Rapid Reboot Compression Therapy System

K182668 · Rapid Reboot Recovery Products, LLC · IRP · Dec 14, 2018 · Physical Medicine

Device Facts

• Record ID: K182668
• Device Name: Rapid Reboot Compression Therapy System
• Applicant: Rapid Reboot Recovery Products, LLC
• Product Code: IRP · Physical Medicine
• Decision Date: Dec 14, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Rapid Reboot Compression Therapy System is 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 Compression Therapy System simulates kneading and stroking of tissues by using an inflatable garment.

Device Story

Rapid Reboot Compression Therapy System is a powered inflatable tube massager for OTC use in clinics, hospitals, athlete training, or home environments. Device comprises an air pump, air pressure sensor, and multi-chambered sleeves (leg, hip, arm). System operates via microprocessor-controlled compressor and valve assembly that sequentially inflates/deflates compression chambers to simulate kneading and stroking. Users select therapy time (10-30 min) and pressure (20-200 mmHg) via display. Two modes: Mode A (sequential inflation/deflation distal to proximal) and Mode B (sequential inflation with pressure maintenance in lower chambers until all are inflated, then simultaneous release). Output is mechanical compression of limbs/body. Device provides temporary muscle pain relief and circulation increase; helps users manage recovery through controlled, adjustable pneumatic massage.

Clinical Evidence

Bench testing only. No clinical data provided. Device performance validated through electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and biocompatibility (ISO 10993-5, ISO 10993-10) testing.

Technological Characteristics

Powered inflatable tube massager; 4-chambered sleeves (nylon/polyurethane laminate); molded ABS enclosure. Microprocessor-controlled compressor/valve system. Pressure range 0-200 mmHg. Power: 110V, 60Hz. Connectivity: Standalone. Standards: IEC 60601-1, IEC 60601-1-2, EN ISO 10993-5, EN ISO 10993-10.

Indications for Use

Indicated for temporary relief of minor muscle aches/pains and temporary increase in circulation in healthy individuals. Simulates tissue kneading/stroking via 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

• Relaxor Perfect Touch Air Massaging System (K030437)
• NormaTec Pulse; Norma Tec Pulse Pro (K160608)

Reference Devices

• Pt 1002 Pressure Therapy System (K161907)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 14, 2018

Rapid Reboot Recovery Products, LLC % John Gillespy FDA Consulting, LLC 1100 Del Lago Cir #104 Palm Beach Gardens, Florida 33410

Re: K182668

Trade/Device Name: Rapid Reboot Compression Therapy System Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: September 17, 2018 Received: September 25, 2018

Dear John Gillespy:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

{1}------------------------------------------------

statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801; medical device reporting (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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Vivek J. Pinto -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K182668

#### Device Name

Rapid Reboot Compression Therapy System

#### Indications for Use (Describe)

The Rapid Reboot Compression Therapy System is 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 Compression Therapy System simulates 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)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510(k) Summary

| 1. | 510(k) Submitter: | Rapid Reboot Recovery Products, LLC<br>1396 W 200 S Bldg 2A, Lindon, UT 84042<br>Phone: [phone]<br>Email: [e-mail] | |
|----|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Company Contact: | David Johnson, CEO | |
| 3. | Date of Submission: | September 17, 2018 | |
| 4. | 510(k) Preparer: | John F. Gillespy, MBA<br>FDA 510k Consulting, LLC<br>Palm Beach Gardens, FL 33410<br>Phone: [phone]<br>Email: [e-mail] | |
| 5. | Device Classification: | Trade name:<br>Common name:<br>Device:<br>Regulation:<br>Class:<br>Product Code: | Rapid Reboot Compression Therapy System<br>Powered Inflatable Tube Massager<br>Massager, Powered Inflatable Tube<br>890.5650<br>2<br>IRP |
| 6. | Predicate (Primary): | Applicant:<br>Device:<br>510(k) Number: | Salton, Inc (Washington, DC)<br>Relaxor Perfect Touch Air Massaging System<br>K030437 |
| | Predicate (Secondary): | Applicant:<br>Device:<br>510(k) Number: | NormaTec Industries, LP (Newton, PA)<br>NormaTec Pulse; Norma Tec Pulse Pro<br>K160608 |
| | Reference: | Applicant:<br>Device:<br>510(k) Number: | Xiamen Senyang Co, Ltd (Xinglin Xiamen,<br>China)<br>Pt 1002 Pressure Therapy System<br>K161907 |

- 7. Indications For Use... The Rapid Reboot Compression Therapy System is 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 Compression Therapy System simulates kneading and stroking of tissues by using an inflatable garment.

