JetBoots PRO Plus

K241256 · Therabody, Inc. · IRP · Aug 30, 2024 · Physical Medicine

Device Facts

• Record ID: K241256
• Device Name: JetBoots PRO Plus
• Applicant: Therabody, Inc.
• Product Code: IRP · Physical Medicine
• Decision Date: Aug 30, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5650
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Air compression therapy device; provides graduated pressure to legs via inflatable garments. Input: user-selected compression levels (20-100mmHg) and cycle modes (Sequential, ISO, Static Flow). Operation: console with air pump, valves, and firmware-controlled circuit board inflates four internal overlapping chambers. Includes optional infrared LED (850nm) for therapeutic warming and vibrating pill motors for user experience. Used in home/clinic settings; operated by patient. Output: pneumatic massage, infrared heat, vibration. Benefits: muscle ache relief, improved circulation. Healthcare provider/user monitors output via device interface; output informs therapy duration/intensity adjustments.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including electrical safety (IEC 60601-1, IEC 60601-1-11), EMC (IEC 60601-1-2), photobiological safety (IEC 62471, IEC 60601-2-57), biocompatibility (ISO 10993-5, -10, -23), and performance bench testing (pressure accuracy, mechanical safety, air bladder integrity).

Technological Characteristics

Materials: Polyether Nylon fabric, molded PC+ABS enclosure. Energy: Internal rechargeable battery or 72W DC power adapter (100-240 VAC). Sensing/Actuation: Air pump/compressor, 4-valve system, infrared LEDs (850nm), vibrating motors. Connectivity: Standalone. Sterilization: Non-sterile. Software: Microprocessor-controlled firmware. Standards: IEC 60601-1, IEC 60601-1-11, IEC 60601-2-83, IEC 62133-2, ISO 10993.

Indications for Use

Indicated for temporary relief of minor muscle aches and pains and temporary increase in blood circulation to the legs in healthy individuals.

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

• RecoveryAir PRO (K211745)

Reference Devices

• OLIZ LTB-1000A (K221189)
• ElectroPulse – Pain Relief (K062532)

Submission Summary (Full Text)

{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 ([e-mail]) or phone [phone] 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) |
|------------------------------|
|------------------------------|

K241256

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: [phone] Email: [e-mail] Date prepared: May 9, 2024

#### Application Correspondent:

Contact Person: Gina Walljasper Company: GPW Enterprises, LLC Address: 47 Gatehouse Rd., Bedminster, NJ 07921 Tel: [phone] Email: [e-mail]

