(18 days)
No
The description mentions software controlling timing and pressure based on sensors and microprocessors, and a user interface for manual control of settings. There is no mention of the device learning from data, adapting its behavior based on user input or physiological feedback beyond simple sensor readings, or using complex algorithms typically associated with AI/ML for decision-making or pattern recognition. The app functionality is limited to mimicking the device interface and providing informational features and saved settings.
Yes
The device is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas, which are therapeutic claims.
No
The device is described as a powered inflatable tube massager used for temporary relief of minor muscle aches and pains and increased circulation. Its function is to provide therapy, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly details hardware components including an air pump, inflatable garments, hoses, sensors, microprocessors, a user interface touchscreen, and a power supply/battery. While software controls the device, it is integral to the operation of the physical hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Rapid Reboot Compression Therapy Systems are described as powered inflatable tube massagers that simulate kneading and stroking of tissues using an inflatable garment. Their intended use is for temporary relief of minor muscle aches and pains and temporary increase in circulation.
- Lack of Biological Sample Analysis: The device does not analyze any biological samples from the human body. It applies external pressure to the limbs.
- No Diagnostic Purpose: The device is not used to diagnose any disease or condition. Its purpose is therapeutic (temporary relief of symptoms) and for increasing circulation.
Therefore, the Rapid Reboot Compression Therapy Systems fall under the category of physical therapy or massage devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Rapid Reboot REGEN+, REGEN, or GENESIS Compression Therapy Systems are indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The Rapid Reboot REGEN, or GENESIS Compression Therapy Systems simulate kneading and stroking of tissues by using an inflatable garment.
Product codes (comma separated list FDA assigned to the subject device)
IRP
Device Description
The Rapid Reboot GENESIS, REGEN, and REGEN+ model systems are powered inflatable tube massagers (Product Code IRP). They are indicated for the temporary relief of minor muscle aches and pains and for the temporary increase in circulation to the treated areas in people who are in good health. They simulate kneading and stroking of tissues by using an inflatable garment. The air pump is connected to the dedicated sleeves via a series of hoses, and each sleeve has four (4) compression chambers. The compression massage direction is from limb end to body center (distal to proximal). By inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the user. The sleeve works under the action of sensors and microprocessors. Software controls the timing and pressure reflected by the sensor, cycling airflow into and out of the sleeves to compress the body in a controlled and specific manner. Each unit also has a user interface that allows users the ability to control several aspects of the massage: i.e., intensity (pressure), session duration, and mode. The devices are powered by an external IEC 60601-1 compliant power supply and can also be powered by an internal IEC 62133-compliant lithium-ion battery.
The user interface on the GENESIS, REGEN, and REGEN+ models is a 6" HD LED touchscreen with capacitive sensors identical to most smartphones. The user interface provides for: -Starting and stopping the massage treatment; Adjusting the time, intensity (pressure), and type of distal-to-proximal sequence (Mode). - While the main functions, indications for use, and parameters of settings are the same on the three models, there are differences in non-crucial features and resolution of settings that are intended for marketing differentiation and user preferences: e.g., the REGEN and REGEN+ models offer pressure resolution of 5 mmHg from 0 to 200 mmHg for a total of 40 potential pressure settings, while the GENESIS only offers 7 pressure settings. Similarly, the REGEN and REGEN+ allow the user to set the session duration, or time, to the minute between 1 and 179 minutes (2 hrs and 59 minutes), the GENESIS only allows the user to set a session duration of 10, 20, 30, 40, 50, or 60 minutes.
In addition to the user interface on these respective devices, these proposed models have Bluetooth Low Energy (BLE) capability that allows the use of a Rapid Reboot app to control a device. The app mimics the device interface graphics and buttons, allowing the user to use a compatible Android or iOS powered smartphone or tablet to control the devices core functions just as if they were using the interface on the device. The app functionality is limited to mimicking the device interface and does not provide additional settings that alter the therapy provided by the device. When paired with a REGEN or REGEN+, the app does offer additional, non-critical and non-function related for marketing differentiation and user preferences: e.g., informational features in the menu, programs (i.e., saved settings) that can be saved and quickly applied to future sessions, and the ability to access logs showing usage.
