The BACK 4 device is substantially equivalent to the following primary and secondary devices for the technology RF and EMS accordingly.
| Device | Manufacturer | 510(k) No. | Technical characteristics similar to the Subject device |
|---|---|---|---|
| Primary device | |||
| BACK3 COLOR | |||
| Product codes: PBX | Daeyang Medical | K214090 (SWIMS America Corp) | RF technology (300kHz-1MHz) |
| Secondary device | |||
| Evolve System with the T3 Applicator | |||
| Product codes : IPF, PBX, GZJ | InMode Ltd. | K210877 | EMS technology signals |
A Primary predicate device (RF technology)
The BACK 4 device is substantially equivalent to the BACK3 COLOR device from SWIMS America Corp which was cleared under premarket notification K214090. Both devices are cart mounted consoles with electrode accessories capable of operation in monopolar and multipolar modes in the range of 300kHz to 1MHz radiofrequency.
Both devices operate in the same treatment range and feature intensity adjustments from 0 to 100%. Electrical safety and biocompatibility have been established for both devices. No direct comparison was made since there are no significant differences in operation and test results indicate identical safety.
> Secondary predicate device (EMS technology)
The BACK 4 device shares also the same intended use and Product codes (PBX, IPF) as the FDA-Cleared Evolve System with the T3 Applicator (K210877). Both devices are also designed to deliver electro-muscle stimulation (EMS) for the treatment of different body areas for various medical
5
applications. These devices have the same range of frequencies (Subject Device: 2-200 Hz; Secondary Predicate: 3-200 Hz).
Indeed, both devices have specifications in common:
- A Main Line Frequency (nominal): 50-60 Hz
- Input Voltage (nominal): 100 240 VAC. A
Please note that the Subject device does not follow the Product code GZJ, which the secondary predicate does follow. That is why some intended uses linked to this Product Code are not found in the intended use of the Subject device: Symptomatic relief and management of chronic, intractable postsurgical acute pain.
These minor differences in technical specifications should not alter the device safety and effectiveness. Furthermore, the Subject device had underwent the required performance testing and validation testing and demonstrates its conformance with device design requirements and with applicable standards.
The safety features and compliance with safety standards of the subject device are similar to the safety features and compliance with safety standards of the predicate devices. All user-contacting materials were tested for biocompatibility and found to comply with the ISO 10993-1 standard. Furthermore, the design and development phases of the subject device were validated throughout a set of performance tests, including software validation testing, electrical and mechanical safety testing according to IEC 60601-1 standard, electromagnetic compatibility testing according to IEC 60601-1-2 standard, safety and essential performance of nerve and muscle stimulators testing according to IEC 60601- 2-10 standard.
All in all, these performance tests demonstrated that the device specifications meet the system requirements and do not raise new safety or effectiveness concerns.
Consequently, it can be concluded that the BACK 4 is substantially equivalent to its predicate device and can be sold in the US market.
The table below summarizes the equivalence of the devices.
Predicate Device Comparison Table
6
| SWIMS America Corp
| K230167 | ||||
|---|---|---|---|---|
| Element of | ||||
| Comparison | 510(k) Device: | |||
| BACK 4 | Primary Predicate Device: | |||
| BACK3 COLOR | ||||
| K214090 | Secondary Predicate Device: | |||
| Evolve System with the T3 | ||||
| Applicator | ||||
| K210877 | Explanation of Differences | |||
| Regulation and | ||||
| Product Classification | ||||
| Codes | 21 CFR 890.5850 (IPF) | |||
| 21 CFR 878.4400 (PBX) | 21 CFR 878.4400 (PBX) | 21 CFR 890.5850 (IPF) | ||
| 21 CFR 878.4400 (PBX) | ||||
| 21 CFR 882.5890 (GZJ) | The BACK 4 device follows the same Product | |||
| codes as the two predicate devices: PBX, IPF. | ||||
| However, BACK 4 does not use the code GZJ- | ||||
| Transcutaneous electrical nerve stimulator for | ||||
| pain relief. Therefore, BACK 4 does not have | ||||
| the indications for use of the GZJ Product Code. | ||||
| This does not raise new questions of safety and | ||||
| effectiveness. | ||||
| Prescription/OTC | Prescription | Prescription | Prescription | Identical |
| Indications for Use | The BACK 4 device employs RF | |||
| technology or EMS technology for the | ||||
| treatment of selected medical | ||||
| conditions. |
PBX code: The BACK 4 device in RF
mode is intended to provide topical
heating for the purpose of elevating
tissue temperature for the treatment of
selected medical conditions such as
relief of pain, muscle spasms, and
increase in local circulation.
