(166 days)
Not Found
No
The description focuses on user-controlled parameters and standard electrical muscle stimulation technology. There is no mention of adaptive algorithms, learning from data, or any other characteristic indicative of AI/ML.
Yes
The intended use states the device is "intended to stimulate healthy muscles in order to improve or facilitate muscle performance." While it specifies it's not for "therapy or treatment of medical conditions," stimulating muscles to improve performance falls under the general scope of therapeutic devices that aim to restore, improve, or maintain physiological function. Medical devices intended for muscle stimulation often have therapeutic indications. The Rx-only classification further supports its status as a medical/therapeutic device.
No
The FastFit EMS System is intended to stimulate healthy muscles to improve or facilitate muscle performance. It is a therapy device (stimulator), not a diagnostic device, as it does not diagnose medical conditions.
No
The device description clearly outlines multiple hardware components including the FastFit Exercise Suit with embedded electrodes and wiring, the EMS Controller, and a Power Adaptor, in addition to the software application.
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 perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- FastFit EMS System Function: The FastFit EMS System is described as a device that stimulates healthy muscles using electrical pulses delivered through electrodes embedded in a suit. Its intended use is to improve or facilitate muscle performance.
- Lack of Biological Sample Testing: The description makes no mention of collecting or analyzing any biological samples from the user. The device directly interacts with the user's muscles through electrical stimulation.
Therefore, the FastFit EMS System falls under the category of a physical therapy or muscle stimulation device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The FastFit EMS System is intended to simulate healthy muscles in order to improve or facilitate muscle performance.
It is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of the stimulation programs or operational parameters are designed to target injured or ailing muscles and its use on such muscles is contraindicated.
The FastFit EMS System is Rx only.
Product codes
NGX
Device Description
The EMS System is a series of electrical muscle stimulation (EMS) electrodes embedded in a compression textile body suit intended to be worn by a user during physical exercise. When operated, the device provides localized electrical muscle stimulation (EMS) pulses to major muscle groups at controllable intensities. When operated, the device provides localized EMS pulses to major muscle groups at controllable intensities. The FastFit EMS system consists of the following primary components:
- FastFit Exercise Suit
- EMS Controller
- Power Adaptor
- FastFit Software Application
The FastFit Exercise Suit is a full body compression garment made from a Nylon/Spandex stretch fabric that incorporates embedded electrodes over key muscle groups. These electrodes are constructed of a conductive fabric sewn over a foam pad. Each electrode is connected via an integrated set of wiring leads sewn into the suit fabric that connect to a central contact pad at the right hip of the suit. A suit-to-controller connector at the central contact pad has 10 pairs of pins that act as lead contacts. Once connected to the suit, the EMS controller can deliver EMS pulses at the programmed intervals.
EMS pulse intensity and target locations are controlled via a Bluetooth connection with a user's smartphone installed with the FastFit software application. A graphic user interface displayed on the touchscreen of the smartphone allows for the user to customize the stimulation program parameters at their discretion. After stimulation parameters have been set by the user with the software application, the parameters are uploaded to the EMS controller, and stimulation can be started anytime at the discretion of the user. The EMS controller is powered by a rechargeable lithium ion battery. A separate with an AC power adapter is provided to recharge the EMS controller when not in use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
major muscle groups
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Rx only.
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)
Comprehensive design verification and validation testing was performed on the FastFit EMS system. Results from bench and animal testing demonstrated that the function, performance, and safety of the device meet its intended use. Testing performed included a combination of the following:
- System Design Verification Testing ●
- Software Verification and Validation ●
- Electrical Safety Testing (IEC 60601-1, IEC 60601-1-11, IEC 60601-1-6, IEC 60601-2-10) ●
- . Electromagnetic Compatibility Testing (IEC 60601-1-2)
- Biocompatibility Testing (ISO 10993-1, ISO 10993-5, and ISO 10993-10) ●
- Usability/Human Factors Testing
Overall, testing confirmed that the FastFit EMS system can be used according to its intended use and in an equivalent manner to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Compex® Wireless USA (K143551), Katalyst Mark 1 Muscle Stimulation System (K181199)
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 22, 2020
Fast Fit LLC % Sigi Caron Regulatory Consultant Biologics and Medical Device Consulting Group 20370 Skyhawk Lane Topanga, CA 90290
Re: K192161
Trade/Device Name: FastFit EMS System Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: October 24, 2019 Received: October 24, 2019
Dear Sigi Caron:
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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 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.
