(116 days)
No
The description focuses on hardware components, firmware for pressure control, and user-selected settings. There is no mention of adaptive algorithms, learning from data, or features typically associated with AI/ML.
Yes.
The device is explicitly indicated for "the temporary relief of minor muscle aches and pains, and for a temporary increase in blood circulation," and also states it provides "therapeutic warming" and "therapeutic vibrations," all of which are considered therapeutic functions.
No
The device is an air compression therapy device intended for temporary relief of muscle aches and pains and increased blood circulation, not for diagnosing medical conditions.
No
The device description explicitly details hardware components such as consoles, air pumps, valves, circuit boards, batteries, charging ports, inflatable garments, LED strips, and vibrating motors. While it mentions embedded firmware and software verification and validation, the device is fundamentally a hardware system with integrated software, not a software-only medical device.
Based on the provided text, the JetBoots PRO Plus is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The JetBoots PRO Plus does not interact with or analyze any biological specimens.
- The intended use and device description clearly state that the JetBoots PRO Plus is an air compression therapy device applied externally to the legs. Its function is to provide physical pressure, temporary pain relief, and increased blood circulation.
- The performance studies listed focus on electrical safety, mechanical performance, software validation, and usability. These are typical tests for a physical medical device, not an IVD.
Therefore, the JetBoots PRO Plus falls under the category of a physical therapy or rehabilitation device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
JetBoots PRO Plus is an air compression therapy device intended to provide graduated pressure to the legs. JetBoots PRO Plus is indicated for the temporary relief of minor muscle aches and pains, and for a temporary increase in blood circulation to the treated area in good health. JetBoots PRO Plus simulates kneading and stroking of tissues by using an inflatable garment.
Product codes (comma separated list FDA assigned to the subject device)
IRP, ILY, IRO
Device Description
JetBoots PRO Plus is an air compression therapy device intended to provide graduated pressure to the legs. JetBoots PRO Plus is indicated for the temporary relief of minor muscle aches and pains, and for a temporary increase in blood circulation to the treated area in people who are in good health. JetBoots PRO Plus simulates kneading and stroking of tissues by using an inflatable garment.
JetBoots PRO Plus is two leg shaped garments, one that acts a Lead and the other a Support boot. Each boot is comprised of a console (pressure control unit), a control panel or support power button, and a compression garment in the shape of a boot. The console contains an air pump (compressor) to generate the air pressure, four valves to control the outlet air, a circuit board with embedded firmware to control the pressure, an internal rechargeable battery, and a charging port. The console is fixed to the bottom of the foot on each compression garment, which allows for easy wearing on and off.
Each compression boot has four internal overlapping chambers that can be inflated independently of each other. The device can provide different compression levels in the range from 20mmHg to 100mmHg depending on the user's selection. Hold time is set within the range of 0-10 seconds depending on the preset selected and release time is set by default to 15 seconds.
The lead and support JetBoots PRO Plus boots are each powered by an internal rechargeable battery or by an external DC Power Adapter, plugged into a wall electrical outler. The batteries are located inside each console and can be charged while the device operates. A 72W medical grade DC power adapter, which is supplied with the device, is powered from the wall electrical outlet (100-240 VAC, 50-60 Hz) and supplies 15.0V, 4.8A. The 72W DC power adapter is able to support both boots to work, charge, and work and charge at the same time if using the splitter cable provided.
The JetBoots PRO Plus are also capable of providing therapeutic warming via the included Light Emitting Diode (LED) Strips. The LEDs emit an infrared light frequency at 850nm and are provided as an optional treatment modality. They can be utilized for a maximum of 45 minutes, either as a standalone therapy or in tandem with the JetBoots PRO Plus' primary device function, pneumatic compression. Therapeutic warming via infrared LEDs is considered to be an "Other Device Function."