The BACK 4 massage device is
intended to provide a temporary
reduction in the appearance of cellulite.
IPF code:
The BACK 4 device in EMS mode is
intended for:
*Prevention or retardation of disuse
atrophy
*Increasing local blood circulation
*Muscle re-education
*Maintaining or increasing range of
motion. | PBX code: The BACK3 COLOR
device is intended to provide topical
heating for the purpose of elevating
tissue temperature for the treatment
of selected medical conditions such
as relief of pain, muscle spasms, and
increase in local circulation.
The BACK3 COLOR massage
device is intended to provide a
temporary reduction in the
appearance of cellulite. | The Evolve System with the T3
Applicator employs RF
technology or EMS-TENS
technology for the treatment of
selected medical conditions.
PBX code:
The T3 Applicator in RF mode
is intended for the temporary
relief of minor muscles aches
and pain, temporary relief of
muscle spasm, and temporary
improvement of local blood
circulation.
IPF code:
The T3 Applicator in EMS
mode is intended for:
*Relaxation of muscle spasms
*Prevention or retardation of
disuse atrophy
*Increasing local blood
circulation
*Muscle re-education
*Maintaining or increasing
range of motion | The BACK 4 device shares the same intended
for use as BACK3 COLOR and Evolve System
for the RF technology (PBX code).
Also, the BACK 4 device has less indications
for use than Evolve System with the T3
Applicator for EMS-TENS modes.
Therefore, the BACK 4 device does not have
new indications for use compared to the two
predicate devices for RF and EMS
technologies. This does not raise new questions
of safety and effectiveness. |
7
510(k) Premarket Notification SWIMS America Corp K230167 The RF treatment mode and EMS mode *Immediate post-surgical stimulation of calf muscles to should not be used in combination or prevent venous thrombosis. sequentially. GZJ code: The T3 Applicator in TENS mode is intended for: *Symptomatic and management of chronic, intractable pain *Post-surgical acute pain *Post-trauma acute pain. The RF treatment mode and EMS/TENS mode should not be used in in combination or sequentially. Hospital or Clinic setting Environment Used Hospital or Clinic setting Hospital or Clinic setting Identical IEC 60601-1: General requirements IEC 60601-1: General requirements Performance IEC 60601-1: General The BACK 4 device complies to the same standards (FDA for basic safety and essential for basic safety and essential requirements for basic safety performance standards as the two predicate recognized consensus performance performance and essential performance devices, except to standards) IEC 60601-2-2 as the Subject device is not IEC 60601-1-2: General requirements IEC 60601-1-2: General IEC 60601-1-2: General intended to be used in a surgical environment for basic safety and essential requirements for basic safety and requirements for basic safety nor in an emergency. Also, the BACK 4 device performance - Collateral Standard: essential performance - Collateral and essential performance is not a life supporting device. This does not Electromagnetic disturbances -Standard: Electromagnetic Collateral Standard: raise new questions of safety and effectiveness. Requirements and tests. disturbances - Requirements and Electromagnetic disturbances tests. Requirements and tests. IEC 60601-2-10: particular IEC 60601-2-10: particular requirements for the Basic Safety and IEC 60601-2-10: particular Essential Performance of Nerve and requirements for the Basic Safety requirements for the Basic Muscle stimulators. and Essential Performance of Nerve Safety and Essential and Muscle stimulators. Performance of Nerve and IEC 60601-1-6: General requirements Muscle stimulators. for basic safety and essential IEC 60601-1-6: General performance -Collateral standard: requirements for basic safety and IEC 60601-1-6: General Usability. essential performance -Collateral requirements for basic safety standard: Usability. and essential performance -Collateral standard: Usability.
