(80 days)
No
The description mentions a microprocessor and software controlling timing and pressure based on a sensor, which is standard for automated medical devices and does not indicate AI/ML. There are no mentions of AI, DNN, or ML, nor descriptions of training or test sets typically associated with AI/ML development.
Yes.
The device is indicated for temporary relief of minor muscle aches and pains and temporary increase in circulation, which are therapeutic claims. It also lists medical device safety standards for electrical safety, EMC, and biocompatibility, further indicating its therapeutic intent.
No
The device is indicated for temporary relief of muscle aches and pains and increased circulation, simulating tissue kneading and stroking, rather than identifying or characterizing diseases or conditions.
No
The device description explicitly states it consists of an air pump, air pressure sensor, and sleeves, which are hardware components. The software controls these hardware components.
Based on the provided information, the Rapid Reboot Compression Therapy System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the temporary relief of muscle aches and pains and temporary increase in circulation. This is a physical therapy/rehabilitation type of application, not a diagnostic test performed on samples taken from the body.
- Device Description: The device works by applying external pressure through inflatable garments. It does not analyze biological samples (like blood, urine, tissue, etc.).
- IVD Definition: IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. The Rapid Reboot does not perform this function.
- Performance Studies: The performance studies listed focus on electrical safety, EMC, and biocompatibility, which are relevant for medical devices that interact with the body externally, not for diagnostic accuracy of analyzing samples.
Therefore, the Rapid Reboot Compression Therapy System falls under the category of a physical therapy or rehabilitation device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
IRP
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Leg (consisting of foot, calf, knee, upper leg)
Hip (consisting of upper legs, glutes, hips, lower back)
Arm (consisting of entire arm, shoulder, upper chest and back)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinics, hospital, athlete training, and home environments. Over-The-Counter Use.
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)
Rapid Reboot has been tested and met the requirements of the following standards:
-
- Electrical Safety IEC 60601-1:2014... Medical electrical equipment Part 1: General requirements for basic safety and essential performance
-
- 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;
-
- Biocompatibility EN ISO 10993-5:2009... Biological evaluations of medical devices -- Part 5: Tests for In Vitro cytotoxicity
-
- Biocompatibility EN ISO 10993-10:2010... Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
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.
- Biocompatibility EN ISO 10993-10:2010... Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
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
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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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3
510(k) Summary
| 1. | 510(k) Submitter: | Rapid Reboot Recovery Products, LLC
1396 W 200 S Bldg 2A, Lindon, UT 84042
Phone: 801-899-7511
Email: david@rapidreboot.com | |
|----|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Company Contact: | David Johnson, CEO | |
| 3. | Date of Submission: | September 17, 2018 | |
| 4. | 510(k) Preparer: | John F. Gillespy, MBA
FDA 510k Consulting, LLC
Palm Beach Gardens, FL 33410
Phone: 386-243-4332
Email: john@fda510kconsultants.com | |
| 5. | Device Classification: | Trade name:
Common name:
Device:
Regulation:
Class:
Product Code: | Rapid Reboot Compression Therapy System
Powered Inflatable Tube Massager
Massager, Powered Inflatable Tube
890.5650
2
IRP |
| 6. | Predicate (Primary): | Applicant:
Device:
510(k) Number: | Salton, Inc (Washington, DC)
Relaxor Perfect Touch Air Massaging System
K030437 |
| | Predicate (Secondary): | Applicant:
Device:
510(k) Number: | NormaTec Industries, LP (Newton, PA)
NormaTec Pulse; Norma Tec Pulse Pro
K160608 |
| | Reference: | Applicant:
Device:
510(k) Number: | Xiamen Senyang Co, Ltd (Xinglin Xiamen,
China)
Pt 1002 Pressure Therapy System
K161907 |
-
- 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
-
- 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 | ||||
| Products, LLC | SALTON, INC | NORMATEC INDUSTRIES, LP | XIAMEN SENYANG CO, | ||
| LTD | NA | ||||
| 510(k) | |||||
| Number | K182668 | K030437 | K160608 | K161907 | NA |
| Model Name | Rapid Reboot Compression | ||||
| Therapy System | Relaxor Perfect Touch Air | ||||
