← Product Code [SGT](/productcode/SGT) · K262788 # Nova HD+ (K262788) _Aura Wellness, LLC · SGT · Aug 31, 2026 · Physical Medicine · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K262788 ## Device Facts - **Applicant:** Aura Wellness, LLC - **Product Code:** [SGT](/productcode/SGT.md) - **Decision Date:** Aug 31, 2026 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 890.5850 - **Device Class:** Class 2 - **Review Panel:** Physical Medicine - **Attributes:** Therapeutic ## Indications for Use The Nova HD+ is indicated: • To temporarily increase local blood circulation in healthy leg muscles • To stimulate healthy muscles in order to improve or facilitate muscle performance ## Device Story Noninvasive physical medicine device; uses electrically generated magnetic fields to stimulate muscles; improves/facilitates muscle performance; increases local blood circulation. System comprises main control unit and five accessory coils (Large Loop, Butterfly Loop, Wings, Half Body Mat, Paddle) for targeted anatomical treatment. Used in home care and clinical settings; operated by patients or professionals. Operator uses 5-button interface to control magnetic pulse generator intensity and treatment duration (1-90 minutes). Microprocessor-controlled firmware manages pulse delivery. Output affects muscle tissue via magnetic field induction; benefits include muscle conditioning and circulation support. ## Clinical Evidence No clinical data. Bench testing only. Performance testing included signal waveform output (volts) and magnetic flux output (mT) measurements across all intensity levels (1-10). Biocompatibility testing performed per ISO 10993-1, -5, and -10. ## Technological Characteristics Microprocessor-controlled powered muscle stimulator; noninvasive magnetic field induction. Main unit: 9.7" x 10.64" x 3.57", 5.6 lbs. Accessories: 5 coils (loops, mat, paddle). Power: 120 Vac, 60 Hz. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 62366-1, IEC 62304. Biocompatibility: ISO 10993 series. Sterilization: Not applicable (reusable, non-disposable). ## Regulatory Identification A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area. ## Predicate Devices - Nova HD+ ([K220938](/device/K220938.md)) - Aura Wave ([K250896](/device/K250896.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} **FDA** U.S. FOOD & DRUG ADMINISTRATION August 31, 2026 Aura Wellness, LLC Scott Blomberg Director of Regulatory 2208 Plantside Dr. Louisville, Kentucky 40299 Re: K262788 Trade/Device Name: Nova HD+ Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: SGT Dated: August 6, 2026 Received: August 6, 2026 Dear Scott Blomberg: 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. 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" U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K262788 - Scott Blomberg Page 2 (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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 Management System Regulation (QMSR) (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-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). {2} K262788 - Scott Blomberg Page 3 Sincerely, # Tushar Bansal -S Tushar Bansal, PhD Acting Assistant Director, Acute Injury Devices Team 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 {3} | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K262788 | ? | | Please provide the device trade name(s). | | ? | | Nova HD+ | | | | Please provide your Indications for Use below. | | ? | | The Nova HD+ is indicated: • To temporarily increase local blood circulation in healthy leg muscles • To stimulate healthy muscles in order to improve or facilitate muscle performance | | | | Please select the types of uses. | ☐ Prescription Use (21 CFR 801 Subpart D) ☑ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | | Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ? | {4} # 510(k) SUMMARY (as required by 21CFR 807.92) # I Submitter Aura Wellness, LLC 2208 Plantside Drive Louisville, KY 40299 Phone: 502-714-1993 Fax: 502-369-5226 Submitter Contact: Scott Blomberg Submission Correspondent: scott@aurawell.com Establishment Registration: 10081462 Submission Date: August 6, 2026 # II Device Proprietary or Trade Name: Nova HD+ Common/Usual Name: Powered Muscle Stimulator Classification Name: Stimulator, Muscle, Powered, For Muscle Conditioning Regulation: 890.5850 Regulatory Class: 2 Product Code: SGT Device Panel: Neurological and Physical Medicine Devices # III Primary Predicate Device Nova HD+ (K220938) Secondary Predicate Aura Wave (K250896) # IV Device Description The Nova HD+ system is a noninvasive physical medicine device that uses electrically generated magnetic fields to stimulate muscles in order to improve and facilitate muscle performance. The Nova HD+ is noninvasive, fully reusable (no disposable