8
| 510(k) Premarket Notification | |||||
|---|---|---|---|---|---|
| SWIMS America Corp | |||||
| K230167 | |||||
| EN IEC 60601-2-2 :Particular | |||||
| requirements for the basic safety | |||||
| and essential performance of | |||||
| high-frequency surgical | |||||
| equipment and high-frequency | |||||
| surgical accessories. | |||||
| Applicator Shapes | Square, rectangular and circular | Square, rectangular and circular | Rectangular | Identical to the primary predicate device. | |
| Difference in shape compared to the secondary | |||||
| predicate device. However, this difference | |||||
| does not raise any new questions of safety and | |||||
| effectiveness compared to the secondary | |||||
| predicate device. The biocompatibility testing | |||||
| and usability attest of the safety of these | |||||
| accessories. | |||||
| Infrared Light | No | No | No | Identical | |
| Vacuum (suction) | No | No | No | Identical | |
| Applied energy | RF/EMS | RF | RF/EMS-TENS | The BACK 4 device has the same RF | |
| technological characteristics as the primary | |||||
| predicate device. | |||||
| The subject device can apply the same energy | |||||
| EMS as the secondary predicate device. | |||||
| However, the BACK 4 does not use GZJ as the | |||||
| secondary predicate device does. So, the | |||||
| subject device does not have TENS energy. | |||||
| This does not raise new questions of safety and | |||||
| effectiveness. | |||||
| Power source | Main line frequency (nominal): 50- | ||||
| 60Hz. | |||||
| Input Voltage (nominal): | |||||
| 100- | |||||
| 240VAC. | |||||
| Input current (rms): 1.25Aac | |||||
| @240Vac and 3Aac @ 100Vac. | Main line frequency (nominal): 50- | ||||
| 60Hz. | |||||
| Input Voltage (nominal): | |||||
| 100- | |||||
| 240VAC. | |||||
| Input current (rms): 1.25Aac | |||||
| @240Vac and 3Aac @ 100Vac. | Main line frequency (nominal): | ||||
| 50-60Hz. | |||||
| Input Voltage (nominal): 100- | |||||
| 240VAC. | |||||
| Input current (rms): 4A. | Power source characteristics are identical to the | ||||
| primary predicate device. | |||||
| The power source characteristics are different | |||||
| to those of the secondary predicate device. The | |||||
| main line frequency and input voltage are | |||||
| similar, except for the input current. However, | |||||
| this difference does not raise new safety and | |||||
| effectiveness questions as electrical safety | |||||
| testing has been performed following state of | |||||
| the art standards. | |||||
| RF Type | Multipolar/Unipolar | Multipolar/Unipolar | Multipolar/Unipolar | Identical | |
| RF Frequency | 300kHz – 1MHz | 300kHz – 1MHz | 1MHz | Identical to the Primary predicate device for RF | |
| technology. | |||||
| The RF frequency of the secondary device falls | |||||
| within range of the subject device. | |||||
| This difference does not raise any new | |||||
| questions of safety and effectiveness compared | |||||
| to the secondary predicate device. | |||||
| Maximum RF output | |||||
| Power | 300W | 300W | 75W | Identical to the primary predicate device. | |
| Different from the secondary predicate device. | |||||
| However, this difference does not raise new | |||||
| questions of safety and effectiveness. RF output | |||||
| power has already been cleared with the | |||||
| primary predicate device. | |||||
| Electrical type | Type BF | Type BF | Type BF | Identical | |
| EMS output | |||||
| specifications; | |||||
| waveform | Biphasic with symmetrical waveform | N.A | Symmetrical | ||
| Biphasic waveform | Identical | ||||
| EMS Frequency | 2 to 200Hz | N.A | 3 to 200 Hz | Not identical. | |
| The EMS frequency range of the subject device | |||||
| has minor difference to the secondary predicate | |||||
| device. | |||||
| This difference does not raise any new | |||||
| questions of safety and effectiveness compared | |||||
| to the secondary predicate device. | |||||
| This characteristic does not apply to the | |||||
| primary predicate device. | |||||
| Patient Leakage | |||||
| Current -Normal | |||||
| Condition (uA) |