#### (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<br>K241256 | Primary Predicate<br>Device K211745 | Primary Reference<br>Device K221189 | Secondary Reference<br>Device K062532 | Remark |
|----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Manufacturer | Therabody, Inc. | Therabody, Inc.<br>(Formerly<br>Theragun, Inc.) | LTBIO Co., Ltd. | Pain Relief<br>Technologies | |
| Product Name | JetBoots PRO Plus | RecoveryAir PRO | OLIZ LTB-1000A | ElectroPulse - Pain<br>Relief | |
| Classification<br>Name | Powered inflatable<br>tube massager | Powered inflatable<br>tube massager | Infrared Lamp | Transcutaneous<br>Electrical Stimulator<br>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<br>510k) | 2 | SAME |
| Indication for<br>Use | JetBoots PRO Plus is<br>an air compression<br>therapy device<br>intended to provide<br>graduated pressure to<br>the legs.<br><br>JetBoots PRO Plus is<br>indicated for the<br>temporary relief of<br>minor muscle aches<br>and pains, and for a<br>temporary increase in<br>blood circulation to<br>the legs in people<br>who are in good<br>health.<br><br>JetBoots PRO Plus<br>simulates kneading<br>and stroking of<br>tissues by using an<br>inflatable garment. | The RecoveryAir<br>PRO is an air<br>compression therapy<br>device intended to<br>provide graduated<br>pressure to<br>compression<br>garments.<br><br>The RecoveryAir<br>PRO is indicated for<br>the temporary relief<br>of minor muscle<br>aches and pains, and<br>for a temporary<br>increase in blood<br>circulation to the<br>treated areas in<br>people who are in<br>good health.<br><br>The RecoveryAir<br>PRO simulates<br>kneading and<br>stroking of tissues<br>by using an<br>inflatable garment. | The OLIZ LTB-<br>1000A is intended to<br>deliver heat in the IR<br>spectrum to provide<br>topical heating for the<br>purpose of elevating<br>tissue temperature; for<br>the temporary relief of<br>minor muscle and joint<br>pain, arthritis and<br>muscle spasm;<br>relieving stiffness;<br>promoting the<br>relaxation of muscle<br>tissue; and to<br>temporarily increase<br>local blood circulation. | TENS: Used for the<br>temporary relief of<br>pain associated with<br>sore and itching<br>muscles in the lower<br>back due to strain<br>from exercise, or<br>normal household and<br>work activities.<br><br>Vibration: Relaxing<br>Muscles and relieving<br>minor aches and<br>pains.<br><br>Heat Lamp: Emits<br>energy at neat infrared<br>frequencies to provide<br>topical heating and to<br>provide temporary<br>relief of minor muscle<br>and joint pain,<br>arthritis and muscle<br>spasm; relieving<br>stiffness, promoting<br>relaxing of muscle<br>tissue, and to<br>temporarily increase<br>local blood<br>circulation. | SAME |
| Prescription/OTC | OTC | OTC | OTC | OTC | SAME |
| Item | Proposed Device | Primary Predicate<br>Device<br>K211745 | Primary Reference<br>Device K221189 | Secondary<br>Reference Device<br>K062532 | Remark |
| Power Source | Power Adapter:<br>AC Input: 100 –<br>240V AC, 50/60Hz,<br>DC Output: 15.0V,<br>4.8A, 72W<br>Or<br>Internal Battery | Power Adapter:<br>AC Input: 100 –<br>240V AC, 50/60<br>Hz, 12V or internal<br>battery | Li-ion batteries<br>(3.7v_1800mA x2) | Not provided. | Similar |
| Dimensions<br>(L*W*H) | Console &<br>Compression boot<br>(Lead or Support,<br>deflated and fully<br>extended):<br>• S-size:<br>36.8in (L) *<br>5.3in (W) *<br>14.8 (H)<br>• M-size:<br>42.9in (L) *<br>5.3in (W) *<br>16.1 (H)<br>• L-size:<br>46.5in (L) *<br>5.3in (W) *<br>16.1 (H) | 8.6in (L) *6.7in (W)<br>*5.1in (H) | Not provided. | Not provided. | Similar |
| Weight | S-size: 6.0lb (per<br>boot)<br>M-size: 6.4lb (per<br>boot)<br>L-size: 6.7lb (per<br>boot) | 4.202 pounds | Not provided. | Not provided. | Similar |
| Housing<br>Materials | Molded PC+ABS<br>Enclosure | Molded ABS<br>Enclosure | Not provided. | Not provided. | Similar |
| Sleeves | Compression boots<br>sleeves attached to<br>consoles. Sleeves<br>(extended) only:<br>S: 80cm (L)* 37.5<br>cm (H)<br>M: 95cm (L)* 41.0<br>cm (H)<br>L: 1050cm (L)* 41.0<br>cm (H) | RecoveryAir<br>Compression Boots<br>95*28.7cm | Not provided. | Not provided. | Similar |
| Number of<br>Chambers | 4 | 4 | Not provided. | Not provided. | SAME |
| Item | Proposed Device | Primary Predicate<br>Device<br>K211745 | Primary Reference<br>Device K221189 | Secondary<br>Reference Device<br>K062532 | Remark |