The JetBoots PRO Plus also capable of providing therapeutic vibrations via included vibrating pill motors. These are included for an improved user experience and are considered to be an "Other Device Function" that has no impact on the JetBoots PRO Plus' primary device function.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
legs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance data were provided in support of the substantial equivalence determination, Electrical safety and electromagnetic compatibility (EMC) JetBoots PRO Plus passed all electrical safety and EMC tests, Electrical Safety Testing was conducted in accordance with:
- IEC 60601-1:2005, AMD1:2012 + AMD2:2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-6:2010 + A1:2013 + A2:2020, Medical devices – Application of usability engineering to medical devices
- . IEC 60601-1-11:2015, Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- . IEC 60601-2-83:2019, Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
- o IEC 62133-2:2017 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications Part 2: Lithium systems
- the Advancement of Medical Instrumentation for the evaluation of Wireless Coexistence
EMC Testing was conducted in accordance with:
- IEC / EN 60601-1-2:2014-02, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic Disturbances - Requirements and Tests
- o ANSI C63.18-2014
Sterilization & Shelf-life Testing: JetBoots PRO Plus is not sold sterile or ever intended to be sterilized. Therefore, sterilization testing was not necessary to demonstrate the safety or performance of the device. The subject device has a shelf-life of 1000 hours.
Biocompatibility Testing:
Cytotoxicity, Irritation and Sensitization testing was conducted to demonstrate the biocompatibility of patient-contacting materials of JetBoots PRO Plus in accordance with:
- ISO 10993-5:2009, biological evaluation of medical devices part 5: tests for in vitro ● cytotoxicity
- ISO 10993-10:2021, biological evaluation of medical devices part 10: tests for skin sensitization
- ISO 10993-23:2021, biological evaluation of medical devices - part 23: tests for skin irritation
Software Verification and Validation Testing
Software Verification and Validation Testing was conducted in accordance with IEC 62304:2006 Medical Device Software - Software Life Cycle Processes.
Animal Study
Animal testing was not required to demonstrate safety and effectiveness of JetBoots PRO Plus
Clinical Studies
Clinical testing was not required to demonstrate the safety and effectiveness of the JetBoots PRO Plus.
Non-Clinical Testing
Device Temperature Range Testing was conducted in accordance with "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Heating and Cooling Devices."
The following performance bench testing was conducted:
- Performance test before reliability
- Reliability Bench Test Report
- Performance test after reliability
- Max Pressure Testing for Accuracy During Treatment
- Mechanical Safety Valve Testing
- Air Bladder Testing
Usability Engineering
Usability Study Report, Therabody study TG-RA-Jetboots PRO Plus
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 890.5650 Powered inflatable tube massager.
(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 30, 2024
Therabody, Inc. % Gina Walljasper Principal Consultant GPW Enterprises, LLC 47 Gatehouse Rd Bedminster, New Jersey 07921
Re: K241256
Trade/Device Name: JetBoots PRO Plus Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP, ILY, IRO Dated: August 7, 2024 Received: August 7, 2024
Dear Gina Walljasper:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Advice (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,
Tushar Bansal -S
for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and
2
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
| Submission Number (if known) |
|---|
| ------------------------------ |
Device Name
JetBoots PRO Plus
Indications for Use (Describe)
JetBoots PRO Plus is an air compression therapy device intended to provide graduated pressure to the legs. JetBoots PRO Plus is indicated for the temporary relief of minor muscle aches and pains, and for a temporary increase in blood circulation to the treated area in good health. JetBoots PRO Plus 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 PRAStaff(@fda.hhs.gov
"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."
4
510(k) Summary (as required by 807.92)
(1) SUBMITTER AND OWNER/OPERATOR:
THERABODY, Inc 1640 S Sepulveda Blvd., Suite 300 Los Angeles, CA 90025 Registration Number: 3012386142 FEI Number: 3012386142 Contact Person: CI Frederick III, Director, Quality & Regulatory Compliance Telephone: (484) 888-1290 Email: cj.frederick@therabodycorp.com Date prepared: May 9, 2024
Application Correspondent:
Contact Person: Gina Walljasper Company: GPW Enterprises, LLC Address: 47 Gatehouse Rd., Bedminster, NJ 07921 Tel: (908) 507-6503 Email: gina.gpwconsulting@gmail.com
(2) DEVICE NAME:
Trade Name: JetBoots PRO Plus Common Name: Powered inflatable tube massager Classification Name: Powered inflatable tube massager Device Classification: Class II Review Panel: Neuromodulation and Physical Medicine Devices (DHT5B) Regulation Number: 21 CFR 890.5650 Product Code: IRP, ILY, IRO
- (3) PREDICATE & REFERENCE DEVICE(S): Substantial equivalence is based on following legally marketed devices.