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
Clinics, hospital, athlete training, and home environments
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 following performance data were provided in support of the substantial equivalence determination.
Sterilization & Shelf-life Testing: The device is shelf-stable and not sterile, therefore sterilization and shelf-life testing was not necessary to demonstrate the safety or performance of the device.
Biocompatibility Testing: Cytotoxicity, Irritation, and Sensitization testing was conducted to demonstrate the biocompatibility of the patient-contacting materials of the Rapid Reboot devices.
Electrical safety and electromagnetic compatibility (EMC): The subject device passed all electrical safety and EMC tests. Electrical Safety Testing was conducted in accordance with IEC 60601-1 Medical Electrical Equipment - General Requirements for Basic Safety and Essential Performance and ANSI IEEE C63.27-2017 American National Standard for Evaluation of Wireless Coexistence. EMC Testing was conducted in accordance with IEC 60601-1-2 General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests.
Software Verification and Validation Testing: Software Verification and Validation Testing was conducted in accordance with IEC 62304 Medical Device Software - Software Life Cycle Processes.
Mechanical and acoustic Testing: Mechanical Stress Testing was conducted as described above in the performance testing.
Animal Study: Animal performance testing was not required to demonstrate safety and effectiveness of the device.
Clinical Studies: Clinical testing was not required to demonstrate the safety and effectiveness of the Rapid Reboot devices. Instead, substantial equivalence is based upon benchtop performance testing.
Usability Studies: A Usability Study was conducted to ensure that intended users are able to properly use the device as indicated to fulfil its intended use.
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.
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
§ 890.5650 Powered inflatable tube massager.
(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(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.
December 22, 2020
Rapid Reboot Recovery Products, LLC % Prithul Bom Regulatory Technology Services, LLC 1000 Westgate Drive. Suite 510k Saint Paul, Minnesota 55114
Re: K203552
Trade/Device Name: Rapid Reboot Regulation Number: 21 CFR 890.5650 Regulation Name: Powered inflatable tube massager Regulatory Class: Class II Product Code: IRP Dated: December 2, 2020 Received: December 4, 2020
Dear Prithul Bom:
We have reviewed vour 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/cfpmp/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 mediation-emitting products, including information about labeling regulations, please see Device (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,
Heather Dean, PhD Assistant Director. Acute Injury Devices Team 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
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Indications for Use
510(k) Number (if known) K203552
Device Name Rapid Reboot
Indications for Use (Describe)
The Rapid Reboot REGEN+, REGEN, or GENESIS Compression Therapy Systems are indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The Rapid Reboot REGEN, or GENESIS Compression Therapy Systems simulate kneading and stroking of tissues by using an inflatable garment.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| | Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:
l. SUBMITTER Rapid Reboot Recovery Products, LLC 1396 W 200 S, Building 2, Unit A Lindon, Utah 84042 Tel: +1.801.704.5271 ext. 405
Contact Person: David Johnson, CEO Date Prepared: October 7, 2020
- DEVICE
Name of Device: Rapid Reboot REGEN+ Rapid Reboot REGEN Rapid Reboot GENESIS Classification Name: Powered Inflatable Tube Massager Regulation: 21 CFR §890.5650 Regulatory Class: Class II Product Classification Code: IRP
III. PREDICATE AND REFERENCE DEVICE
| Predicate Manufacturer: | Rapid Reboot Recovery Products, LLC |
|---|---|
| Predicate Trade Name: | Rapid Reboot Compression Therapy System |
| Predicate 510(k): | K182668 |
| Reference Manufacturer: | NormaTec Industries, LP |
| Reference Trade Name: | NormaTec Pulse 2.0 and Pulse Pro 2.0 |
| Reference 510(k): | K183169 |
DEVICE DESCRIPTION IV.
