(268 days)
The VIVY™ is to be used to generate deep heat within body tissues for the treatment of medical conditions such as relief of pain and muscle spasms.
The Vivy is used for diathermic heating of tissue. It consists of a compact, low-power, radio frequency (RF) generator contained within a garment to deliver therapeutic warming to injured tissues to facilitate the healing process. The power level and treatment time are adjustable. The device treatment is intended to be self-administered in the home.
Electronic circuitry in the power generator components generates a radiofrequency (RF) signal at a frequency of 13.56 Megahertz (MHz). The radiofrequency signal is delivered to the heat applicator garment that uses induction coil (magnetic field) technology to produce electromagnetic fields external to the applicator. This energy is converted into heat by electromagnetically resistant body tissues. Continuous shortwave diathermy (CSWD) with the ViaTherm Vivy System produces therapeutic warming from within the tissues.
The power generator consists of a battery pack, voltage regulators, a power control and analog sensor module, and an RF generator. A shielded cable with 50 Ohms impedance connects the power generator to the heat applicator garment. The electrode consists of two flat spirals incorporated into the applicator garment. The spirals are each tuned to 50 Ohms. The power from the generator is split and sent to the two spirals, one of which is driven 180 degrees out of phase from the other.
The Vivy contains the following components:
- Rechargeable power generator containing a battery pack, regulator, power control, and analog sensor module
- Garment belt
- Heat applicator with dual RF coils
- USB cable
- Garment cable
N/A
FDA 510(k) Clearance Letter - ViaTherm ViVY System
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
November 5, 2025
ViaTherm Therapeutics, LLC
℅ Sharon Bishop
Director, Regulatory Affairs
Graematter, Inc.
1324 Clarkson Clayton Ctr #332
St. Louis, Missouri 63011
Re: K250376
Trade/Device Name: ViVY
Regulation Number: 21 CFR 890.5290
Regulation Name: Shortwave Diathermy
Regulatory Class: Class II
Product Code: IMJ
Dated: October 6, 2025
Received: October 6, 2025
Dear Sharon Bishop:
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.
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K250376 - Sharon Bishop Page 2
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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K250376 - Sharon Bishop Page 3
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,
Amber T. Ballard -S
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
Page 4
FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
510(k) Number (if known)
K250376
Device Name
VIVY™
Indications for Use (Describe)
The VIVY™ is to be used to generate deep heat within body tissues for the treatment of medical conditions such as relief of pain and muscle spasms.
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)
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:
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Page 5
ViaTherm ViVY™ 510(k) Summary
K250376 ViaTherm ViVY System November 5, 2025
Submitter's Information
Contact: Maria Fattore
ViaTherm Therapeutics, LLC
209 4th Avenue
Pittsburgh, PA 15222
Contact: Sharon Bishop
Graematter, Inc.
1324 Clarkson Clayton Ctr #332
Ballwin, MO 63011
Phone: 919-724-8978
Date: November 5, 2025
Classification
The classification for the new device is listed below.
| 21 CFR Reference | Product Code | Class | Generic Device Name | Classification Description |
|---|---|---|---|---|
| §890.5290 | IMJ | II | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | Shortwave diathermy |
New Device
The new device's indications for use are listed in the table below.
| Device Name | Indications for Use |
|---|---|
| Vivy™ | The Vivy is to be used to generate deep heat within body tissues for the treatment of medical conditions such as relief of pain and muscle spasms. |
Predicate Device
The predicate device for the Vivy is shown in the table below.
| K Number | Product Code | Predicate Device Name | Indications for Use |
|---|---|---|---|
| K173300 | IMJ | ViaTherm BOOST Diathermy System | To generate deep heating within body tissues for the treatment of conditions such as relief of pain and muscle spasms. |
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K250376 ViaTherm ViVY System November 5, 2025
ViaTherm ViVY™ 510(k) Summary, Continued
Device Description
The Vivy is used for diathermic heating of tissue. It consists of a compact, low-power, radio frequency (RF) generator contained within a garment to deliver therapeutic warming to injured tissues to facilitate the healing process. The power level and treatment time are adjustable. The device treatment is intended to be self-administered in the home.