| Sponsor | Therabody, Inc. (formerly Theragun, Inc.) |
|---|---|
| Device Name and Model | RecoveryAir PRO |
| 510(k) Number | K211745 |
| Product Code | IRP |
| Regulation Number | 21 CFR 890.5650 |
| Regulation Class | II |
Primary Predicate Device
5
Primary Reference Device
| Sponsor | LTBIO Co., Ltd. |
|---|---|
| Device Name and Model | OLIZ LTB-1000A |
| 510(k) Number | K221189 |
| Product Code | ILY |
| Regulation Number | 21 CFR 890.5500 |
| Regulation Class | II |
Secondary Reference Device
| Sponsor | Pain Relief Technologies |
|---|---|
| Device Name and Model | ElectroPulse – Pain Relief |
| 510(k) Number | K062532 |
| Product Code | NUH, ILY, IRO |
| Regulation Number | 21 CFR 882.5890 |
| Regulation Class | II |
(4) DESCRIPTION OF THE DEVICE:
JetBoots PRO Plus is an air compression therapy device intended to provide graduated pressure to the legs. JetBoots PRO Plus is indicated for the temporary relief of minor muscle aches and pains, and for a temporary increase in blood circulation to the treated area in people who are in good health. JetBoots PRO Plus simulates kneading and stroking of tissues by using an inflatable garment.
JetBoots PRO Plus is two leg shaped garments, one that acts a Lead and the other a Support boot. Each boot is comprised of a console (pressure control unit), a control panel or support power button, and a compression garment in the shape of a boot. The console contains an air pump (compressor) to generate the air pressure, four valves to control the outlet air, a circuit board with embedded firmware to control the pressure, an internal rechargeable battery, and a charging port. The console is fixed to the bottom of the foot on each compression garment, which allows for easy wearing on and off.
Each compression boot has four internal overlapping chambers that can be inflated independently of each other. The device can provide different compression levels in the range from 20mmHg to 100mmHg depending on the user's selection. Hold time is set within the range of 0-10 seconds depending on the preset selected and release time is set by default to 15 seconds.
6
The lead and support JetBoots PRO Plus boots are each powered by an internal rechargeable battery or by an external DC Power Adapter, plugged into a wall electrical outler. The batteries are located inside each console and can be charged while the device operates. A 72W medical grade DC power adapter, which is supplied with the device, is powered from the wall electrical outlet (100-240 VAC, 50-60 Hz) and supplies 15.0V, 4.8A. The 72W DC power adapter is able to support both boots to work, charge, and work and charge at the same time if using the splitter cable provided.
The JetBoots PRO Plus are also capable of providing therapeutic warming via the included Light Emitting Diode (LED) Strips. The LEDs emit an infrared light frequency at 850nm and are provided as an optional treatment modality. They can be utilized for a maximum of 45 minutes, either as a standalone therapy or in tandem with the JetBoots PRO Plus' primary device function, pneumatic compression. Therapeutic warming via infrared LEDs is considered to be an "Other Device Function."
The JetBoots PRO Plus also capable of providing therapeutic vibrations via included vibrating pill motors. These are included for an improved user experience and are considered to be an "Other Device Function" that has no impact on the JetBoots PRO Plus' primary device function.
(5) INDICATIONS FOR USE:
JetBoots PRO Plus is an air compression therapy device intended to provide graduated pressure to the legs. JetBoots PRO Plus is indicated for the temporary relief of minor muscle aches and pains, and for a temporary increase in blood circulation to the treated area in people who are in good health. JetBoots PRO Plus simulates kneading and stroking of tissues by using an inflatable garment.
(6) COMPARISON WITH PREDICATE & REFERENCE DEVICES:
The following table is a comparison of Therabody's JetBoots PRO Plus, Predicate and Reference devices.
Therabody's JetBoots PRO Plus is substantially equivalent in terms of the technological characteristics, features, specifications, materials, primary mode of operation and indications for use, to the RecoveryAir PRO, K211745. Comparisons to the Primary Reference Device quoted below, OLIZ LTB-1000A, K221189, as well as the Secondary Reference Device, ElectroPulse – Pain Relief, K062532, demonstrate that the additional modalities of Infrared LED Heat and Therapeutic Vibration do not raise additional concerns of safety and effectiveness. Any differences between the Subject Device, PrimaryPredicate Device, and Reference Devices do not raise new issues of safety or effectiveness.