For Vivek Pinto, Ph.D. Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192161
Device Name FastFit EMS System
Indications for Use (Describe)
The FastFit EMS System is intended to simulate healthy muscles in order to improve or facilitate muscle performance.
It is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of the stimulation programs or operational parameters are designed to target injured or ailing muscles and its use on such muscles is contraindicated.
The FastFit EMS System is Rx only.
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
1. 510(K) SUMMARY
This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| DATE PREPARED | August 6, 2019 |
|---|---|
| APPLICANT | Fast Fit LLC |
| 450 Park Avenue | |
| 31st Floor | |
| New York, NY 10022 | |
| OFFICIAL | |
| CORRESPONDENT | Sigi Caron, MBA RAC |
| Biologics and Medical Device Consulting Group | |
| 20370 Skyhawk Lane | |
| Topanga, CA 90290 | |
| Tel: (310) 455-3473 | |
| Fax: (888) 295-1535 | |
| sigi@BioMDG.com | |
| TRADE NAME | FastFit EMS System |
| COMMON NAME | Stimulator, Muscle Powered, for Muscle Conditioning |
| DEVICE CLASSIFICATION | Name: Powered Muscle Stimulator |
| Regulation No: 21 CFR §890.5850 | |
| Product Code: NGX - Stimulator, Muscle Powered, for | |
| Muscle Conditioning | |
| Class: II | |
| PREDICATE DEVICE | Compex® Wireless USA (K143551) |
| Katalyst Mark 1 Muscle Stimulation System (K181199) |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The EMS System is a series of electrical muscle stimulation (EMS) electrodes embedded in a compression textile body suit intended to be worn by a user during physical exercise. When operated, the device provides localized electrical muscle stimulation (EMS) pulses to major muscle groups at controllable intensities. When operated, the device provides localized EMS pulses to major muscle groups at controllable intensities. The FastFit EMS system consists of the following primary components:
- FastFit Exercise Suit
- EMS Controller
- Power Adaptor
- FastFit Software Application
4
The FastFit Exercise Suit is a full body compression garment made from a Nylon/Spandex stretch fabric that incorporates embedded electrodes over key muscle groups. These electrodes are constructed of a conductive fabric sewn over a foam pad. Each electrode is connected via an integrated set of wiring leads sewn into the suit fabric that connect to a central contact pad at the right hip of the suit. A suit-to-controller connector at the central contact pad has 10 pairs of pins that act as lead contacts. Once connected to the suit, the EMS controller can deliver EMS pulses at the programmed intervals.
EMS pulse intensity and target locations are controlled via a Bluetooth connection with a user's smartphone installed with the FastFit software application. A graphic user interface displayed on the touchscreen of the smartphone allows for the user to customize the stimulation program parameters at their discretion. After stimulation parameters have been set by the user with the software application, the parameters are uploaded to the EMS controller, and stimulation can be started anytime at the discretion of the user. The EMS controller is powered by a rechargeable lithium ion battery. A separate with an AC power adapter is provided to recharge the EMS controller when not in use.
INDICATIONS FOR USE:
The FastFit EMS System is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.
It is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the stimulation programs or operational parameters are designed to target injured or ailing muscles and its use on such muscles is contraindicated.
The FastFit EMS System is Rx only.
SUBSTANTIALLY EQUIVALENT TO:
The FastFit EMS System is substantially equivalent in intended use and technological features to two other commercially available powered muscle stimulator systems:
BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:
The FastFit EMS system is substantially equivalent to the listed predicate devices with respect to their indications for use (intended use) and technical characteristics. The following table compares the features of the proposed device and its predicates.
