Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical pressure pulse device and does not mention any AI or ML components or functionalities.

Therapeutic

Yes.
The device's intended use is to provide relief for minor muscle aches and pains, increase local blood circulation, and activate connective tissue, which are all therapeutic functions.

Diagnostic

No

The "Intended Use / Indications for Use" section states the device is for "relief of minor muscle aches and pains, temporary increase in local blood circulation and activation of connective tissue," which are therapeutic, not diagnostic, purposes.

SaMD (Software as a Medical Device)

No

The device description clearly outlines hardware components including a pressure pulse device, handpiece, transmitters, and mentions the use of ultrasound gel. The performance studies also include testing for electrical safety and biocompatibility, which are relevant to hardware.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
VMAP PRO Function: The VMAP PRO is a physical therapy device that applies pressure pulses to the skin for therapeutic purposes (muscle aches, circulation, connective tissue). It interacts directly with the body and does not involve testing bodily specimens.

The description clearly indicates a device for external physical treatment, not for laboratory testing of biological samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The VMAT PRO is intended for relief of minor muscle aches and pains, temporary increase in local blood circulation and activation of connective tissue.

Product codes (comma separated list FDA assigned to the subject device)

ISA

Device Description

The VMAT PRO is a pressure pulse device that creates pneumatically generated pressure pulses caused by compressed air delivering ballistic projectile through a handpiece coming into contact with the skin. VMAT PRO is equipped with one handpieces that includes four transmitters [VAT120 (diameter of 20mm), VAT220 (diameter of 20mm), VAT215 (diameter of 15mm), and VAT 135 (diameter 35mm)] that allow radial treatments, ergonomically designed to allow the user to work in various areas of the body. To facilitate the movement of the transmitter on the skin, and guarantee a correct contact, an ultrasound gel FDA cleared should be used (i.e. Aquasonic 100 Ultrasound Transmission Gel K802146).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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)

Verification and validation activities were successfully completed and establish that the VMAT PRO control unit performs as intended. Testing included the following:
IEC 60601-1:2005 (Third Edition) + A1:2012 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
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
IEC 63045:2020 Ultrasonics -Non-focusing short pressure pulse sources including ballistic pressure pulse sources - Characteristics of fields.

Software verification and validation testing was conducted, and documentation provided in accordance with FDA's Guidance or the Content of Premarket Submissions for Software Contained in Medical Devices.

Biocompatibility: All tissue contacting materials were tested for biocompatibility according to ISO 10993-1:2018 and found to be biocompatible.

Clinical Evidence – N/A. No clinical studies were conducted as part of this submission.

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.

D-Actor 200 Vibration Massage System (K173692)

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.

Aquasonic 100 Ultrasound Transmission Gel K802146

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

Regulation Number and Section

§ 890.5660 Therapeutic massager.

(a)
Identification. A therapeutic massager is an electrically powered device intended for medical purposes, such as to relieve minor muscle aches and pains.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.

Summary

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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 a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 6, 2025

TermoSalud % Aubrey Thompson Regulatory Consultant Hoy and Associates Regulatory Consultants 1830 Bonnie Way Sacramento, California 95825

Re: K243488

Trade/Device Name: Vmat Pro Regulation Number: 21 CFR 890.5660 Regulation Name: Therapeutic Massager Regulatory Class: Class I Product Code: ISA Dated: October 31, 2024 Received: November 12, 2024

Dear Aubrey Thompson:

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 (OS) 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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 medical devices and radiation-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-regulatory

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assistance/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,

Heather L. Dean -S

for Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K243488

Device Name

VMAT PRO

Indications for Use (Describe)

The VMAP PRO is intended for relief of minor muscle aches and pains, temporary increase in local blood circulation and activation of connective tissue.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) Summary VMAT PRO K243488

Applicant	TermoSalud
Address	Ataulfo Friera Tarfe, 8 -33211 Gijón, Spain
Applicant Contact	Cristina Cifuentes Pantoja
Correspondent Contact	Aubrey Thompson, Regulatory Consultant
AubreyThompson@hoyregulatory.com
Preparation Date	February 6, 2025
Device Trade Name	VMAT PRO (K243488)
Device Classification Name	Massager, Therapeutic, Electric
Common Name	Therapeutic electric massager
Regulation Number	21 CFR 890.5660
Product Code	ISA
Regulatory Class	I
Legally Marketed Predicate
Device	D-Actor 200 Vibration Massage System (K173692)

