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.

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.

AI/ML Overview

The provided document is a 510(k) Pre-market Notification for the Rapid Reboot REGEN+, REGEN, and GENESIS Compression Therapy Systems. This document is a regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device, rather than a study designed to establish acceptance criteria or device performance with a specific study design for diagnostic accuracy.

Therefore, many of the requested elements (e.g., acceptance criteria table with reported performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, type of ground truth) typically found in studies for diagnostic devices are not applicable to this submission.

However, I can extract information regarding overall performance testing and conclusions used to support the substantial equivalence claim.

Here's a summary based on the provided text, addressing the applicable points:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria for diagnostic performance or specific numerical performance metrics in the way one would for a diagnostic AI. Instead, it demonstrates compliance with recognized standards and successful completion of various types of engineering and usability testing to show the new devices are as safe and effective as the predicate device (K182668). The "performance" here refers to engineering performance rather than diagnostic accuracy.

Test Type	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility Testing	Materials are biocompatible (non-cytotoxic, non-irritating, non-sensitizing).	Passed Cytotoxicity, Irritation, and Sensitization testing.
Electrical Safety (IEC 60601-1)	Compliant with electrical safety standards.	Passed all electrical safety tests.
Electromagnetic Compatibility (IEC 60601-1-2)	Compliant with EMC standards.	Passed all EMC tests.
Wireless Coexistence (ANSI IEEE C63.27-2017)	Compliant with wireless coexistence standards.	Passed all relevant tests.
Software Verification & Validation (IEC 62304)	Software is verified and validated.	Conducted in accordance with IEC 62304.
Mechanical Stress Testing	Device withstands mechanical stress (details not specified).	Conducted (details not specified).
Human Factors Engineering Usability Testing	Intended users can properly use the device (safe and effective).	Usability Study conducted to ensure proper use.
Minimum, Interval, Maximum Air Pressure Test	Air pressure functions within specified ranges.	Test conducted (results not explicitly stated, but implied compliance).
Maximum Electric Current Value Test	Electric current values are within safe limits.	Test conducted (results not explicitly stated, but implied compliance).
Maximum Airflow Valve Test	Airflow valve functions as intended.	Test conducted (results not explicitly stated, but implied compliance).
Noise Level Test	Noise levels are within acceptable limits.	Test conducted (results not explicitly stated, but implied compliance).
Button and Display Test	Buttons and display function as intended.	Test conducted (results not explicitly stated, but implied compliance).

2. Sample size used for the test set and the data provenance

The document does not describe a "test set" in the context of diagnostic data. The "testing" refers to engineering and usability evaluations.
For usability testing, a "Usability Study" was conducted, but the sample size of users is not specified.
The data provenance (country of origin, retrospective/prospective) for any specific performance study is not provided, as the studies are primarily engineering validation rather than clinical data collection.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a physical therapy/recovery device, not a diagnostic AI. There is no concept of "ground truth" established by medical experts for a test set in this context. The "truth" lies in compliance with engineering standards and usability.

4. Adjudication method for the test set

Not applicable. There is no diagnostic test set requiring expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is not an AI diagnostic tool and does not involve human readers interpreting images or data with or without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical therapy system. While it has software, its "performance" is based on its functional operation, safety, and effectiveness in delivering compression therapy, not on an algorithm making standalone diagnostic interpretations.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. See point 3. The "truth" for this device's performance is compliance with electrical, mechanical, biocompatibility, software, and usability standards and functional specifications.

8. The sample size for the training set

Not applicable. This device does not use machine learning in a way that requires a "training set" for diagnostic algorithm development. The software capabilities are for controlling the device's functions, not for learning from data to make predictions or classifications.

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary

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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

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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)

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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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:

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-Starting and stopping the massage treatment;
Adjusting the time, intensity (pressure), and type of distal-to-proximal sequence (Mode). -

V. INDICATIONS FOR USE

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.