The Rapid Reboot GENESIS, REGEN, and REGEN+ model systems are powered inflatable tube massagers (Product Code IRP). They are indicated for the temporary relief of minor muscle aches and pains and for the temporary increase in circulation to the treated areas in people who are in good health. They simulate kneading and stroking of tissues by using an inflatable garment. The air pump is connected to the dedicated sleeves via a series of hoses, and each sleeve has four (4) compression chambers. The compression massage direction is from limb end to body center (distal to proximal). By inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the user. The sleeve works under the action of sensors and microprocessors. Software controls the timing and pressure reflected by the sensor, cycling airflow into and out of the sleeves to compress the body in a controlled and specific manner. Each unit also has a user interface that allows users the ability to control several aspects of the massage: 1.e., intensity (pressure), session duration, and mode. The devices are powered by an external IEC 60601-1 compliant power supply and can also be powered by an internal IEC 62133-compliant lithium-ion battery.
The user interface on the GENESIS, REGEN, and REGEN+ models is a 6" HD LED touchscreen with capacitive sensors identical to most smartphones. The user interface provides for:
4
- -Starting and stopping the massage treatment;
- Adjusting the time, intensity (pressure), and type of distal-to-proximal sequence (Mode). -
While the main functions, indications for use, and parameters of settings are the same on the three models, there are differences in non-crucial features and resolution of settings that are intended for marketing differentiation and user preferences: e.g., the REGEN and REGEN+ models offer pressure resolution of 5 mmHg from 0 to 200 mmHg for a total of 40 potential pressure settings, while the GENESIS only offers 7 pressure settings. Similarly, the REGEN and REGEN+ allow the user to set the session duration, or time, to the minute between 1 and 179 minutes (2 hrs and 59 minutes), the GENESIS only allows the user to set a session duration of 10, 20, 30, 40, 50, or 60 minutes.
In addition to the user interface on these respective devices, these proposed models have Bluetooth Low Energy (BLE) capability that allows the use of a Rapid Reboot app to control a device. The app mimics the device interface graphics and buttons, allowing the user to use a compatible Android or iOS powered smartphone or tablet to control the devices core functions just as if they were using the interface on the device. The app functionality is limited to mimicking the device interface and does not provide additional settings that alter the therapy provided by the device. When paired with a REGEN or REGEN+, the app does offer additional, non-critical and non-function related for marketing differentiation and user preferences: e.g., informational features in the menu, programs (i.e., saved settings) that can be saved and quickly applied to future sessions, and the ability to access logs showing usage.
V. INDICATIONS FOR USE
The Rapid Reboot REGEN+, REGEN, or GENESIS Compression Therapy Systems are indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The Rapid Reboot REGEN, or GENESIS Compression Therapy Systems simulate kneading and stroking of tissues by using an inflatable garment.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVCE
The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence:
- Indications for Use The predicate and subject device have identical indications for use. ● Both are indicated for temporary relief of minor aches and pains and for temporary increase in circulation to treated areas in people who are in good health. They both simulate kneading and stroking of tissues by using an inflatable garment.
- . Materials - The predicate and subject device are made of similar patient-contacting materials. The exact materials are different between the subject device and predicate device but biocompatibility testing including cytotoxicity, sensitization, and irritation testing has been completed to demonstrate that the new material is as safe as the predicate device.
- Design – The predicate and subject device have the same fundamental design of an external automated air pump, wearable garments, and software controls. The subject device introduces a new software user interface that has been validated to perform as well as the predicate device.
- Energy Source - The predicate device uses a direct wall outlet plug to power the system. The subject device is powered by 12VDC via an IEC 60601-1 compliant power supply (100-240VAC input) Integrated rechargeable battery. Electrical Safety and EMC testing was conducted to ensure that the change in energy source is as safe and effective as the predicate.