{4}------------------------------------------------

- 8. Device Description... Rapid Reboot Compression Therapy System ("Rapid Reboot") consists of an air pump, air pressure sensor, and sleeves working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses; each sleeve has four (4) compression chambers. The compression massage direction is from limb end to body center. By inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The sleeve works under the action of sensor and microprocessor. Software controls the timing and pressure reflected by the sensor, cycling airflow into and out of the sleeves to compress body

| Name | Rapid Reboot Compression Therapy System |
|-----------------|-----------------------------------------|
| Pressure (mmHg) | 0~200 mmHg |
| Mode | Mode A and Mode B, and the initial is A |
| Interval | 50S |
| Time(min) | Time 0-30, selection (10, 20, 30min) |
| Pressure Time | Pressure, 20-200mmHg, Mode A/B, 0-30Min |

### 9. Technical Characteristics

[Remainder of page left intentionally blank]

{5}------------------------------------------------

## 10. Comparison To Predicate

# Table 5 – Comparison With Predicate

| Device | Subject Device | Primary Predicate | Secondary Predicate | Reference Device | Comparison |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| Manufacturer | Rapid Reboot Recovery<br>Products, LLC | SALTON, INC | NORMATEC INDUSTRIES, LP | XIAMEN SENYANG CO,<br>LTD | NA |
| 510(k)<br>Number | K182668 | K030437 | K160608 | K161907 | NA |
| Model Name | Rapid Reboot Compression<br>Therapy System | Relaxor Perfect Touch Air<br>Massaging System | NormaTec Pulse and<br>NormaTec Pulse Pro | Pt 1002 | NA |
| Classification | Class II Device, IRP (21<br>CFR890.5650) | Class II Device, IRP (21<br>CFR890.5650) | Class II Device, IRP (21<br>CFR890.5650) | Class II Device, IRP (21<br>CFR890.5650) | Same |
| Indications for<br>Use (IFU) | The Rapid Reboot<br>Compression Therapy<br>System is intended for the<br>temporary relief of minor<br>muscle aches and pains and<br>for the temporary increase<br>in circulation to the treated<br>areas in people who are in<br>good health. The Rapid<br>Reboot Compression<br>Therapy System simulates<br>kneading and stroking of<br>tissues by using an<br>inflatable garment. | The Perfect Touch Air<br>Massaging System is indicated<br>for the temporary relief of<br>minor muscle aches and pains<br>and for the temporary<br>increase in circulation to the<br>treated areas in people who<br>are in good health. The Perfect<br>Touch simulates kneading and<br>stroking of tissues by using an<br>inflatable garment. | The NormaTec Pulse and Pulse<br>Pro is an air pressure massager<br>intended to temporarily relieve<br>minor muscle aches and/or<br>pains, and to temporarily<br>lincrease circulation to the<br>treated areas. | Indicated for treatment<br>of medical conditions<br>such as primary<br>lymphedema, edema<br>following trauma and<br>sport injuries, post<br>immobilization<br>edema, venous<br>insufficiencies,<br>lymphedema | Same as Relaxor<br>and NormaTec<br>(predicates). |
| OTC or Rx | ОТС | ОТС | ОТС | Rx | Same as<br>predicates |
| Environment<br>of Use: | Clinics, hospital, athlete<br>training, and home<br>environments | Home environment | Clinics, hospital, athlete<br>training, and home<br>environments | Clinics, hospital, athlete<br>training and home<br>environments | Essentially the<br>same |