| Modes | Sequential, ISO, or<br>Static Flow Cycles | Sequential, ISO or<br>Rehab (wave) Flow<br>Cycles | Not Provided | Not provided. | Similar |
| | Sequential mode that<br>applies a directional<br>massage, starting at<br>the base of the<br>treated area, and<br>progresses upwards<br>towards the torso and<br>then releases.<br>Image: Sequential cycle mode | Sequential mode<br>that applies a<br>directional massage,<br>starting at the base<br>of the treated area,<br>and progresses<br>upwards towards<br>the torso and then<br>releases.<br>Image: Sequential cycle mode | | | |
| | ISO mode that<br>applies a directional<br>massage to a smaller,<br>user- selected area.<br>The first chamber<br>inflates, and after a<br>few seconds, the<br>second chamber<br>starts to inflate until<br>both chambers reach<br>the set pressure. Then<br>both chambers<br>deflate, and after a<br>pause the process<br>starts again.<br>Image: ISO cycle mode | ISO mode that<br>applies a directional<br>massage to a<br>smaller, user-<br>selected area. The<br>first chamber<br>inflates, and after a<br>few seconds, the<br>second chamber<br>starts to inflate until<br>both chambers<br>reach the set<br>pressure. Then both<br>chambers deflate,<br>and after a pause the<br>process starts again.<br>Image: ISO cycle mode | | | |
| | Flow cycles Progress<br>1: first inflate<br>Chamber 1 to target<br>pressure, then hold &<br>release. then go to<br>Progress 2. Progress<br>2: first inflated<br>Chamber 1 to target | Wave mode: The<br>first chamber<br>inflates and after a | | | |
| Item | Proposed Device | Primary Predicate<br>Device<br>K211745 | Primary Reference<br>Device K221189 | Secondary<br>Reference Device<br>K062532 | Remark |
| | pressure, then inflate<br>Chamber 2 and hold<br>Chamber 1. when<br>Chamber 2 reach the<br>target pressure, hold<br>chamber 1 & 2 for<br>specified time, then<br>release totally, then<br>go to Progress 3<br>Progress 3: first<br>inflated Chamber 1 to<br>target pressure, then<br>inflate Chamber 2<br>and hold Chamber 1.<br>when Chamber 2<br>reach the target<br>pressure, hold<br>chamber 1 & 2, &<br>start to inflate<br>Chamber 3, when<br>Chamber 3 reach to<br>the target pressure,<br>then hold chamber 1,<br>2, 3 for specified<br>time then release<br>totally. then go to<br>Progress 4. | few seconds, the 1st<br>and 2nd chamber<br>starts to inflate until<br>both chambers<br>reach the set<br>pressure. Then the<br>deflation on 1st<br>chamber, the 2nd<br>and 3rd chambers<br>starts to inflate until<br>the both chambers<br>reach the set<br>pressure; then<br>deflate the 2nd<br>chambers inflate 3rd<br>and 4th chambers<br>until the both<br>chambers reach the<br>set pressure.<br><br>Image: Wave cycle mode | | | |
| | Progress 4: first<br>inflated Chamber 1 to<br>target pressure, then<br>inflate Chamber 2<br>and hold Chamber 1.<br>when Chamber 2<br>reach the target<br>pressure, hold<br>chamber 1 & 2, &<br>start to inflate<br>Chamber 3, when<br>Chamber 3 reach to<br>the target pressure,<br>then hold chamber 1,<br>2, 3,& start to inflate<br>Chamber 4, when<br>Chamber 4 reach to<br>the target pressure,<br>then hold chamber 1,<br>2, 3 &4 for specified<br>time then release<br>totally. then go back<br>to Progress 1 again. | Flow cycles<br>Progress 1: first<br>inflate Chamber 1<br>to target pressure,<br>then hold & release.<br>then go to Progress<br>2. Progress 2: first<br>inflated Chamber 1<br>to target pressure,<br>then inflate<br>Chamber 2 and hold<br>Chamber 1. when<br>Chamber 2 reach<br>the target pressure,<br>hold chamber 1 & 2<br>for specified time,<br>then release totally,<br>then go to Progress<br>3 Progress 3: first<br>inflated Chamber 1<br>to target pressure,<br>then inflate<br>Chamber 2 and hold<br>Chamber 1. when<br>Chamber 2 reach<br>the target pressure, | | | |
| Item | Proposed Device | Primary Predicate<br>Device<br>K211745 | Primary Reference<br>Device K221189 | Secondary<br>Reference Device<br>K062532 | Remark |
| | Image: Chamber 1, Chamber 2, Chamber 3<br>Image: [Illustration of chambers inflating]<br><br>Static Cycle<br>The chambers inflate<br>one at the time<br>starting at chamber 1<br>while maintaining<br>negative gradient of<br>compression along<br>the leg. The pressure<br>is limited to 20<br>mmHg to 30 mmHg.<br>Once inflated, the<br>chambers do not<br>deflate during the<br>treatment. While the<br>garment is inflated, it<br>comes in<br>contact with the legs<br>to optimize the<br>treatment of vibration<br>and infrared LED<br>light by…