5
| Element | New Device:
FastFit EMS System | Primary Predicate:
Compex Wireless USA | Secondary Predicate:
Katalyst Mark 1 Muscle
Stimulation System Model 2 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | --- | K143551 | K181199 |
| Indications for Use | The FastFit EMS system "is
intended to stimulate
healthy muscles in order to
improve or facilitate muscle
performance.
It is not intended to be used
in conjunction with therapy
or treatment of medical
diseases or medical
conditions of any kind."
None of the stimulation
programs or operational
parameters are designed to
target injured or ailing
muscles and its use on such
muscles is contraindicated."
The FastFit EMS system is
Rx only. | The Compex Wireless USA
is an Over-The-Counter
device "intended to
stimulate healthy muscles
in order to improve or
facilitate muscle
performance." It is to be
used by adults only. The
Compex Wireless USA is
"not intended for
adjunctive therapy in the
treatment of medical
diseases and conditions of
any kind." None of the
Compex Wireless USA
stimulation programs are
designed for injured or
disease afflicted muscles. Its
use on such muscles is
contraindicated. The work
imposed on the muscles by
the Compex Wireless USA
electrical impulses allow the
triggering of action
potentials of motoneurones
are transmitted to the
muscle fibers via the motor
endplate where they
generate mechanical muscle
fiber responses that
correspond to muscle work.
Depending on the
parameters of the electrical
impulses (pulse frequency,
duration of contraction,
duration of rest, total
session duration, different
types of muscle work can be
imposed on the simulated
muscles.
The Compex Wireless USA
may therefore be considered
a technique of muscle
training. | The Katalyst Mark 1 "is
intended to stimulate healthy
muscles in order to improve
or facilitate muscle
performance.
It is not intended to be used
in conjunction with therapy
or treatment of medical
diseases or medical
conditions of any kind."
None of the training programs
or operational parameters are
designed to target injured or
ailing muscles and its use on
such muscles is
contraindicated."
The Katalyst Mark 1 is Rx
only. |
6
| Element | New Device:
FastFit EMS System | Primary Predicate:
Compex Wireless USA | Secondary Predicate:
Katalyst Mark 1 Muscle
Stimulation System Model 2 |
|-------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| | | Device Features | |
| Connection of device to
electrodes | The EMS controller is
connected via a cable
electrode harness directly to
the electrode pads. | Stimulation Module is
directly connected to the
custom Compex female
SNAP assembled in the
electrode. | The Katalyst Impulse Pack
unit is connected via a cable
electrode harness directly to
the electrodes. |
| Power Source | EMS Controller Module:
Rechargeable 3.7[V] / ≥
1800[mAh] LiPo battery | Remote: : Rechargeable
3.7[V] / ≥ 1500[mAh] LiPo
battery
Stimulation Modules:
Rechargeable 3.7[V] / ≥
450[mAh] LiPo battery | Li-Po rechargeable battery
3.8V, 7.79Wh
(2050mAh) |
| Charging System | AC/DC 5[v] 2.0 [A];
Distributed through docking
station | AC/DC 5[v] 3.5[A];
Distributed through docking
station to remote and 4
modules | AC/DC wall plug in,
distributed directly to the
device. 18.0[v], 1.33[A] |
| Method of line current
isolation | N/A (battery operated
device) | N/A (battery operated
device) | N/A (battery operated device) |
| Patient Leakage
Current
-Normal Condition
-Single Fault
Condition | N/A (battery operated
device) | N/A (battery operated
device) | N/A (battery operated device) |
| Number of Output
Modes | One (NMES) | One (NMES) | One |
| Number of Output
Channels
-Synchronous or
alternating? | 10
alternating
(never 2 channels activated
at the same time) | 4
Synchronous, but never 2
channels activated at the
same time | 10