7
Comparison in Detail(s):
Table 1 General Comparison
| Item | Proposed Device
K241256 | Primary Predicate
Device K211745 | Primary Reference
Device K221189 | Secondary Reference
Device K062532 | Remark |
|----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Manufacturer | Therabody, Inc. | Therabody, Inc.
(Formerly
Theragun, Inc.) | LTBIO Co., Ltd. | Pain Relief
Technologies | |
| Product Name | JetBoots PRO Plus | RecoveryAir PRO | OLIZ LTB-1000A | ElectroPulse - Pain
Relief | |
| Classification
Name | Powered inflatable
tube massager | Powered inflatable
tube massager | Infrared Lamp | Transcutaneous
Electrical Stimulator
for Pain Relief | |
| Product Code | IRP, ILY, IRO | IRP | ILY | NUH, ILY, IRO | Similar |
| Regulation No. | 21CFR 890.5650 | 21CFR 890.5650 | 21CFR 890.5500 | 21CFR 882.5890 | Similar |
| Class | 2 | 2 | 2 (Exempt, Underwent
510k) | 2 | SAME |
| Indication for
Use | JetBoots PRO Plus is
an air compression
therapy device
intended to provide
graduated pressure to
the legs.
JetBoots PRO Plus is
indicated for the
temporary relief of
minor muscle aches
and pains, and for a
temporary increase in
blood circulation to
the legs in people
who are in good
health.
JetBoots PRO Plus
simulates kneading
and stroking of
tissues by using an
inflatable garment. | The RecoveryAir
PRO is an air
compression therapy
device intended to
provide graduated
pressure to
compression
garments.
The RecoveryAir
PRO is indicated for
the temporary relief
of minor muscle
aches and pains, and
for a temporary
increase in blood
circulation to the
treated areas in
people who are in
good health.
The RecoveryAir
PRO simulates
kneading and
stroking of tissues
by using an
inflatable garment. | The OLIZ LTB-
1000A is intended to
deliver heat in the IR
spectrum to provide
topical heating for the
purpose of elevating
tissue temperature; for
the temporary relief of
minor muscle and joint
pain, arthritis and
muscle spasm;
relieving stiffness;
promoting the
relaxation of muscle
tissue; and to
temporarily increase
local blood circulation. | TENS: Used for the
temporary relief of
pain associated with
sore and itching
muscles in the lower
back due to strain
from exercise, or
normal household and
work activities.
Vibration: Relaxing
Muscles and relieving
minor aches and
pains.
Heat Lamp: Emits
energy at neat infrared
frequencies to provide
topical heating and to
provide temporary
relief of minor muscle
and joint pain,
arthritis and muscle
spasm; relieving
stiffness, promoting
relaxing of muscle
tissue, and to
temporarily increase
local blood
circulation. | SAME |
| Prescription/OTC | OTC | OTC | OTC | OTC | SAME |
| Item | Proposed Device | Primary Predicate
Device
K211745 | Primary Reference
Device K221189 | Secondary
Reference Device
K062532 | Remark |
| Power Source | Power Adapter:
AC Input: 100 –
240V AC, 50/60Hz,
DC Output: 15.0V,
4.8A, 72W
Or
Internal Battery | Power Adapter:
AC Input: 100 –
240V AC, 50/60
Hz, 12V or internal
battery | Li-ion batteries
(3.7v_1800mA x2) | Not provided. | Similar |
| Dimensions
(LWH) | Console &
Compression boot
(Lead or Support,
deflated and fully
extended):
• S-size:
36.8in (L) *
5.3in (W) *
14.8 (H)
• M-size:
42.9in (L) *
5.3in (W) *
16.1 (H)
• L-size:
46.5in (L) *
5.3in (W) *
16.1 (H) | 8.6in (L) 6.7in (W)
5.1in (H) | Not provided. | Not provided. | Similar |
| Weight | S-size: 6.0lb (per
boot)
M-size: 6.4lb (per
boot)
L-size: 6.7lb (per
boot) | 4.202 pounds | Not provided. | Not provided. | Similar |
| Housing
Materials | Molded PC+ABS
Enclosure | Molded ABS
Enclosure | Not provided. | Not provided. | Similar |
| Sleeves | Compression boots
sleeves attached to
consoles. Sleeves
(extended) only:
S: 80cm (L) 37.5
cm (H)
M: 95cm (L) 41.0
cm (H)
L: 1050cm (L)* 41.0
cm (H) | RecoveryAir
Compression Boots
95*28.7cm | Not provided. | Not provided. | Similar |
| Number of
Chambers | 4 | 4 | Not provided. | Not provided. | SAME |
| Item | Proposed Device | Primary Predicate
Device
K211745 | Primary Reference
Device K221189 | Secondary
Reference Device
K062532 | Remark |
| Modes | Sequential, ISO, or
Static Flow Cycles | Sequential, ISO or
Rehab (wave) Flow
Cycles | Not Provided | Not provided. | Similar |
| | Sequential mode that
applies a directional
massage, starting at
the base of the
treated area, and
progresses upwards
towards the torso and
then releases.