{6}------------------------------------------------

| Standards | IEC 60601-1:2014; IEC<br>60601-1-2:2014; EN ISO<br>10993-5:2009 & EN ISO<br>10993-10:2010 | Not available | ES 60601-1; IEC 60601-1-2;<br>IEC 60601-1-11 | IEC 60601-1:2014; IEC<br>60601-1-2:2014; EN ISO<br>10993-5:2009 & EN ISO<br>10993-10:2010 | Meets consensus<br>stds for ES, EMC,<br>Biocompatibility |
|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Mode of<br>Compression | Sequential/Peristaltic | Sequential/Peristaltic | Sequential/Peristaltic and<br>Pulsing | Sequential/Peristaltic | Same except for<br>NormaTec<br>pulsing mode. |
| Power<br>Source | 110 V, 60Hz | 120V, 60Hz | 100- 240 VAC input | 110 V, 60Hz | Same |
| Therapy Time | User determines therapy<br>time. Choose from 10, 20,<br>or 30 minute session time,<br>with option to add<br>additional 10 minutes to<br>any therapy time. | Has 15 minute sessions. | User determines therapy<br>time, with range of 10<br>minutes to a continuous<br>session. | User determines therapy<br>time. Choose from 10,<br>20, or 30 minute session<br>time, with option to add<br>additional 10 minutes to<br>any therapy time. | Same except<br>Normatec allows<br>unrestricted time<br>use. |
| Max Pressure<br>Min Pressure | 0-200 mmHg | 80 to 250 mmHg | 30-110 mmHg | 0-200 mmHg | Same as Xiamen,<br>similar to<br>Relaxor. |
| Number of<br>Chambers | 4 Chambers | 12 chambers | 5 chambers | 4 Chambers | Same except<br>Relaxor has more<br>chambers |
| Compression<br>Applicator<br>Garments<br>Sleeve<br>Material | Nylon with a Polyurethane<br>laminate | Nylon with a Polyurethane<br>laminate | Nylon with a<br>polyurethane<br>laminate | Nylon with a<br>Polyurethane laminate | Same |
| Housing<br>Materials<br>And<br>Constructions | Molded ABS enclosure | Molded ABS enclosure | Molded ABS enclosure | Molded ABS enclosure | Same |
| Patient contact | Non-conductive<br>attachments | Non-conductive attachments | Non-conductive<br>attachments | Non-conductive<br>attachments | Same |
| Power<br>Consumption | 30W | 26W | 14W | 30W | Same |

{7}------------------------------------------------

| Cycle time | 1 min 20 sec | Range of 15 sec to 1 min 5 sec | 7 min 10 sec | 1 min 20 sec | Same except<br>Relaxor has<br>variable cycle<br>time and<br>Normatec is<br>slightly slower | "Leg" Attachment | Leg (consisting of foot, calf,<br>knee, upper leg) | Leg (consisting of foot and calf). | Leg (consisting of foot, calf,<br>knee, upper leg). | Leg (consisting or foot,<br>calf, knee, upper leg) | Same |
|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|-----------------------------------------------------------------------------------------------------|--------------------------------------------|----------------------------------------------------------------|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Size and photo | 10" x 6.5" x 5"<br>Image: Rapid Reboot device | 9" x 6" x 6"<br>Image: Relaxor device | 4" x 5" x 9"<br>Image: Normatec device | 10" x 6.5" x 5"<br>Image: Leg compression device | All are tabletop<br>or handheld<br>portable | Leg Attachment<br>Photos | Image: Leg Attachment Photos 1 | Image: Leg Attachment Photos 2 | Image: Leg Attachment Photos 3 | Image: Leg Attachment Photos 4 | Same |
| Weight | 5.8 pounds | 3.2 pounds | 3.6 pounds | 5.8 pounds | Difference is<br>immaterial | Leg Attachment<br>Sizes | X-Short: 14" x 41"<br>Short: 14" x 43"<br>Medium: 14" x 45"<br>Long: 14" x 48"<br>X-Long: 14" x 52" | One size: 10" x 22" | Short: 14" x 43"<br>Standard: 14" x 48"<br>Tall: 14" x 60" | Small: 11" x 35"<br>Large: 11" x 43" | Slight variation.<br>Rapid Reboot<br>offers two<br>additional sizes<br>to NormaTec, to<br>better suit the<br>anatomy of each<br>user. |
| Modes (Inflation<br>sequences, all<br>preprogrammed) | 2 modes: "A" mode inflates<br>and deflates chambers from<br>bottom up (distal to<br>proximal chambers), one at<br>a time. "B" mode also<br>inflates chambers from<br>bottom up, but maintains<br>pressure in lower chambers<br>as works its way to top.<br>Then all chambers release<br>pressure at same time once<br>all chambers have<br>sequentially inflated. | 1 mode: inflates and deflates<br>chambers from bottom up<br>(distal to proximal chambers),<br>one at a time. | 2 different mode settings:<br>"Sequential" mode is same<br>as "A" mode for Rapid<br>Reboot, inflating chambers<br>from bottom up (distal to<br>proximal), one at a time.<br>"Normatec Pulse Massage<br>Pattern" pulses one zone<br>while previous two hold,<br>moving sequentially up<br>extremity. | 2 modes: "A" mode<br>inflates and deflates<br>chambers from bottom<br>up (distal to proximal<br>chambers), one at a<br>time. "B" mode also<br>inflates chambers from<br>bottom up, but<br>maintains pressure in<br>lower chambers as<br>works its way to top.<br>Then all chambers<br>release pressure at same<br>time once all chambers<br>have sequentially<br>inflated. | reference device.<br>All devices have<br>sequential mode<br>(distal to<br>proximal<br>chambers). | "Hip" Attachment | Hip (consisting of upper<br>legs, glutes, hips, lower<br>back) | Back (consisting of lower and<br>mid back) | Hip (consisting of upper<br>legs, glutes, hips, lower<br>back) | Waist (consisting of<br>lower and mid back) | Same as<br>NormaTec |
| Modes (visual<br>description) | Mode A: | Only has one mode. Follows<br>this sequence: | "Sequential:" | Mode A: | Same | Hip Attachment<br>Photos | Image: Hip Attachment Photos 1 | Image: Hip Attachment Photos 2 | Image: Hip Attachment Photos 3 | Image: Hip Attachment Photos 4 | Same as<br>NormaTec |
| Image: Mode A | Image: Mode A sequence | Image: Sequential | Image: Mode A | Image: Same | | | | | | | |
| Image: Mode B | Mode B: | | "Pulse Massage Pattern:"<br>Image: Pulse Massage Pattern<br>Zone 1 pulses<br>Zone 2 pulses, Zone 1 holds<br>Zone 3 pulses, Zone 1 & 2 hold<br>Zone 4 pulses, Zone 2 & 3 hold<br>Zone 5 pulses, Zone 3 & 4 hold | Image: Mode B | Same as Xiamen.<br>Slight variation<br>with Normatec<br>which holds up<br>to 3 chambers at<br>a time and Rapid<br>Reboot holding<br>up to 4. | | | | | | |