Electronic circuitry in the power generator components generates a radiofrequency (RF) signal at a frequency of 13.56 Megahertz (MHz). The radiofrequency signal is delivered to the heat applicator garment that uses induction coil (magnetic field) technology to produce electromagnetic fields external to the applicator. This energy is converted into heat by electromagnetically resistant body tissues. Continuous shortwave diathermy (CSWD) with the ViaTherm Vivy System produces therapeutic warming from within the tissues.
The power generator consists of a battery pack, voltage regulators, a power control and analog sensor module, and an RF generator. A shielded cable with 50 Ohms impedance connects the power generator to the heat applicator garment. The electrode consists of two flat spirals incorporated into the applicator garment. The spirals are each tuned to 50 Ohms. The power from the generator is split and sent to the two spirals, one of which is driven 180 degrees out of phase from the other.
The Vivy contains the following components:
- Rechargeable power generator containing a battery pack, regulator, power control, and analog sensor module
- Garment belt
- Heat applicator with dual RF coils
- USB cable
- Garment cable
Page 7
K250376 ViaTherm ViVY System November 5, 2025
ViaTherm ViVY™ 510(k) Summary, Continued
Characteristics
The table below lists the attributes and characteristics for the new and predicate.
| Attribute | New Device ViaTherm ViVy System | Proposed Predicate ViaTherm BOOST K173300 |
|---|---|---|
| Intended Use/ Indications For Use | The Vivy is to be used to generate deep heat within body tissues for the treatment of medical conditions such as relief of pain and muscle spasms. | To generate deep heating within body tissues for the treatment of conditions such as relief of pain and muscle spasms. |
| Trade/Device Name | Vivy | ViaTherm BOOST System |
| Regulation Number | 21 CFR 890.5290 | 21 CFR 890.5290 |
| Regulation Name | Shortwave Diathermy Device | Shortwave Diathermy Device |
| Product Code | IMJ | IMJ |
| Target Population | Adults (not to be used on children) whose medical conditions would be treated, in whole or in part, with therapeutic warmth. Some examples of these types of medical conditions are as follows: pain and swelling in soft tissue injuries; muscle spasms or pain due to injury or over-training. | Adults (not to be used on children) whose medical conditions would be treated, in whole or in part, with therapeutic warmth. Some examples of these types of medical conditions are as follows: pain and swelling in soft tissue injuries; muscle spasms or pain due to injury or over-training. |
| Intended Environment For Use | OTC device intended for use by patients in non-clinical environments, including the home | OTC device intended for use by patients in non-clinical environments, including the home |
| Design | User-friendly device designed with safety mechanisms that enable it to | User-friendly device designed with safety mechanisms that enable it to |
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K250376 ViaTherm ViVY System November 5, 2025
| Attribute | New Device ViaTherm ViVy System | Proposed Predicate ViaTherm BOOST K173300 |
|---|---|---|
| be effectively and safely operated by a non-technical adult in non-clinical environments, including the home setting. | be effectively and safely operated by a non-technical adult in non-clinical environments, including the home setting. | |
| Mechanism of Action | Deep heating of tissue by therapeutic application of radio frequency electrical currents | Deep heating of tissue by therapeutic application of radio frequency electrical currents |
| Anatomical Site Locations | Multi-use therapy garment for target location areas: Arm, back, shoulder, leg, foot. Initial release for lower back garment. | Multi-use therapy garment for target location areas of 5 to 18 square inches: Arm (e.g. bicep, wrist, forearm), back, shoulder, leg (e.g. thigh, knee, calf), foot. |
| Treatment time | Software selection 45 minutes | 40 minutes |
| Available Warming Control | Software selection 0, 50, and 100% | Single setting. Not adjusted by patient. |
| Thermal performance | Achieves 4°C temperature rise at 40 minutes | Achieves 4°C temperature rise at 25 minutes |