components such as electrodes) and have configurations allowing both home care and clinical professional use. In addition to the main control unit, the Nova HD+ has five accessory attachments (coils). The attachments vary in size and form which allows the operator to choose which attachment administers optimal treatment to the desired anatomical part of the body. The device contains firmware that controls the user interface. Through this user interface, the operator controls the magnetic pulse generator intensity and duration of the treatment. Accessories to the device | Name | Description | | | --- | --- | --- | | Large Loop | For treatment of upper back and shoulders, and lower back | Provided with system | | Butterfly Loop | For treatment of knee, ankle, foot, hand, arm and shoulder | Optional accessory | | Wings | For treatment of back, shoulders, and neck | Optional accessory | | Half Body Mat | For treatment of back, lower back, hips, and hamstring muscles | Optional accessory | | Paddle | For treatment of hip, thigh, buttocks, hands, and feet | Optional accessory | {5} # V Indication for Use The Nova HD+ is indicated: - To temporarily increase local blood circulation in healthy leg muscles. - To stimulate healthy muscles in order to improve or facilitate muscle performance. Environments of use: Over the Counter (OTC), both home care and clinical professional use # VI Comparison of Technological Characteristics and Performance with the Predicate Devices Table 1 below provides the summarized substantial equivalence comparison of general intended uses/actions, specific indications for use, equivalence of key clinical and technical features between subject and predicate device, along with a full listing of technical and conformance specifications. Table 1: Comparison of Subject vs. Predicate Devices | | | Nova HD+ Subject Device | Nova HD+ Primary Predicate Device K220938 | Aura Wave Secondary Predicate Device K250896 | | --- | --- | --- | --- | --- | | Classification Code | Regulation Identical Subject and Secondary Predicate Identical | Primary: Powered Muscle Stimulator SGT 890.5850 | Primary: Powered Muscle Stimulator NGX 890.5850 | Primary: Powered Muscle Stimulator SGT 890.5850 | | Indication for Use | Subject and Predicate Similar Subject and Secondary Predicate Identical | The Nova HD+ is indicated: • To temporarily increase local blood circulation in healthy leg muscles. • To stimulate healthy muscles in order to improve and facilitate muscle performance | The Nova HD+ is indicated: • To stimulate healthy muscles in order to improve and facilitate muscle performance | The Aura Wave is indicated: • To temporarily increase local blood circulation in healthy leg muscles. • To stimulate healthy muscles in order to improve and facilitate muscle performance | | Primary Mode of Action | Identical | Non-invasive tissue stimulation via magnetic field induction | Non-invasive tissue stimulation via magnetic field induction | Non-invasive tissue stimulation via magnetic field induction | | Therapy Timer | Subject and Primary Predicate Similar Subject and Secondary Predicate Identical | 1-90 minutes (10 minute default) Recommended treatment time is 10-20 minutes for a single location on the body. | 1-20 minutes (10 minute default) | 1-90 minutes (10 minute default) Recommended treatment time is 10-20 minutes for a single location on the body. | | Model (System) | Similar | Nova HD+ | Nova HD+ | Aura Wave | | Available Accessories | Subject and Primary Predicate Similar Subject and Secondary Predicate Identical | Large Loop Butterfly Loop Wings Half Body Mat Paddle | Large Loop | Large Loop Butterfly Loop Wings Half Body Mat Paddle | {6} | | | Nova HD+ Subject Device | Nova HD+ Primary Predicate Device K220938 | Aura Wave Secondary Predicate Device K250896 | | --- | --- | --- | --- | --- | | Weight | Subject and Primary Predicate Identical | 5.6 pounds (2.5 kg) | 5.6 pounds (2.5 kg) | 8.1 pounds (3.7 kg) | | Dimensions (Main Unit): | Subject and Primary Predicate Identical | 9.7" x 10.64" x 3.57" | 9.7" x 10.64" x 3.57" | 11.9" x 13.7" x 4.6" | | Size of Therapy Area | Subject and Primary Predicate Similar Subject and Secondary Predicate Identical | 50 in² (Paddle) to 573 in² (Wings) | 147.2 in² (Large Loop) | 50 in² (Paddle) to 573 in² (Wings) | | Magnetic Field Output RMS Average | Similar | Up to 3.6 mT | Up to 1.8 mT | Up to 0.19 T | | Maximum Induced Current* | The maximum induced current for the subject device does not raise safety or effectiveness concerns as it falls below the accepted standards for safe operation. In addition, the maximum induced current is similar to the Secondary Predicate device. | 0.063 mA/cm² | 0.039 mA/cm² | 0.084 mA/cm² | | Pulse Repetition Rate | Subject and Primary Predicate Identical | 0.4 to 5.4 Hz | 0.4 to 