Image: Sequential cycle mode | Sequential mode
that applies a
directional massage,
starting at the base
of the treated area,
and progresses
upwards towards
the torso and then
releases.
Image: Sequential cycle mode | | | |
| | ISO mode that
applies a directional
massage to a smaller,
user- selected area.
The first chamber
inflates, and after a
few seconds, the
second chamber
starts to inflate until
both chambers reach
the set pressure. Then
both chambers
deflate, and after a
pause the process
starts again.
Image: ISO cycle mode | ISO mode that
applies a directional
massage to a
smaller, user-
selected area. The
first chamber
inflates, and after a
few seconds, the
second chamber
starts to inflate until
both chambers
reach the set
pressure. Then both
chambers deflate,
and after a pause the
process starts again.
Image: ISO cycle mode | | | |
| | Flow cycles Progress
1: first inflate
Chamber 1 to target
pressure, then hold &
release. then go to
Progress 2. Progress
2: first inflated
Chamber 1 to target | Wave mode: The
first chamber
inflates and after a | | | |
| Item | Proposed Device | Primary Predicate
Device
K211745 | Primary Reference
Device K221189 | Secondary
Reference Device
K062532 | Remark |
| | pressure, then inflate
Chamber 2 and hold
Chamber 1. when
Chamber 2 reach the
target pressure, hold
chamber 1 & 2 for
specified time, then
release totally, then
go to Progress 3
Progress 3: first
inflated Chamber 1 to
target pressure, then
inflate Chamber 2
and hold Chamber 1.
when Chamber 2
reach the target
pressure, hold
chamber 1 & 2, &
start to inflate
Chamber 3, when
Chamber 3 reach to
the target pressure,
then hold chamber 1,
2, 3 for specified
time then release
totally. then go to
Progress 4. | few seconds, the 1st
and 2nd chamber
starts to inflate until
both chambers
reach the set
pressure. Then the
deflation on 1st
chamber, the 2nd
and 3rd chambers
starts to inflate until
the both chambers
reach the set
pressure; then
deflate the 2nd
chambers inflate 3rd
and 4th chambers
until the both
chambers reach the
set pressure.
Image: Wave cycle mode | | | |
| | Progress 4: first
inflated Chamber 1 to
target pressure, then
inflate Chamber 2
and hold Chamber 1.
when Chamber 2
reach the target
pressure, hold
chamber 1 & 2, &
start to inflate
Chamber 3, when
Chamber 3 reach to
the target pressure,
then hold chamber 1,
2, 3,& start to inflate
Chamber 4, when
Chamber 4 reach to
the target pressure,
then hold chamber 1,
2, 3 &4 for specified
time then release
totally. then go back
to Progress 1 again. | Flow cycles
Progress 1: first
inflate Chamber 1
to target pressure,
then hold & release.
then go to Progress
2. Progress 2: first
inflated Chamber 1
to target pressure,
then inflate
Chamber 2 and hold
Chamber 1. when
Chamber 2 reach
the target pressure,
hold chamber 1 & 2
for specified time,
then release totally,
then go to Progress
3 Progress 3: first
inflated Chamber 1
to target pressure,
then inflate
Chamber 2 and hold
Chamber 1. when
Chamber 2 reach
the target pressure, | | | |
| Item | Proposed Device | Primary Predicate
Device
K211745 | Primary Reference
Device K221189 | Secondary
Reference Device
K062532 | Remark |
| | Image: Chamber 1, Chamber 2, Chamber 3
Image: [Illustration of chambers inflating]
Static Cycle
The chambers inflate
one at the time
starting at chamber 1
while maintaining
negative gradient of
compression along
the leg. The pressure
is limited to 20
mmHg to 30 mmHg.