| Materials | Rechargeable power generator Heat applicator with dual RF coils USB cable Garment cable Charge adapter Garment Belt Material: • Wrap Lock by BeoCare, a Nylon and polyester blend medical grade fabric • TexacroTM Velcro fastener | Generator Charger Cord Therapy Garment Material: • FuturoTM by 3M, composed of polyurethane foam, nylon, polyester, polyethylene, and spandex • Velcro Extender Strap Patient Interface – 100% cotton pad |
| Safety Factors | The device treatment is intended to be self-administered in the home. The device is battery operated. It | The device treatment is intended to be self-administered in the home. The device is battery |
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K250376 ViaTherm ViVY System November 5, 2025
| Attribute | New Device ViaTherm ViVy System | Proposed Predicate ViaTherm BOOST K173300 |
|---|---|---|
| contains circuit boards that determine if the garment is making sufficient contact with the user, and if so, will output the designated power. The treatment time is based on the life of the battery, preventing the user from over treating. | operated. It contains circuit boards that determine if the garment is making sufficient contact with the user, and if so, will output the designated power. The treatment time is based on the life of the battery, preventing the user from over treating. | |
| Use environment | Designed for OTC use by a non-technical person | Designed for OTC use by a non-technical person |
| Operating Frequency | 13.56 MHz | 13.56 MHz |
| RF Power | 10 watts | 5 watts |
| Duty Cycle | Continuous Wave | Continuous Wave |
| RF Connector | BNC | BNC |
| Impedance | 50 Ohms nominal | 50 Ohms nominal |
| Load Standing Wave Ratio | 3.0:1 max | 3.0:1 max |
| Batteries | Lithium-ion – 3x3.6V, 3200 mAh. | Ni-MH AA – 1.2V x4 (4.8V), 2000 mAh |
| Weight | Approximately 4 lbs. | Approximately 26 ozs. |
| Size | 8.5" x 9.75" x 5" | 2.25" x 4.875" x 6.5" |
| Sterility | Non-sterile | Non-sterile |
| Operating Temperatures | Operating: 59 to 104 degrees F (15 to 40 degrees C) at relative humidity of 30%- | Operating: 59 to 104 degrees F (15 to 40 degrees C) at relative humidity of 30%-90% (non- |
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K250376 ViaTherm ViVY System November 5, 2025
| Attribute | New Device ViaTherm ViVy System | Proposed Predicate ViaTherm BOOST K173300 |
|---|---|---|
| 90% (non-condensing) and pressure of 700-1060 hPa. | condensing) and pressure of 700-1060 hPa. | |
| Storage Temperatures | Storage: 50 to 140 degrees F (10 to 60 degrees C) at relative humidity of 15%-90% (noncondensing) and pressure of 700-1060 hPa. | Storage: 50 to 140 degrees F (10 to 60 degrees C) at relative humidity of 15%-90% (noncondensing) and pressure of 700-1060 hPa. |
| Radiation Safety | Established | Established |
| RF Shielding | Yes | Yes |
| Designed to meet Electrical Safety Standards | IEC 60601-1 IEC 60601-1-2 IEC 60606-1-6 IEC 60601-1-11 IEC TR 60601-4-2 ANSI AAMI HA60601-1-11 AIM 7351731 | IEC 60601-1 IEC 60601-1-2 IEC 60606-1-6 IEC 60601-1-11 |
| Coil design | Two flat spiral coils embedded in a fabric garment | Two flat spiral coils embedded in a fabric garment |
Continued on next page
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K250376 ViaTherm ViVY System November 5, 2025
ViaTherm ViVY™ Summary, Continued
Discussion
The ViVy System and the predicate device (BOOST System) is intended to deliver deep heating to tissues for the purpose of generating deep heating, relieving pain, and treatment of muscle spasms.
All devices are designed to be used by non-technical individuals.
Induction coil diathermy is utilized by both the subject and predicate device. The shortwave diathermy devices use a radiofrequency (RF) signal that is generated by electronic circuitry at 13.56 MHZ to induce electrical currents and voltages in body tissues. The radiofrequency is delivered to an applicator that produces electromagnetic fields external to the applicator. Electric and magnetic fields are induced in body tissues by the applicator. The induced flow of RF electric current in tissue induces heating.
Vivy operates at 10W. This power level is higher than BOOST, but bench temperature testing demonstrates that body tissues remain within a safe therapeutic range.