{8}------------------------------------------------

{9}------------------------------------------------

{10}------------------------------------------------

| Hip Attachment<br>Sizes | Regular:<br>26" x 32"<br>Large: 26"<br>35" | One size: 14" x 40" | One size:<br>28" x 32" | Small: 15" x 47"<br>Large: 15" x 62" | Slight variation. |
|-------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|---------------------|
| "Arm"<br>Attachment | Arm (consisting of entire<br>arm, shoulder, upper chest<br>and back) | Arm (consisting of forearm,<br>lower bicep) | Arm (consisting of entire<br>arm, shoulder, upper chest<br>and back) | Arm (consisting of entire<br>arm, shoulder) | Same as<br>NormaTec |
| Arm Attachment<br>Photos | Image: Two Rapid Reboot arm attachments | Image: Person wearing Rapid Reboot arm attachment | Image: NormaTec arm attachment | Image: Blue arm attachment | Same |
| Arm Attachment<br>Sizes | Regular: 18" x 38"<br>Long: 18" x 44" | One size: 8" x "16 | One size: 16" x 38" | Small: 9" x 27"<br>Large: 9" x 35" | Slight variation. |
| Safety Features | Button on display allows<br>user to stop or pause<br>therapy session at any time. | Button on display allows user<br>to stop or pause therapy<br>session at any time. | Button on display allows<br>user to stop or pause<br>therapy session at any time. | Button on display allows<br>user to stop or pause<br>therapy session at any<br>time. | Same |
| SW/Firmware/<br>Microprocessor<br>Control | Microprocessor | Microprocessor | Microprocessor | Microprocessor | Same |

{11}------------------------------------------------

| Technology | Compressor and valve system which sequentially<br>inflates cells of appliance | Compressor and valve system<br>which sequentially inflates cells<br>of appliance | Compressor and valve system which sequentially<br>inflates cells of appliance | Compressor and valve system which<br>sequentially inflates cells<br>of appliance | Same |
|------------|-------------------------------------------------------------------------------|----------------------------------------------------------------------------------|-------------------------------------------------------------------------------|----------------------------------------------------------------------------------|------|
|------------|-------------------------------------------------------------------------------|----------------------------------------------------------------------------------|-------------------------------------------------------------------------------|----------------------------------------------------------------------------------|------|

[Rest of page left intentionally blank]

{12}------------------------------------------------

- 11. Performance Testing... Rapid Reboot has been tested and met the requirements of the following standards:
- 1. Electrical Safety IEC 60601-1:2014... Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- 2. EMC IEC 60601-1-2:2014... Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests;
- 3. Biocompatibility EN ISO 10993-5:2009... Biological evaluations of medical devices -- Part 5: Tests for In Vitro cytotoxicity
- 4. Biocompatibility EN ISO 10993-10:2010... Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- 12. Substantial Equivalence... Rapid Reboot Compression Therapy System is substantially equivalent to the legally marketed Relaxor Perfect Touch Air Massaging System (primary predicate) and Normatec Pulse and Pulse Pro (secondary predicate) for Indication for Use, and it is substantially equivalent in technological and performance characteristics to Pt 1002 Pressure Therapy System (reference device). Based on the Safety and Effectiveness test reports it is at least as safe and effective as the predicate devices and technologically comparable to the reference device, and doesn't raise any new safety and/or effectiveness concerns. Hence, it is clear that Rapid Reboot is substantially equivalent to that of the predicate devices and reference device.