5
- . Other Design Features – The proposed models include a new housing design from the predicate to make them smaller and more portable as well as accommodate the integrated battery and 6" LCD touchscreen.
- Performance Testing The predicate and subject device involved the following testing: .
- Human Factors Engineering Usability Testing Report o
- Minimum, Interval, and Maximum Air Pressure Test o
- Maximum Electric Current Value Test o
- o Maximum Airflow Valve Test
- o Noise Level Test
- 0
- Button and Display Test O
- o
| | Predicate Device
(K182668) | Reference Devices
(K183169) | Proposed New
Devices | Comment |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model Name
510(k) Number | Rapid Reboot
Compression Therapy
System | NormaTec Pulse 2.0
and Pulse Pro 2.0 | Rapid Reboot
REGEN+, REGEN,
and GENESIS
510(k): TBD | N/A |
| Manufacturer | Rapid Reboot
Recovery Products,
LLC | NormaTec Industries,
LP | Rapid Reboot
Recovery Products,
LLC | N/A |
| Prescriptive | No, OTC | No, OTC | Same (OTC) | N/A |
| Indications for Use | The Rapid Reboot
Compression Therapy
System is indicated
for the temporary
relief of minor muscle
aches and pains and
for the temporary
increase in circulation
to the treated areas in
people who are in
good health. It
simulates kneading
and stroking of tissues
by using an inflatable
garment. | The NormaTec Pulse
2.0 and Pulse Pro 2.0
are air pressure
massagers intended to
temporarily relieve
minor muscles aches
and/or pains, and to
temporarily increase
circulation to the
treated areas | Same as predicate | N/A |
| Intended Use
Environment | Clinics, hospital,
athlete training, and
home environments | Clinics, hospital,
athlete training, and
home environments | Same | N/A |
| Power Sources | IEC 60601-1
compliant integrated
power panel with
110V direct wall
outlet plug | 15 VDC via an IEC
60601-1 compliant
power supply (100-
240VAC input)
Integrated
rechargeable battery | 12VDC via an IEC
60601-1 compliant
power supply (100-
240VAC input)
Integrated
rechargeable battery | N/A |
| Software/Firmware
Micro-processor
Control | PCB | Microprocessor | Microprocessor | N/A |
| Technology | Compressor and valve
system that
sequentially inflates
cells of Attachment. | Compressor and valve
system that
sequentially inflates
cells of Attachment.
Bluetooth
communication ability | Same as reference | Proposed
devices
incorporate an
FCC certified
BLE module
that allow using
the Rapid
Reboot app as
an additional
interface |
| Compliance with
voluntary
standards | ES 60601-1, IEC
60601-1-2, IEC
60601-1-11 | ES 60601-1
IEC 60601-1-2
IEC 60601-1-11
ANSI C63.27-2017 | Same as reference | The proposed
devices comply
with one
additional
standard: ANSI
C63.27-2017 |
| Device Pressure
Range | 0-200 mmHg | 0-110 mmHg | Same as predicate | N/A |
| Intensity Control
per Chamber | No | Pulse 2.0: Yes
(limited range)
Pulse Pro 2.0: Yes | GENESIS: Yes
(limited range)
REGEN: Yes
REGEN+: Yes | N/A |
| Treatment Time | 10, 20, 30 minute
time settings | Stays on until the user
turns it off or can be
set up to turn off in a
range of 10 minutes to
continuous | GENESIS: 10-60
minutes by 10 minute
increments
REGEN: 1-179
minutes by 1 minute
increments
REGEN+: 1-179
minutes by 1 minute
increments | N/A |
| Inflation/Deflation
Cycle Type | Sequential gradient,
peristaltic | Sequential gradient,
peristaltic and pulsing | Same as reference | N/A |
| Attachment
Contact Surface
Material | Interior: 70 denier
with thermoplastic
polyurethane
laminate/extrusion
Exterior: 210 denier
with thermoplastic
polyurethane
laminate/extrusion
and rip-stop weave | 200 denier nylon with
a polyurethane
laminate/extrusion | Same as predicate | N/A |
| Number of
Inflatable
Attachment
Chambers | 4 | 5 or less | Same as predicate | N/A |
| Weight | 5.2 lbs | 3.6 lbs (incl. battery) | GENESIS: 4.0 lbs
(incl. battery)
REGEN: 4.4 lbs (incl.