Not publicly available |
| Method of Channel
Isolation | Each channel is the middle
of a H-Bridge. Except when
it is activated, each channel
is always in high impedance
state. | Each channel is the middle
of a H-Bridge. Except when
it is activated, each channel
is always in high impedance
state. | Not publicly available |
| Regulated Current or
Regulated Voltage? | Regulated current (all
channels) | Regulated current (all
channels) | Not publicly available |
| Electrode Integrated
into a body suit? | Yes | No. Placement of electrodes
is dictated by the operator. | Yes |
| Number of Electrodes | 2 per channel,
4 per channel on each arm
and on each leg;
Max 20 | Not publicly available | Only 2 per channel; Max 20 |
7
| Element | New Device:
FastFit EMS System | Primary Predicate:
Compex Wireless USA | Secondary Predicate:
Katalyst Mark 1 Muscle
Stimulation System Model 2 |
|-----------------------------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Electrode Leads
Compliant with 21 CFR
898? | Yes | Yes | Yes |
| Electrode Interface | 10mm magnetic buttons | Not publicly available | 4mm Standard SNAP
Connector |
| Wireless
Communication with
Control Interface | Yes. Uses Bluetooth Smart
(BT LE 4.0) | Not publicly available | Yes. Uses Bluetooth Smart
(BT LE 4.0) |
| Mobile / Form Factor | Yes (smartphone, stim
device attached to suit, and
wearable suit) | Not publicly available | Portable with difficulty, no
mobile device, its intended
use requires a Katalyst
certified operator. |
| Channel Control
Interface | Touch user interface
provided by FastFit
application on smartphone. | Not publicly available | Using rotary encoder knobs
for each channel and master
rotary encoder for all
channels |
| Instant Shutoff | Physical Button | Not publicly available | Physical Button |
| Software / Firmware /
Microprocessor
Control? | Yes | Yes | Yes |
| Automatic Overload
Trip? | Yes | Yes | Yes |
| Automatic No-Load
Trip? | No | Yes | No |
| Automatic Shutoff? | Yes | Yes | Yes |
| Patient Override
Control? | Yes | Yes | No |
| Interface Indicator
Display:
-On/Off Status | Yes (on remote and module
units) | Yes | Yes (on Impulse Pack via
LED and in application) |
| -Low Battery | Yes | Yes | Yes (on Impulse Pack) |
| -Voltage/Current
Level | Yes (on smartphone) | Yes | Yes (in application) |
| -Charging | Yes | Yes | Yes (on Impulse Pack) |
| -Duration of training | Yes (on smartphone) | Yes | Yes (in application) |
| Timer Range in Minutes | Maximum = 120 minutes | Maximum = 48 minutes | Maximum = 20 minutes |
| Weight | Controller Module: 505 g
EMS Suit: 695 g | Remote: 119 g
Stimulation Module: 2x60 g
Docking Station: 800 grams | Not publicly available |
8
| Element | New Device:
FastFit EMS System | Primary Predicate:
Compex Wireless USA | Secondary Predicate:
Katalyst Mark 1 Muscle
Stimulation System Model 2 |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Dimensions | Controller Module:
11.7x8.9x4.8 cm | Remote: 9x4.5x0.7 cm
Stimulation Module: 6.5x2
cm
Docking Station: 25x25x2
cm | Not publicly available |
| Housing Materials and
Construction | Nylon, Spandex
Polyester w/ Conductive
Coating | Not publicly available | Not publicly available |
| | | Output Specifications | |
| Waveform | Symmetrical Biphasic | Symmetrical Biphasic | Symmetrical Biphasic |
| Shape | Rectangular | Rectangular | Rectangular |
| Maximum Output
Voltage (±10%) | 35 V @500 Ω
95 V @ 2 kΩ
96 V @ 10 kΩ | 60 V @ 500 Ω
180 V @ 2 kΩ
180 V @ 10 kΩ | 60 V @ 500 Ω
96 V @ 2 kΩ
114.2 V @ 10 kΩ |
| Maximum Output
Current (±10%) | 70 mA @500 Ω
47.5 mA @ 2 kΩ
9.6 mA @ 10 kΩ | 120 mA @ 500 Ω
90 mA @ 2 kΩ
18 mA @ 10 kΩ | 120 mA @ 500 Ω
48 mA @ 2 kΩ
11 mA @ 10 kΩ |
| Pulse Width | 300 µs | 300 to 400 µs | 175 µs |
| Frequency | 84 Hz | 1 to 120 Hz | 85 Hz |
| For multiphasic
waveforms only:
-Symmetrical phases?