Once inflated, the
chambers do not
deflate during the
treatment. While the
garment is inflated, it
comes in
contact with the legs
to optimize the
treatment of vibration
and infrared LED
light by ensuring
optimal contact with
the leg.
Image: Static Cycle | hold chamber 1 &
2, & start to inflate
Chamber 3, when
Chamber 3 reach to
the target pressure,
then hold chamber
1, 2, 3 for specified
time then release
totally. then go to
Progress 4.
Progress 4: first
inflated Chamber 1
to target pressure,
then inflate
Chamber 2 and hold
Chamber 1. when
Chamber 2 reach
the target pressure,
hold chamber 1 &
2, & start to inflate
Chamber 3, when
Chamber 3 reach to
the target pressure,
then hold chamber
1, 2, 3,& start to
inflate Chamber 4,
when Chamber 4
reach to the target
pressure, then hold
chamber 1, 2, 3 &4
for specified time
then release totally.
then go back to
Progress 1 again.
Image: Chamber 1, Chamber 2, Chamber 3
Image: [Illustration of chambers inflating] | | | |
| Device Pressure
Range | 20 - 100 mmHg,
steps of 5mm Hg | 20 – 100 mmHg | Not provided/Not
applicable | Not provided/not
applicable | SAME |
| Maximum
Device Surface
Temperature | 43.2° C | Not provided/Not
applicable | Less than 40° C | Not provided. | Similar |
| Highest
Measured Skin
Temperature
During
Treatment | 36.8° C | Not provided/Not
applicable | Not provided | Not provided. | Similar |
| Item | Proposed Device | Primary Predicate
Device
K211745 | Primary Reference
Device K221189 | Secondary
Reference Device
K062532 | Remark |
| Wavelengths | 655nm, 850nm | Not provided/Not
applicable | 655nm, 855nm | Not provided. | SAME |
| Treatment Time | 10min - 60min, steps
of 5min for
Pneumatic
Compression
10min - 45min for
Infrared LED | 10min - 90min, step
of 5min | 15 minutes, twice per
day. Total of 210
minutes per week. | Not provided. | Similar |
| Hold time within
cycle | 0 – 10 seconds
depending on the
selected preset. | 2 - 10 seconds | Not Provided/Not
Applicable | Not Provided/Not
Applicable | Similar |
| Pause interval
between cycles | 15 seconds | 10 - 70 seconds | Not Provided/Not
Applicable | Not Provided/Not
Applicable | Similar |
| Mobile
Application | Device does not
connect to a Mobile
Application. | Bluetooth
Communication | Not Provided | Not Provided | Similar |
| Patient Contact | Non-conductive
appliances | Non-conductive
appliances | Not Provided | Not Provided | SAME |
| Garment
Material | Polyether Nylon
Fabric | Polyether Nylon
Fabric | Not Provided | Not Provided | SAME |
| Software/Firmwa
re/
Microprocessor
Control | Microprocessor | Microprocessor | Not Provided | Not Provided | SAME |
| Device Function | Compressor and
valve system which
sequentially inflates
cells of appliance,
Light Emitting
Diodes | Compressor and
valve system which
sequentially inflates
cells of appliance | Light Emitting Diodes | Not Provided | SAME |
8
510(K) PREMARKET NOTIFICATION FOR THERABODY, INC. JetBoots PRO Plus ______________________________________________________________________________________________________________________________________________________________________________
Table 2 Performance Comparison
9
10
11
12
Table 3 Safety Comparison
| Item | Proposed Device | Primary Predicate Device
K211745 | Primary Reference Device K221189 | Secondary Reference Device K062532 | Remark |
|------------------------|---------------------------------------------------------|------------------------------------------------------------------------------------------|-------------------------------------------|------------------------------------|---------|
| Electrical Safety | Complies with IEC 60601-1,
IEC 60601-1-11 | Complies with IEC 60601-1,
IEC 60601-1-11 | Complies with IEC 60601-1, IEC 60601-1-11 | Not Provided. | SAME |
| Photobiological Safety | Complies with IEC 62471
Complies with IEC 60601-2-57 | Does not contain components that required testing to demonstrate Photobiological Safety. | Not Provided | Not Provided. | SAME |
