ManaSport+

K222098 · Manamed, Inc. · IMI · Mar 8, 2023 · Physical Medicine

Device Facts

• Record ID: K222098
• Device Name: ManaSport+
• Applicant: Manamed, Inc.
• Product Code: IMI · Physical Medicine
• Decision Date: Mar 8, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Apply stationary use of ultrasound to: Generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of pain, the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation. Apply continuous movement of ultrasound for: 1. Pain. 2. Pain relief, muscle spasms, and joint contractures. 3. Relief of pain, muscle spasms, and joint contractures that may be associated with: Adhesive capsulitis, Bursitis with slight calcification, Myositis, Soft tissue injuries, and Shortened tendons due to past injuries and scar tissues. 4. Relief of pain, muscle spasms, and joint contractures resulting from: Capsular tightness, and Capsular scarring. 5. Localized increase in blood flow. 6. Increased range of motion of contracted joint using heat and stretch techniques.

Device Story

ManaSport+ is a portable, rechargeable ultrasonic diathermy device for home or clinical use. It delivers therapeutic deep heat via piezoelectric ultrasound generation (1.5 MHz). The device features a wireless control option via Bluetooth app, though it remains fully functional independently. It includes safety features like automatic no-load trip, automatic shut-off, and user override. Healthcare providers or patients (under prescription) apply the device to the treatment site. The output (deep heat) is intended to relieve pain, muscle spasms, and joint contractures, and increase local circulation. The device is an adaptation of the ManaSport (K210284) with added home-use support and wireless connectivity.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), ultrasonic performance (IEC 60601-2-5), biocompatibility (ISO 10993-5, ISO 10993-10), home healthcare environment requirements (IEC 60601-1-11), and usability (IEC 60601-1-6).

Technological Characteristics

Piezoelectric ultrasound generator using PZT crystal; 1.5 MHz frequency; continuous wave (100% duty cycle); 120/240 VAC or 3.7 VDC battery power. ABS housing. Dimensions: 140x56x24 mm. Connectivity: Bluetooth wireless control. Standards: IEC 60601-1, 60601-1-2, 60601-2-5, 60601-1-11, 60601-1-6. Non-sterile.

Indications for Use

Indicated for patients requiring therapeutic deep heat for relief of pain, muscle spasms, and joint contractures, or localized increase in blood flow. Conditions include adhesive capsulitis, bursitis, myositis, soft tissue injuries, shortened tendons, capsular tightness, and scarring. Suitable for prescription use in home or clinical settings.

Regulatory Classification

Identification

An ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz 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.

Predicate Devices

• ManaSport (K210284)
• sam 2.0 Long Duration Ultrasound System (K191568)

Submission Summary (Full Text)

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March 8, 2023

ManaMed. Inc. % Bill Ouangin Dai Official Correspondent JKH USA, LLC 14271 Jeffrey Rd. #246 Irvine, California 92620

Re: K222098

Trade/Device Name: ManaSport+ Regulation Number: 21 CFR 890.5300 Regulation Name: Ultrasonic diathermy Regulatory Class: Class II Product Code: IMI, PFW Dated: February 8, 2023 Received: February 9, 2023

#### Dear Bill Quanqin Dai:

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 (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 located 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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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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.

# Lauren E. Woodard -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

510(k) Number (if known) K22098

Device Name ManaSport+

Indications for Use (Describe)

Apply stationary use of ultrasound to:

Generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation.

Apply continuous movement of ultrasound for:

1. Pain.

- 2. Pain relief, muscle spasms, and joint contractures.
- 3. Relief of pain, muscle spasms, and joint contractures that may be associated with:
- · Adhesive capsulitis,
- · Bursitis with slight calcification,
- · Myositis,
- · Soft tissue injuries, and
- · Shortened tendons due to past injuries and scar tissues.
- 4. Relief of pain, muscle spasms, and joint contractures resulting from:
- · Capsular tightness, and
- · Capsular scarring.
- 5. Localized increase in blood flow.
- 6. Increased range of motion of contracted joint using heat and stretch techniques.

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

| <span></span> <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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#### 510(k) Summary

This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

#### 1. Submitter's Information

Submitter: ManaMed. Inc. Address: 5240 W. Charleston Blvd. Las Vegas, NV 89146 Date of Preparation: 03/08/2023

#### 2. Subject Device

Trade/Device Name: ManaSport+ 510(k): K222098 Common Name: Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat Review Panel: Physical Medicine Product Code: IMI, PFW Regulation Number: 21 CFR 890.5300 Regulation Name: Ultrasonic diathermy Device Class: II Use: Prescription

#### 3. Predicate device

Primary Predicate Device: ManaSport 510(k) Number: K210284 Clearance Date: April 26, 2022 Submitter: ManaMed, Inc.