| Massaging System | NormaTec Pulse and | ||||
| NormaTec Pulse Pro | Pt 1002 | NA | |||
| Classification | Class II Device, IRP (21 | ||||
| CFR890.5650) | Class II Device, IRP (21 | ||||
| CFR890.5650) | Class II Device, IRP (21 | ||||
| CFR890.5650) | Class II Device, IRP (21 | ||||
| CFR890.5650) | Same | ||||
| Indications for | |||||
| Use (IFU) | The Rapid Reboot | ||||
| Compression Therapy | |||||
| System is intended 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. The Rapid | |||||
| Reboot Compression | |||||
| Therapy System simulates | |||||
| kneading and stroking of | |||||
| tissues by using an | |||||
| inflatable garment. | The Perfect Touch Air | ||||
| Massaging 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. The Perfect | |||||
| Touch simulates kneading and | |||||
| stroking of tissues by using an | |||||
| inflatable garment. | The NormaTec Pulse and Pulse | ||||
| Pro is an air pressure massager | |||||
| intended to temporarily relieve | |||||
| minor muscle aches and/or | |||||
| pains, and to temporarily | |||||
| lincrease circulation to the | |||||
| treated areas. | Indicated for treatment | ||||
| of medical conditions | |||||
| such as primary | |||||
| lymphedema, edema | |||||
| following trauma and | |||||
| sport injuries, post | |||||
| immobilization | |||||
| edema, venous | |||||
| insufficiencies, | |||||
| lymphedema | Same as Relaxor | ||||
| and NormaTec | |||||
| (predicates). | |||||
| OTC or Rx | ОТС | ОТС | ОТС | Rx | Same as |
| predicates | |||||
| Environment | |||||
| of Use: | Clinics, hospital, athlete | ||||
| training, and home | |||||
| environments | Home environment | Clinics, hospital, athlete | |||
| training, and home | |||||
| environments | Clinics, hospital, athlete | ||||
| training and home | |||||
| environments | Essentially the | ||||
| same |
6
| Standards | IEC 60601-1:2014; IEC
60601-1-2:2014; EN ISO
10993-5:2009 & EN ISO
10993-10:2010 | Not available | ES 60601-1; IEC 60601-1-2;
IEC 60601-1-11 | IEC 60601-1:2014; IEC
60601-1-2:2014; EN ISO
10993-5:2009 & EN ISO
10993-10:2010 | Meets consensus
stds for ES, EMC,
Biocompatibility |
|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Mode of
Compression | Sequential/Peristaltic | Sequential/Peristaltic | Sequential/Peristaltic and
Pulsing | Sequential/Peristaltic | Same except for
NormaTec
pulsing mode. |
| Power
Source | 110 V, 60Hz | 120V, 60Hz | 100- 240 VAC input | 110 V, 60Hz | Same |
| Therapy Time | User determines therapy
time. Choose from 10, 20,
or 30 minute session time,
with option to add
additional 10 minutes to
any therapy time. | Has 15 minute sessions. | User determines therapy
time, with range of 10
minutes to a continuous
session. | User determines therapy
time. Choose from 10,
20, or 30 minute session
time, with option to add
additional 10 minutes to
any therapy time. | Same except
Normatec allows
unrestricted time
use. |
| Max Pressure
Min Pressure | 0-200 mmHg | 80 to 250 mmHg | 30-110 mmHg | 0-200 mmHg | Same as Xiamen,
similar to
Relaxor. |
| Number of
Chambers | 4 Chambers | 12 chambers | 5 chambers | 4 Chambers | Same except
Relaxor has more
chambers |
| Compression
Applicator
Garments
Sleeve
Material | Nylon with a Polyurethane
laminate | Nylon with a Polyurethane
laminate | Nylon with a
polyurethane
laminate | Nylon with a
Polyurethane laminate | Same |
| Housing
Materials
And
Constructions | Molded ABS enclosure | Molded ABS enclosure | Molded ABS enclosure | Molded ABS enclosure | Same |
| Patient contact | Non-conductive
attachments | Non-conductive attachments | Non-conductive
attachments | Non-conductive
attachments | Same |
| Power
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
Relaxor has
variable cycle
time and
Normatec is
slightly slower | "Leg" Attachment | Leg (consisting of foot, calf,
knee, upper leg) | Leg (consisting of foot and calf). | Leg (consisting of foot, calf,
knee, upper leg). | Leg (consisting or foot,
calf, knee, upper leg) | Same |
|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|-----------------------------------------------------------------------------------------------------|--------------------------------------------|----------------------------------------------------------------|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Size and photo | 10" x 6.5" x 5"
Image: Rapid Reboot device | 9" x 6" x 6"
Image: Relaxor device | 4" x 5" x 9"
Image: Normatec device | 10" x 6.5" x 5"
Image: Leg compression device | All are tabletop
or handheld
portable | Leg Attachment
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
immaterial | Leg Attachment
Sizes | X-Short: 14" x 41"
Short: 14" x 43"
Medium: 14" x 45"
Long: 14" x 48"
X-Long: 14" x 52" | One size: 10" x 22" | Short: 14" x 43"
Standard: 14" x 48"
Tall: 14" x 60" | Small: 11" x 35"
Large: 11" x 43" | Slight variation.