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. 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 NewDevices	Comment
Model Name510(k) Number	Rapid RebootCompression TherapySystem	NormaTec Pulse 2.0and Pulse Pro 2.0	Rapid RebootREGEN+, REGEN,and GENESIS510(k): TBD	N/A
Manufacturer	Rapid RebootRecovery Products,LLC	NormaTec Industries,LP	Rapid RebootRecovery Products,LLC	N/A
Prescriptive	No, OTC	No, OTC	Same (OTC)	N/A
Indications for Use	The Rapid RebootCompression TherapySystem is indicatedfor the temporaryrelief of minor muscleaches and pains andfor the temporaryincrease in circulationto the treated areas inpeople who are ingood health. Itsimulates kneadingand stroking of tissuesby using an inflatablegarment.	The NormaTec Pulse2.0 and Pulse Pro 2.0are air pressuremassagers intended totemporarily relieveminor muscles achesand/or pains, and totemporarily increasecirculation to thetreated areas	Same as predicate	N/A
Intended UseEnvironment	Clinics, hospital,athlete training, andhome environments	Clinics, hospital,athlete training, andhome environments	Same	N/A
Power Sources	IEC 60601-1compliant integratedpower panel with110V direct walloutlet plug	15 VDC via an IEC60601-1 compliantpower supply (100-240VAC input)Integratedrechargeable battery	12VDC via an IEC60601-1 compliantpower supply (100-240VAC input)Integratedrechargeable battery	N/A
Software/FirmwareMicro-processorControl	PCB	Microprocessor	Microprocessor	N/A
Technology	Compressor and valvesystem thatsequentially inflatescells of Attachment.	Compressor and valvesystem thatsequentially inflatescells of Attachment.Bluetoothcommunication ability	Same as reference	Proposeddevicesincorporate anFCC certifiedBLE modulethat allow usingthe RapidReboot app asan additionalinterface
Compliance withvoluntarystandards	ES 60601-1, IEC60601-1-2, IEC60601-1-11	ES 60601-1IEC 60601-1-2IEC 60601-1-11ANSI C63.27-2017	Same as reference	The proposeddevices complywith oneadditionalstandard: ANSIC63.27-2017
Device PressureRange	0-200 mmHg	0-110 mmHg	Same as predicate	N/A
Intensity Controlper Chamber	No	Pulse 2.0: Yes(limited range)Pulse Pro 2.0: Yes	GENESIS: Yes(limited range)REGEN: YesREGEN+: Yes	N/A
Treatment Time	10, 20, 30 minutetime settings	Stays on until the userturns it off or can beset up to turn off in arange of 10 minutes tocontinuous	GENESIS: 10-60minutes by 10 minuteincrementsREGEN: 1-179minutes by 1 minuteincrementsREGEN+: 1-179minutes by 1 minuteincrements	N/A
Inflation/DeflationCycle Type	Sequential gradient,peristaltic	Sequential gradient,peristaltic and pulsing	Same as reference	N/A
AttachmentContact SurfaceMaterial	Interior: 70 denierwith thermoplasticpolyurethanelaminate/extrusionExterior: 210 denierwith thermoplasticpolyurethanelaminate/extrusionand rip-stop weave	200 denier nylon witha polyurethanelaminate/extrusion	Same as predicate	N/A
Number ofInflatableAttachmentChambers	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 inweight reflectnumber ofbattery packs.GENESIS hasone integratedbattery pack,REGEN hastwo, andREGEN+ hasthree.
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 proposedmodels includea new housingdesign from thepredicate tomake themsmaller andmore portable,as well asaccommodatemodificationsuch as anintegratedbattery and 6"HD LCDtouchscreen
Housing Materialsand Constructions	Molded ABSenclosure	Molded ABSenclosure	GENESIS: SameREGEN: SameREGEN+: MoldedABS and carbon fiberenclosure	The GENESISandREGEN controlunit housingsare comprisedof ABS moldedparts. TheREGEN+control unithousing iscomprised of acombination ofmolded ABSand carbon fiberparts formarketingdifferentiation.
Interface	Segment LEDcapacitive touchdisplay	Pulse 2.0: 4.3" colorLCD screen withsmart switchesPulse Pro 2.0: 4.3"color TFT Screenwith capacitive sensor	GENESIS, REGEN,& REGEN+: 6" colorHD LCD touchscreen(1440p X 720p)	N/A
Patient Contact	Non-conductiveattachments	Non-conductiveattachments	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.

Regulation Number and Section

§ 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).