Rapid Reboot

K203552 · Rapid Reboot Recovery Products, LLC · IRP · Dec 22, 2020 · Physical Medicine

Device Facts

• Record ID: K203552
• Device Name: Rapid Reboot
• Applicant: Rapid Reboot Recovery Products, LLC
• Product Code: IRP · Physical Medicine
• Decision Date: Dec 22, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5650
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended 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.

Device Story

Rapid Reboot REGEN+, REGEN, and GENESIS are powered inflatable tube massagers for home or clinical use. Devices consist of an air pump, hoses, and four-chambered inflatable sleeves. System operates by sequentially inflating and deflating air chambers to provide distal-to-proximal compression massage. Microprocessor-controlled software manages timing, pressure, and inflation cycles. Users interact via a 6-inch HD LED touchscreen or a Bluetooth-connected smartphone app to adjust intensity (0-200 mmHg), session duration, and massage mode. Powered by external AC supply or integrated rechargeable lithium-ion battery. Output is mechanical compression of limbs; intended to provide temporary relief of minor muscle aches and pains and increase local circulation. Benefits include portability and customizable therapy settings.

Clinical Evidence

No clinical data. Substantial equivalence is supported by benchtop performance testing, including usability studies, pressure/airflow testing, electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), wireless coexistence (ANSI C63.27-2017), and biocompatibility (cytotoxicity, irritation, sensitization).

Technological Characteristics

Powered inflatable tube massager; 4-chambered garment; 12VDC power via IEC 60601-1 supply or integrated Li-ion battery; 6" HD LED touchscreen interface; BLE connectivity; ABS/carbon fiber housing. Software-controlled sequential gradient/peristaltic inflation. Pressure range 0-200 mmHg. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and ANSI C63.27-2017.

Indications for Use

Indicated for healthy individuals seeking temporary relief of minor muscle aches and pains and temporary increase in circulation to treated areas via simulated kneading and stroking of tissues using an inflatable garment.

Regulatory Classification

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.

Predicate Devices

• Rapid Reboot Compression Therapy System (K182668)

Reference Devices

• NormaTec Pulse 2.0 and Pulse Pro 2.0 (K183169)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) | |
|-------------------------------------------------|---------------------------------------|
| <div> <input type="checkbox"/> </div> | <div> <input type="checkbox"/> </div> |

| | 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: [phone] ext. 405

Contact Person: David Johnson, CEO Date Prepared: October 7, 2020

11. 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). -

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.