Predicate Device: sam 2.0 Long Duration Ultrasound System 510(k) Number: K191568 Clearance Date: March 6, 2020 Submitter: ZetrOZ Systems, LLC

#### 4. Description of Subject Device

The ManaSport+ is an adaptation of the previously cleared ManaSport device, which was cleared under K210284. A wireless control option was added to the ManaSport+ and the subject device was evaluated for home use. As a portable and rechargeable prescriptive device in the home or clinical/hospital setting, the subject device is intended to apply ultrasound to the patient's treatment site for selected medical conditions such as the relief of pain, the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation. Ultrasound can be used to apply therapeutic deep heat for the treatment of selected medical conditions such as soft tissue injuries, shortened tendons due to past injuries and scar tissues, relief of pain, muscle spasms and joint contractures.

## 5. Indications for Use

Apply stationary use of ultrasound to:

Generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of pain, the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation.

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Apply continuous movement of ultrasound for:

- 1. Pain.
- 2. Pain relief, muscle spasms, and joint contractures.
- Relief of pain, muscle spasms, and joint contractures that may be associated with: 3.
- Adhesive capsulitis, ●
- Bursitis with slight calcification, ●
- Myositis, ●
- Soft tissue injuries, and .
- Shortened tendons due to past injuries and scar tissues. ●
- 4. Relief of pain, muscle spasms, and joint contractures resulting from:
- Capsular tightness, and ●
- Capsular scarring. .
- 5. Localized increase in blood flow.
- 6. Increased range of motion of contracted joint using heat and stretch techniques.

#### 6. Summary of Substantial Equivalence

The following Table 1 summarizes the comparison between the subject device and the predicate device, indicating the intended use and technical characteristics of the subject device are substantially equivalent to those of the predicate device.

| Parameter &<br>Predicate Device(s) | Subject Device | Primary Predicate Device | Predicate Device | Equivalence |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| 510(k)/PMA Number | K222098 | K210284 | K191568 | N/A |
| Submitter<br>/Manufacturer | ManaMed, Inc | ManaMed, Inc. | ZetrOZ Systems, LLC | N/A |
| Device Name/Model | ManaSport+ | ManaSport | sam 2.0 Long Duration Ultrasound<br>System | N/A |
| Product Code | IMI, PFW | IMI, PFW | PFW | Identical |
| Parameter & Predicate<br>Device(s) | Subject Device | Primary Predicate Device | Predicate Device | Equivalence |
| 510(k)/PMA Number | K222098 | K210284 | K191568 | N/A |
| Submitter<br>/Manufacturer | ManaMed, Inc | ManaMed, Inc. | ZetrOZ Systems, LLC | N/A |
| Device Name/Model | ManaSport+ | ManaSport | sam 2.0 Long Duration Ultrasound<br>System | N/A |
| Product Code | IMI, PFW | IMI, PFW | PFW | Identical |
| Indications for Use | Apply stationary use of ultrasound<br>to:<br>Generate deep heat within body<br>tissues for the treatment of selected<br>medical conditions such as the<br>relief of pain, the relief of muscle<br>spasms, the treatment of joint<br>contractures, and the local increase<br>in circulation.<br>Apply continuous movement of<br>ultrasound for:<br>Pain.<br>1.<br>2.<br>Pain relief, muscle<br>spasms, and joint contractures.<br>3.<br>Relief of pain, muscle<br>spasms, and joint contractures that<br>may be associated with:<br>Adhesive capsulitis. | Apply stationary use of ultrasound<br>to:<br>Generate deep heat within body<br>tissues for the treatment of selected<br>medical conditions such as the<br>relief of pain, the relief of muscle<br>spasms, the treatment of joint<br>contractures, and the local increase<br>in circulation.<br>Apply continuous movement of<br>ultrasound for:<br>1.<br>Pain.<br>2.<br>Pain relief, muscle<br>spasms, and joint contractures.<br>Relief of pain, muscle<br>3.<br>spasms, and joint contractures that<br>may be associated with:<br>Adhesive capsulitis. | The sam 2.0 Long Duration Ultrasound<br>Device is intended for home use to<br>apply ultrasonic energy to generate deep<br>heat within body tissues for the<br>treatment of selected medical conditions<br>such as the relief of pain, the relief of<br>muscle spasms, the treatment of joint<br>contractures, and the local increase in<br>circulation. | Identical |