Rapid Reboot
offers two
additional sizes
to NormaTec, to
better suit the
anatomy of each
user. |
| Modes (Inflation
sequences, all
preprogrammed) | 2 modes: "A" mode inflates
and deflates chambers from
bottom up (distal to
proximal chambers), one at
a time. "B" mode also
inflates chambers from
bottom up, but maintains
pressure in lower chambers
as works its way to top.
Then all chambers release
pressure at same time once
all chambers have
sequentially inflated. | 1 mode: inflates and deflates
chambers from bottom up
(distal to proximal chambers),
one at a time. | 2 different mode settings:
"Sequential" mode is same
as "A" mode for Rapid
Reboot, inflating chambers
from bottom up (distal to
proximal), one at a time.
"Normatec Pulse Massage
Pattern" pulses one zone
while previous two hold,
moving sequentially up
extremity. | 2 modes: "A" mode
inflates and deflates
chambers from bottom
up (distal to proximal
chambers), one at a
time. "B" mode also
inflates chambers from
bottom up, but
maintains pressure in
lower chambers as
works its way to top.
Then all chambers
release pressure at same
time once all chambers
have sequentially
inflated. | reference device.
All devices have
sequential mode
(distal to
proximal
chambers). | "Hip" Attachment | Hip (consisting of upper
legs, glutes, hips, lower
back) | Back (consisting of lower and
mid back) | Hip (consisting of upper
legs, glutes, hips, lower
back) | Waist (consisting of
lower and mid back) | Same as
NormaTec |
| Modes (visual
description) | Mode A: | Only has one mode. Follows
this sequence: | "Sequential:" | Mode A: | Same | Hip Attachment
Photos | Image: Hip Attachment Photos 1 | Image: Hip Attachment Photos 2 | Image: Hip Attachment Photos 3 | Image: Hip Attachment Photos 4 | Same as
NormaTec |
| Image: Mode A | Image: Mode A sequence | Image: Sequential | Image: Mode A | Image: Same | | | | | | | |
| Image: Mode B | Mode B: | | "Pulse Massage Pattern:"
Image: Pulse Massage Pattern
Zone 1 pulses
Zone 2 pulses, Zone 1 holds
Zone 3 pulses, Zone 1 & 2 hold
Zone 4 pulses, Zone 2 & 3 hold
Zone 5 pulses, Zone 3 & 4 hold | Image: Mode B | Same as Xiamen.
Slight variation
with Normatec
which holds up
to 3 chambers at
a time and Rapid
Reboot holding
up to 4. | | | | | | |
8
9
10
| Hip Attachment
Sizes | Regular:
26" x 32"
Large: 26"
35" | One size: 14" x 40" | One size:
28" x 32" | Small: 15" x 47"
Large: 15" x 62" | Slight variation. |
|-------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|---------------------|
| "Arm"
Attachment | Arm (consisting of entire
arm, shoulder, upper chest
and back) | Arm (consisting of forearm,
lower bicep) | Arm (consisting of entire
arm, shoulder, upper chest
and back) | Arm (consisting of entire
arm, shoulder) | Same as
NormaTec |
| Arm Attachment
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
Sizes | Regular: 18" x 38"
Long: 18" x 44" | One size: 8" x "16 | One size: 16" x 38" | Small: 9" x 27"
Large: 9" x 35" | Slight variation. |
| Safety Features | Button on display allows
user to stop or pause
therapy session at any time. | Button on display allows user
to stop or pause therapy
session at any time. | Button on display allows
user to stop or pause
therapy session at any time. | Button on display allows
user to stop or pause
therapy session at any
time. | Same |
| SW/Firmware/
Microprocessor
Control | Microprocessor | Microprocessor | Microprocessor | Microprocessor | Same |
11
| Technology | Compressor and valve system which sequentially
inflates cells of appliance | Compressor and valve system
which sequentially inflates cells
of appliance | Compressor and valve system which sequentially
inflates cells of appliance | Compressor and valve system which
sequentially inflates cells
of appliance | Same |
| ------------ | ------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------- | ------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------- | ------ |
|---|
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12
-
- Performance Testing... Rapid Reboot has been tested and met the requirements of the following standards:
-
- Electrical Safety IEC 60601-1:2014... Medical electrical equipment Part 1: General requirements for basic safety and essential performance
-
- 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;
-
- Biocompatibility EN ISO 10993-5:2009... Biological evaluations of medical devices -- Part 5: Tests for In Vitro cytotoxicity
-
- Biocompatibility EN ISO 10993-10:2010... Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
-
- 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.