Device Description:

The VMAT PRO is a pressure pulse device that creates pneumatically generated pressure pulses caused by compressed air delivering ballistic projectile through a handpiece coming into contact with the skin. VMAT PRO is equipped with one handpieces that includes four transmitters [VAT120 (diameter of 20mm), VAT220 (diameter of 20mm), VAT215 (diameter of 15mm), and VAT 135 (diameter 35mm)] that allow radial treatments, ergonomically designed to allow the user to work in various areas of the body. To facilitate the movement of the transmitter on the skin, and guarantee a correct contact, an ultrasound gel FDA cleared should be used (i.e. Aquasonic 100 Ultrasound Transmission Gel K802146).

Indications for use:

The VMAT PRO is intended for relief of minor muscle aches and pains, temporary increase in local blood circulation, and activation of connective tissue.

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510(K) Summary VMAT PRO K243488

Substantial Equivalence—Technological Characteristics:

Subject Device	Predicate Device	Comparison
The VMAT PRO is intended for relief of
minor muscle aches and pains, temporary
increase in local blood circulation, and
activation of connective tissue	The D-ACTOR® 200 Vibration Massage System is intended for: Relief of minor
muscle aches and pains, temporary
increase in local blood circulation,
activation of connective tissue	Identical.

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| Technical Comparison | VMAT PRO | D-ACTOR® 200 Vibration
Massage System
(K173692) | Comparison |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Modes of action | HP-AT pressure pulse handpiece | Radial pressure waves, or
extracorporeal pulse
activation respectively | Same |
| Mechanism of action | Pneumatically generated
vibrations | Pneumatically generated
vibrations | Same |
| Type of acoustic wave
generation | Pneumatic/ballistic | Pneumatic/ballistic | Same |
| Pulse repeat rate (1/s) | 1-21 Hz | 1-21 Hz | Same |
| Maximum and
Minimum intensity
setting | 0.5-5.0 bar | 1-5 bar | Very similar- the
pressure on the VMAT
PRO goes slightly
lower than the
predicate device, but
it does not impact the
safety of the device.
Treatment pressure is
adjusted for patient
comfort, so a slightly
lower pressure can be
more comfortable for
patients. |
| Type of application | Continuous vibration at a fixed
frequency | Continuous vibration at a
fixed frequency | Same |
| Driving power | 1-5 bar | 1-5 bar | Same |
| Projectile Mass (g) | 3.1 g | 3.0 g | Same |
| Pulse repeat rate | 1-21Hz | 1-21Hz | Same |
| Number of pulses | Variable | variable | Same |
| | | | |
| Max and Min
displacement of
applicator heads | VAT220:
Max: 1.230 mm
Min: 0.350 mm

VAT215:
Max: 0.320 mm
Min: 0.120 mm

VAT120:
Max: 1.300 mm
Min: 0.700 mm

VAT 135:
Max: 0.760 mm
Min: 0.300 mm | 0.6 – 2.0 mm | Different. There are
different ways of
measuring this
variable and that not
all of them are equally
accurate. In our case,
it has been measured
in a laboratory, using
ultrasound.

The difference in
values is minimal and
does not pose a risk to
the safety of the
equipment and the
user. |
| Pressure | 0.5-5.0 bar (7.25 psi - 72.5psi) | 1-5 bar | Very similar- the
pressure on the VMAT
PRO goes slightly
lower than the
predicate device, but
it does not impact the
safety of the device.
Treatment pressure is
adjusted for patient
comfort, so a slightly
lower pressure can be
more comfortable for
patients. |
| Beam Pressure
Maximum (BPM) | According to IEC 63045 (at 5
bar)
VAT 220: 45.8 mJ
VAT 215: 34 mJ | According to modified
protocols from IEC 61846
N/A | The measurements
taken are different |

7

510(K) Summary VMAT PRO

K243488

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510(K) Summary VMAT PRO K243488 VAT 120: 24 mJ VAT 135: 34 mJ

9

510(K) Summary VMAT PRO

K243488

| Total Derived focal
acoustic pulse energy | N/A | 5bar/6.5mJ
3bar/2.4mJ | because the
measurement for the
acoustic pulse was
conducted per IEC
63045 standards,
which requires Beam
Pressure Maximum
measurements.