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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<br>(K182668) | Reference Devices<br>(K183169) | Proposed New<br>Devices | Comment |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model Name<br>510(k) Number | Rapid Reboot<br>Compression Therapy<br>System | NormaTec Pulse 2.0<br>and Pulse Pro 2.0 | Rapid Reboot<br>REGEN+, REGEN,<br>and GENESIS<br>510(k): TBD | N/A |
| Manufacturer | Rapid Reboot<br>Recovery Products,<br>LLC | NormaTec Industries,<br>LP | Rapid Reboot<br>Recovery Products,<br>LLC | N/A |
| Prescriptive | No, OTC | No, OTC | Same (OTC) | N/A |
| Indications for Use | The Rapid Reboot<br>Compression Therapy<br>System is indicated<br>for the temporary<br>relief of minor muscle<br>aches and pains and<br>for the temporary<br>increase in circulation<br>to the treated areas in<br>people who are in<br>good health. It<br>simulates kneading<br>and stroking of tissues<br>by using an inflatable<br>garment. | The NormaTec Pulse<br>2.0 and Pulse Pro 2.0<br>are air pressure<br>massagers intended to<br>temporarily relieve<br>minor muscles aches<br>and/or pains, and to<br>temporarily increase<br>circulation to the<br>treated areas | Same as predicate | N/A |
| Intended Use<br>Environment | Clinics, hospital,<br>athlete training, and<br>home environments | Clinics, hospital,<br>athlete training, and<br>home environments | Same | N/A |
| Power Sources | IEC 60601-1<br>compliant integrated<br>power panel with<br>110V direct wall<br>outlet plug | 15 VDC via an IEC<br>60601-1 compliant<br>power supply (100-<br>240VAC input)<br>Integrated<br>rechargeable battery | 12VDC via an IEC<br>60601-1 compliant<br>power supply (100-<br>240VAC input)<br>Integrated<br>rechargeable battery | N/A |
| Software/Firmware<br>Micro-processor<br>Control | PCB | Microprocessor | Microprocessor | N/A |
| Technology | Compressor and valve<br>system that<br>sequentially inflates<br>cells of Attachment. | Compressor and valve<br>system that<br>sequentially inflates<br>cells of Attachment.<br>Bluetooth<br>communication ability | Same as reference | Proposed<br>devices<br>incorporate an<br>FCC certified<br>BLE module<br>that allow using<br>the Rapid<br>Reboot app as<br>an additional<br>interface |
| Compliance with<br>voluntary<br>standards | ES 60601-1, IEC<br>60601-1-2, IEC<br>60601-1-11 | ES 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11<br>ANSI C63.27-2017 | Same as reference | The proposed<br>devices comply<br>with one<br>additional<br>standard: ANSI<br>C63.27-2017 |
| Device Pressure<br>Range | 0-200 mmHg | 0-110 mmHg | Same as predicate | N/A |
| Intensity Control<br>per Chamber | No | Pulse 2.0: Yes<br>(limited range)<br>Pulse Pro 2.0: Yes | GENESIS: Yes<br>(limited range)<br>REGEN: Yes<br>REGEN+: Yes | N/A |
| Treatment Time | 10, 20, 30 minute<br>time settings | Stays on until the user<br>turns it off or can be<br>set up to turn off in a<br>range of 10 minutes to<br>continuous | GENESIS: 10-60<br>minutes by 10 minute<br>increments<br>REGEN: 1-179<br>minutes by 1 minute<br>increments<br>REGEN+: 1-179<br>minutes by 1 minute<br>increments | N/A |
| Inflation/Deflation<br>Cycle Type | Sequential gradient,<br>peristaltic | Sequential gradient,<br>peristaltic and pulsing | Same as reference | N/A |
| Attachment<br>Contact Surface<br>Material | Interior: 70 denier<br>with thermoplastic<br>polyurethane<br>laminate/extrusion<br>Exterior: 210 denier<br>with thermoplastic<br>polyurethane<br>laminate/extrusion<br>and rip-stop weave | 200 denier nylon with<br>a polyurethane<br>laminate/extrusion | Same as predicate | N/A |
| Number of<br>Inflatable<br>Attachment<br>Chambers | 4 | 5 or less | Same as predicate | N/A |
| Weight | 5.2 lbs | 3.6 lbs (incl. battery) | GENESIS: 4.0 lbs<br>(incl. battery)<br>REGEN: 4.4 lbs (incl.<br>battery)<br>REGEN+: 4.8 lbs<br>(incl. battery) | Differences in<br>weight reflect<br>number of<br>battery packs.<br>GENESIS has<br>one integrated<br>battery pack,<br>REGEN has<br>two, and<br>REGEN+ has<br>three. |
| Dimensions<br>(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<br>models include<br>a new housing<br>design from the<br>predicate to<br>make them<br>smaller and<br>more portable,<br>as well as<br>accommodate<br>modification<br>such as an<br>integrated<br>battery and 6"<br>HD LCD<br>touchscreen |
| Housing Materials<br>and Constructions | Molded ABS<br>enclosure | Molded ABS<br>enclosure | GENESIS: Same<br>REGEN: Same<br>REGEN+: Molded<br>ABS and carbon fiber<br>enclosure | The GENESIS<br>and<br>REGEN control<br>unit housings<br>are comprised<br>of ABS molded<br>parts. The<br>REGEN+<br>control unit<br>housing is<br>comprised of a<br>combination of<br>molded ABS<br>and carbon fiber<br>parts for<br>marketing<br>differentiation. |
| Interface | Segment LED<br>capacitive touch<br>display | Pulse 2.0: 4.3" color<br>LCD screen with<br>smart switches<br>Pulse Pro 2.0: 4.3"<br>color TFT Screen<br>with capacitive sensor | GENESIS, REGEN,<br>& REGEN+: 6" color<br>HD LCD touchscreen<br>(1440p X 720p) | N/A |
| Patient Contact | Non-conductive<br>attachments | Non-conductive<br>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.