| EMC | Complies with IEC 60601-1-2
ANSI C63.18-2014 | Complies with IEC 60601-1-2 | Complies with IEC 60601-1-2 | Not Provided. | Similar |
13
| Biocompatibility | Complies with ISO
10993-5 and ISO | Complies with ISO
10993-5 and ISO | Complies with ISO
10993-1 and ISO | Not Provided. | SAME |
|-----------------------|-----------------------------------------------|-----------------------------------------------|--------------------------------------|---------------|------|
| | 10993-10
ISO 10993-23 | 10993-10
ISO 10993-23 | 10993-5
ISO 10993-10 | | |
| Label and
Labeling | Conforms to FDA
Regulatory
Requirements | Conforms to FDA
Regulatory
Requirements | Not Provided. | Not Provided. | SAME |
(7) PERFORMANCE DATA:
The following performance data were provided in support of the substantial equivalence determination, Electrical safety and electromagnetic compatibility (EMC) JetBoots PRO Plus passed all electrical safety and EMC tests, Electrical Safety Testing was conducted in accordance with:
- IEC 60601-1:2005, AMD1:2012 + AMD2:2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-6:2010 + A1:2013 + A2:2020, Medical devices – Application of usability engineering to medical devices
- . IEC 60601-1-11:2015, Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- . IEC 60601-2-83:2019, Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
- o IEC 62133-2:2017 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications Part 2: Lithium systems
- the Advancement of Medical Instrumentation for the evaluation of Wireless Coexistence
EMC Testing was conducted in accordance with:
- IEC / EN 60601-1-2:2014-02, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic Disturbances - Requirements and Tests
- o ANSI C63.18-2014
Sterilization & Shelf-life Testing: JetBoots PRO Plus is not sold sterile or ever intended to be sterilized. Therefore, sterilization testing was not necessary to demonstrate the safety or performance of the device. The subject device has a shelf-life of 1000 hours.
14
Biocompatibility Testing:
Cytotoxicity, Irritation and Sensitization testing was conducted to demonstrate the biocompatibility of patient-contacting materials of JetBoots PRO Plus in accordance with:
- ISO 10993-5:2009, biological evaluation of medical devices part 5: tests for in vitro ● cytotoxicity
- ISO 10993-10:2021, biological evaluation of medical devices part 10: tests for skin sensitization
- ISO 10993-23:2021, biological evaluation of medical devices - part 23: tests for skin irritation
Software Verification and Validation Testing
Software Verification and Validation Testing was conducted in accordance with IEC 62304:2006 Medical Device Software - Software Life Cycle Processes.
Animal Study
Animal testing was not required to demonstrate safety and effectiveness of JetBoots PRO Plus
Clinical Studies
Clinical testing was not required to demonstrate the safety and effectiveness of the JetBoots PRO Plus.
Non-Clinical Testing
Device Temperature Range Testing was conducted in accordance with "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Heating and Cooling Devices."
(8) PERFORMANCE TESTING BENCH
The following performance bench testing was conducted:
- Performance test before reliability
- Reliability Bench Test Report
- Performance test after reliability
- Max Pressure Testing for Accuracy During Treatment
- Mechanical Safety Valve Testing
- Air Bladder Testing
Usability Engineering
Usability Study Report, Therabody study TG-RA-Jetboots PRO Plus
15
(9) CONCLUSION:
JetBoots Pro Plus is substantially equivalent to the Primary Predicate Device and the Reference Devices in Indications for Use and technological characteristics. Though minor differences exist between the Proposed, Predicate, and Reference devices, these do not raise questions of safety and effectiveness. Therefore, Therabody's JetBoots PRO Plus is as safe, as effective, and performs as well as the Predicate and Reference Devices.