The energy values of
the VMAT PRO are
well within the usual
range for pressure
pulse devices. the
difference between
the values of our
VMAT PRO and the
values of D-Actor 200
is due to the terms
used in the standard.

See further
explanation of the
difference in
specifications below. |
|----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Positive derived
acoustic pulse
energy | According to IEC 63045
(measured for VAT220 at 5bar)

VAT 220: 39.9 mJ

VAT 215: 23 mJ

VAT 120: 17 mJ

VAT215: | Values of ultrasonic pulse:
5bar/18.5MPa
3bar/13.4MPa | The difference in these
values is due to
difference in testing
methodology. See
discussion below. |
| | | | |
| | 5 bar: 11.3 MPa
3 bar: 8.1 MPa
VAT120:
5 bar: 6.3 MPa
3 bar: 4.9 MPa
VAT 135:
5 bar: 3.8 MPa
3 bar: 2.8 MPa | | |
| Negative peak
pressure | VAT220:
5 bar: 6.5 MPa
3 bar: 5.1 MPa | Values of ultrasonic pulse:
5bar: 6.8MPa
3bar: 5.0MPa | Same as VAT220. The
510K summary of the
predicate device does
not state which
transmitter was tested
for these values. |
| Derived pulse-
intensity integral
(Energy Flux Density) | VAT220:
5 bar: 0.267 mJ/mm2
3 bar: 0.152 mJ/mm2

VAT215:
5 bar: 0.224 mJ/mm2
3 bar: 0.135 mJ/mm2 | Values of ultrasonic pulse
according to modified
protocols from IEC 61846:
5bar: .284 mJ/mm2
3bar: .176 mJ/mm2 | Different. While the
values are not
identical, they are very
close in to one another
for the VAT220 and
the remaining
transmitters all have |
| | VAT120:
5 bar: 0.252 mJ/mm2
3 bar: 0.187 mJ/mm2

10

11

510(K) Summary VMAT PRO

K243488

12

13

Performance Testing

Verification and validation activities were successfully completed and establish that the VMAT PRO control unit performs as intended. Testing included the following:

IEC 60601-1:2005 (Third Edition) + A1:2012 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance

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

IEC 63045:2020 Ultrasonics -Non-focusing short pressure pulse sources including ballistic pressure pulse sources - Characteristics of fields.

Software verification and validation testing was conducted, and documentation provided in accordance with FDA's Guidance or the Content of Premarket Submissions for Software Contained in Medical Devices.

Biocompatibility

All tissue contacting materials were tested for biocompatibility according to ISO 10993-1:2018 and found to be biocompatible.

Clinical Evidence – N/A. No clinical studies were conducted as part of this submission.

Substantial Equivalence Discussion

Though the measurements in the substantial equivalence table above some differences between the VMAT PRO and the predicate device, the differences are due to different measuring methods. A key parameter to compare is the derived pulse-intensity integral (energy flux density, measured in mJ/mm²). This parameter demonstrates efficacy because the therapeutic effectiveness of pressure pulses depends on whether the energy of the pressure pulse is distributed over a large area or focused on a locally confined treatment zone (focal zone). The measure of energy concentration is obtained by calculating the energy per area (derived pulse-intensity integral) and is obtained after the pulse has stabilized, not at the first impulse or shot.

Test Methods

The performance testing for the predicate device was conducted using modified protocols from the IEC 61846 standard. Testing for the VMAT Pro was conducted to the standard IEC 63045. This resulted in several differences in the measurements taken.

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510(K) Summary VMAT PRO K243488

Devices such as the VMAT PRO do not have a focus, so the term derived focal acoustic pulse energy is not applicable in this case. The term is also not used in IEC 63045, the focus has been replaced by the beam pressure maximum (BPM).

The derived pulse-intensity integral values of the VMAT PRO are within the usual range for pneumatic pressure pulse devices. Therefore, the difference between the values of our VMAT PRO and the values of D-Actor 200 is due to the terms used in the regulations.

Conclusion

The VMAT PRO and D-Actor 200 are identical in their indications for use and similar in their overall design. The key specification to compare, the derived pulse-intensity integral, is nearly identical between the devices. Differences that exist are due to either differences in the method of pressure wave generation, or differences in the test methods used. The differences do not impact the safety or efficacy of the VMAT PRO device and the key comparisons show that the VMAT PRO is substantially equivalent to the predicate device.