The subject and predicate devices are based on the following same technological elements:
- Radiofrequency (RF) signal generator that produces a continuous power
- Control circuitry that manipulates the operating parameters of the system
- Patient applicator (garment)
- Portable design
- Rechargeable battery
Continued on next page
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K250376 ViaTherm ViVY System November 5, 2025
ViaTherm ViVY™ Summary, Continued
Performance Testing
The following tests were performed to verify the safety and effectiveness of the Vivy device.
- ASCA Safety Testing
- IEC 60601-1-2:2014+A1:2020
- IEC TR 60601-4-2:2016
- IEC 60601-1 Edition 3.2 2020-08 Consolidated Version
- ANSI AAMI HA60601-1-11:2015 (including AMD1:2021)
- ASCA EMC testing
- Output Power Adjustment Testing
- Electrical Safety, EMC, and Environmental Testing
- Shipping tests
- Usability
- Primary Label and Device Markings
- Instructions for Use Warnings
- Instructions for Use Tasks
Clinical Testing
Twelve volunteer subjects (4 male; 8 female) were recruited and participated in a study to investigate tissue temperature changes during continuous shortwave diathermy within the thigh muscle.
Characteristics of the subjects:
- Average age was 23+3.4 years.
- Height was 164.9+7.2cm.
- Weight 71+13.2kg.
The maximum temperature rise achieved:
- Skin surface was 8.46+2.2°C at 20 minutes
- 1cm depth (superficial tissue) was 3.34+1.5°C at 35 minutes
- 2 cm depth (deep tissue) was 1.61+0.81°C at 40 minutes
Continued on next page
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K250376 ViaTherm ViVY System November 5, 2025
ViaTherm ViVY™ 510(k) Summary, Continued
Conclusion
The preclinical and clinical performance of the Vivy System demonstrates that it is substantially equivalent to the predicate device. The ViVy System has the same intended use and similar indications, technological characteristics, and principles of operation as its predicate device. Both ViVy and BOOST are indicated for over-the-counter use. The minor difference in the battery (rechargeable for Vivy) as compared to the predicate raises no new issues of safety or effectiveness.
Based on the technical characteristics and the results of the performance testing, the ViVy System is substantially equivalent to the predicate.
§ 890.5290 Shortwave diathermy.
(a)
Shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. A shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body electromagnetic energy in the radiofrequency (RF) bands of 13.56 megahertz (MHz) or 27.12 MHz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.(2)
Classification. Class II (performance standards).(b)
Nonthermal shortwave therapy —(1)Identification. A nonthermal shortwave therapy is a prescription device that applies to the body pulsed electromagnetic energy in the RF bands of 13.56 MHz or 27.12 MHz and that is intended for adjunctive use in the palliative treatment of postoperative pain and edema of soft tissue by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.(2)
Classification: Class II (special controls). The device is classified as class II. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible.
(ii) Appropriate analysis/testing must demonstrate that the device is electrically safe and electromagnetically compatible in its intended use environment.
(iii) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Non-clinical performance testing must characterize the output waveform of the device and demonstrate that the device meets appropriate output performance specifications. The output characteristics and the methods used to determine these characteristics, including the following, must be determined:
(A) Peak output power;
(B) Pulse width;
(C) Pulse frequency;
(D) Duty cycle;
(E) Characteristics of other types of modulation that may be used;
(F) Average measured output powered into the RF antenna/applicator;
(G) Specific absorption rates in saline gel test load or other appropriate model;
(H) Characterization of the electrical and magnetic fields in saline gel test load or other appropriate model for each RF antenna and prescribed RF antenna orientation/position; and
(I) Characterization of the deposited energy density in saline gel test load or other appropriate model.
(iv) A detailed summary of the clinical testing pertinent to use of the device to demonstrate the effectiveness of the device in its intended use.
(v) Labeling must include the following:
(A) Output characteristics of the device;
(B) Recommended treatment regimes, including duration of use; and
(C) A detailed summary of the clinical testing pertinent to the use of the device and a summary of the adverse events and complications.
(vi) Nonthermal shortwave therapy devices marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with these special controls.