battery)
REGEN+: 4.8 lbs
(incl. battery) | Differences in
weight reflect
number of
battery packs.
GENESIS has
one integrated
battery pack,
REGEN has
two, and
REGEN+ has
three. |
| Dimensions
(W x H x D) | 6.5" x 5" x 10" | 4.4" x 3.8" x 8.1" | 5" x 4.5" x 9.5" | The proposed
models include
a new housing
design from the
predicate to
make them
smaller and
more portable,
as well as
accommodate
modification
such as an
integrated
battery and 6"
HD LCD
touchscreen |
| Housing Materials
and Constructions | Molded ABS
enclosure | Molded ABS
enclosure | GENESIS: Same
REGEN: Same
REGEN+: Molded
ABS and carbon fiber
enclosure | The GENESIS
and
REGEN control
unit housings
are comprised
of ABS molded
parts. The
REGEN+
control unit
housing is
comprised of a
combination of
molded ABS
and carbon fiber
parts for
marketing
differentiation. |
| Interface | Segment LED
capacitive touch
display | Pulse 2.0: 4.3" color
LCD screen with
smart switches
Pulse Pro 2.0: 4.3"
color TFT Screen
with capacitive sensor | GENESIS, REGEN,
& REGEN+: 6" color
HD LCD touchscreen
(1440p X 720p) | N/A |
| Patient Contact | Non-conductive
attachments | Non-conductive
attachments | Same | N/A |
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VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Sterilization & Shelf-life Testing
The device is shelf-stable and not sterile, therefore sterilization and shelf-life testing was not necessary to demonstrate the safety or performance of the device.
Biocompatibility Testing
Cytotoxicity, Irritation, and Sensitization testing was conducted to demonstrate the biocompatibility of the patient-contacting materials of the Rapid Reboot devices.
Electrical safety and electromagnetic compatibility (EMC)
The subject device passed all electrical safety and EMC tests. Electrical Safety Testing was conducted in accordance with IEC 60601-1 Medical Electrical Equipment - General Requirements for Basic Safety and Essential Performance and ANSI IEEE C63.27-2017 American National Standard for Evaluation of Wireless Coexistence. EMC Testing was conducted in accordance with IEC 60601-1-2 General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests.
Software Verification and Validation Testing
Software Verification and Validation Testing was conducted in accordance with IEC 62304 Medical Device Software - Software Life Cycle Processes.
Mechanical and acoustic Testing
Mechanical Stress Testing was conducted as described above in the performance testing.
Animal Study
Animal performance testing was not required to demonstrate safety and effectiveness of the device.
Clinical Studies
Clinical testing was not required to demonstrate the safety and effectiveness of the Rapid Reboot devices. Instead, substantial equivalence is based upon benchtop performance testing.
Usabilitv Studies
A Usability Study was conducted to ensure that intended users are able to properly use the device as indicated to fulfil its intended use.
VIII. CONCLUSIONS
Rapid Reboot REGEN+, REGEN, and Genesis are substantially equivalent to the legally marketed Rapid Reboot Compression Therapy System (primary predicate) for Indication for Use, and technological and performance characteristics. Based on the Safety and Effectiveness test reports it is at least as safe and effective as the predicate device and technologically comparable. It does not raise any new safety and/or effectiveness concerns. Hence, it is clear that Rapid Reboot is substantially equivalent to that of the predicate device.