5.4 Hz | 0.4 to 5.8 Hz | | Pulse Duration | Subject and Primary Predicate Identical | 0.6 to 0.7 mS | 0.6 to 0.7 mS | 0.13 to 0.24 mS | | Power Consumption | Subject and Primary Predicate Identical | 81.6 Watts maximum | 81.6 Watts maximum | 90 Watts maximum | | Input Power | Subject and Primary Predicate Identical | 120 Vac, 60 Hz, 0.68 A | 120 Vac, 60 Hz, 0.68 A | 120 Vac, 50 or 60 Hz, 0.75 A | | Number of Output Channels | Identical | 1 | 1 | 1 | | User Interface | Identical | Simple 5-button interface | Simple 5-button interface | Simple 5-button interface | | Microprocessor controlled | Identical | Yes | Yes | Yes | | Therapy Amplitude Control | Subject and Primary Predicate Identical | Power level 1-10 controlled by operator | Power level 1-10 controlled by operator | Power level 1-20 controlled by operator | | User-controlled therapy start/stop | Identical | Yes | Yes | Yes | | Compliance with voluntary standards | Identical | IEC 60601-1 IEC 60601-1-2 IEC 60601-1-6 IEC 62366-1 IEC 60601-1-11 | IEC 60601-1 IEC 60601-1-2 IEC 60601-1-6 IEC 62366-1 IEC 60601-1-11 | IEC 60601-1 IEC 60601-1-2 IEC 60601-1-6 IEC 62366-1 IEC 60601-1-11 | | Firmware developed per IEC 62304 | Identical | Yes | Yes | Yes | *Induced current measured according to IEC 60601-2-10. {7} ## VII Equivalence Rationale The subject device Nova HD+ and the Primary Predicate device Nova HD+ (K220938) are both noninvasive physical medicine devices that use electrically generated magnetic fields to stimulate muscles and other tissues for a variety of benefits to the patient. Those benefits include a temporary increase in blood circulation in healthy leg muscles, and the stimulation of healthy muscles in order to improve or facilitate muscle performance. Both systems share the following characteristics: - A main unit which is a solid-state microprocessor controlled electronic device and is powered from mains. - Large Loop accessory coil. - Relatively small (< 10 pounds) and can be easily transported. - Tested to applicable safety and EMC standards for both home care and professional use environments. - Operator adjustable therapy timer and adjustable power output. - Identical user interface. - Very similar waveform output in terms of waveform shape and pulse rate. - Similar induced current (estimated for tissue). - Both offer one operating channel. The subject device Nova HD+, and the Secondary Predicate device Aura Wave both offer a variety of accessories to give the user the option of treating either a targeted part of the anatomy with the smaller accessories to large areas of the anatomy such as the back with the largest accessories. The accessories for the subject device and the Secondary Predicate device are identical. ### Non-clinical Testing Performance testing demonstrated that the subject treatment applicator performed equivalent to the Primary Predicate applicator. Testing included: Performance testing involved multiple measurements of: - Signal waveform output (volts) generated from Nova HD+ with its applicators. - Magnetic flux output (mT) generated from the applicator at all signal intensity input levels 1-10. ### Software - All software features documented and tested in accordance with IEC 62304 for 'Moderate' level of concern. ### Electrical / EMC evaluated per - IEC 60601-1 - Medical Electrical Equipment - Part 1: General Requirements for Basic Safety And Essential Performance - IEC 60601-1-2 - Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests - IEC 60601-1-11 - Medical Electrical Equipment - 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 60601-1-6 - Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability - IEC 62366-1 - Medical devices — Part 1: Application of usability engineering to medical devices ### Biocompatibility - ISO 10993-1 - Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process {8} - ISO 10993-5 - Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity - ISO 10993-10 - Biological Evaluation of Medical Devices - Part 10: Tests for Irritation And Skin Sensitization ### Clinical Testing Not applicable. No clinical testing was performed. ### CONCLUSIONS The analysis of the differences between Nova HD+ and the predicate devices does not raise new questions of safety and effectiveness for the subject device. Based on device performance test results, Aura Wellness determines that the Nova HD+ system performs within its design specifications and is substantially equivalent to the predicate devices. The information in this 510(k) submission demonstrates that the Nova HD+ system is substantially equivalent to the predicate devices. --- **Source:** [https://fda.innolitics.com/device/K262788](https://fda.innolitics.com/device/K262788) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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