-Phase Duration
(include units)(state
range, if
applicable)(both
phases, if
asymmetrical) | Yes.
Symmetrical, 300 µs | Yes
Symmetrical, 300 - 400 µs | Yes
Symmetrical, 175 µs |
| Net Charge [µC/Pulse] | 0 [µC] @ 500Ω
Excitation pulse fully
compensated | 0 [µC] @ 500Ω
Excitation pulse fully
compensated | 0.5 [µC] @ 500Ω
Excitation pulse fully
compensated |
| Maximum Phase Charge
[µC] | 21 [µC] @ 500Ω | 48 [µC] @ 500Ω | 21 [µC] @ 500Ω |
| Maximum Current
(RMS) Density
[mA/cm2] | 0.032 mA/cm2 @ 500Ω | 1.49 mA/cm2 @ 500Ω | 0.788 mA/cm2 @ 500Ω |
| Maximum Power
Density [mW/cm2] | 1.25 mW/cm2 @ 500Ω | 27.6 mW/cm2 @ 500Ω | 8.16 mW/cm2 @ 500Ω |
9
| Element | New Device:
FastFit EMS System | Primary Predicate:
Compex Wireless USA | Secondary Predicate:
Katalyst Mark 1 Muscle
Stimulation System Model 2 |
|------------|-----------------------------------|-------------------------------------------|------------------------------------------------------------------------------|
| Burst Mode | N/A | Not publicly available | N/A |
| ON Time | 4 second intervals | Not publicly available | 4 second intervals |
| OFF Time | 4 second intervals | Not publicly available | 4 second intervals |
SUMMARY OF SIMILARITIES / DIFFERENCES:
The FastFit EMS system provides localized electrical muscle stimulation (EMS) pulses to major muscle groups at controllable intensities in the same way as both the predicate devices. All three devices are intended to be used in addition to physical exercise to stimulate healthy muscles in order to improve or facilitate muscle performance. The same fundamental technology platform is employed by all three devices. These devices are all comprised of a set of electrodes powered by a portable battery pack that can deliver an electrical stimulation that is adjustable by the user through a wireless remote user interface. The FastFit EMS system and the Katalyst Mark I both have their electrodes integrated into a wearable body suit, whereas the Compex® Wireless USA allows for each electrode to be independently positioned at the users' discretion.
One notable difference between the FastFit EMS system and the predicate devices is that the FastFit EMS delivers EMS with a much lower maximum current density and power density. This can be accomplished because the FastFit EMS system uses a larger electrode surface area and a lower duty cycle. A lower maximum current and power density for the FastFit represents a lower risk to the user in comparison to the predicate devices.
Another notable difference is in the interface application. The FastFit EMS uses a software application that downloads onto a mobile device (such as a smartphone), whereas the Compex® Wireless uses a software application installed on a proprietary remote device and the Katalyst Mark I uses a software application on a commercially available tablet (Microsoft Surface). Although a few other minor differences exist between the subject and predicate devices (see Basis for Substantial Equivalence Table), these differences do not adversely impact the safety and effectiveness of the subject device.
SUMMARY OF NONCLINICAL TESTING:
Comprehensive design verification and validation testing was performed on the FastFit EMS system. Results from bench and animal testing demonstrated that the function, performance, and safety of the device meet its intended use. Testing performed included a combination of the following:
- System Design Verification Testing ●
- Software Verification and Validation ●
10
- Electrical Safety Testing (IEC 60601-1, IEC 60601-1-11, IEC 60601-1-6, IEC 60601-2-10) ●
- . Electromagnetic Compatibility Testing (IEC 60601-1-2)
- Biocompatibility Testing (ISO 10993-1, ISO 10993-5, and ISO 10993-10) ●
- Usability/Human Factors Testing
Overall, testing confirmed that the FastFit EMS system can be used according to its intended use and in an equivalent manner to the predicate device.
CONCLUSION:
The information and data provided in this 510(k) submission identifies no new safety or effectiveness issues. Based on the above information. FastFit believes that the substantial equivalence of the FastFit EMS system to the Compex Wireless USA and Katalyst Mark 1 has been demonstrated.