Table 1. Comparison between the subject device and the predicate device

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| Bursitis with slight calcification, Myositis, Soft tissue injuries, and Shortened tendons due to past injuries and scar tissues. 4. Relief of pain, muscle spasms, and joint contractures resulting from: Capsular tightness, and Capsular scarring. 5. Localized increase in blood flow. | Bursitis with slight calcification, Myositis, Soft tissue injuries, and Shortened tendons due to past injuries and scar tissues. 4. Relief of pain, muscle spasms, and joint contractures resulting from: Capsular tightness, and Capsular scarring. 5. Localized increase in blood flow. |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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| | 6. Increased range of motion of contracted joint using heat and stretch techniques. | 6. Increased range of motion of contracted joint using heat and stretch techniques. | | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Users | Health Care Professionals and lay users (under prescription) | Not Publicly Available | Health Care Professionals and lay users (under prescription) | Identical | |
| Prescription or OTC | Prescription | Not Publicly Available | Prescription | Identical | |
| Power Source(s) | 120/240 Vac with 5Vdc Input and rechargeable 3.7Vdc battery | Not Publicly Available | 120/240 VAC with 5V DC Input Power Jack and Lithium Battery Powered | Identical | |
| Number of Output | 1 | Not Publicly Available | 1-2 | Identical | |
| Software/Firmware/Microprocessor Control? | Yes | Not Publicly Available | Yes | Identical | |
| Automatic No-Load Trip? | Yes | Not Publicly Available | Not Publicly Available | Identical | |
| Automatic Shut Off? | Yes | Not Publicly Available | Not Publicly Available | Identical | |
| User Override Control? | Yes | Not Publicly Available | Not Publicly Available | Identical | |
| Indicator Display: | On/Off Status? | Yes | Not Publicly Available | Not Publicly Available | Identical |
| | Low Battery? | Yes | Not Publicly Available | Not Publicly Available | Identical |
| | Voltage / Current Level? | Yes | Not Publicly Available | Not Publicly Available | Identical |
| | Timer Range (minutes) | 0-20 | Not Publicly Available | 0-240 | Identical or similar. This does not affect the safety or effectiveness. |
| | Compliance with Voluntary Standards? | Yes | Not Publicly Available | Yes | Identical |
| | Biocompatibility? | Yes | Not Publicly Available | Yes | Identical |
| Sterility | | Non-Sterile | Not Publicly Available | Non-sterile | Identical |
| Housing construction material | | ABS | Not Publicly Available | ABS | Identical |
| Console/Generator Dimensions (mm) [L x W x H] | | 140×56×24 | Not Publicly Available | 61×70.9×18.8 | Identical or similar. This does not affect the safety or effectiveness. |
| Console/Generator Weight (kg) | | 0.13 | Not Publicly Available | 0.01 | Identical or similar. This does not affect the safety or effectiveness. |
| Treatment head dimensions (mm) [L x W x H] | | 30 x 30 x 12 | Not Publicly Available | 38.1 x 33 x 11.4 | Identical or similar. This does not affect the safety or effectiveness. |
| Treatment Head Weight (kg) | | 0.031 | Not Publicly Available | 0.10 | Identical or similar. This does not affect the safety or effectiveness. |
| Functions and design | | Ultrasound | Not Publicly Available | Ultrasound | Identical |
| Frequency (MHz) | | 1.5 | Not Publicly Available | 3 | Identical or small. The frequency of the subject device is identical to that of the primary predicate device, and smaller than that of the predicate device. Therefore, the frequency does not affect the safety or effectiveness. |
| | Leakage current | <0.3mA | Not Publicly Available | 0.3mA | Identical |
| | Crystal material | PZT | Not Publicly Available | Lead Zirconate-Titanate | Identical |
| | Technology of Ultrasound generation | Piezoelectric | Not Publicly Available | Piezoelectric | Identical |
| | Output Mode | Continuous Wave - 100% duty cycle | Not Publicly Available | Continuous Wave - 100% duty cycle | Identical |
| | | | | | |
| Ratio of temporal<br>maximum output<br>power to the output<br>power | 1:1 | Not Publicly Available | Not Publicly Available | Identical | |
| Deviation | $\pm$ 20% | Not Publicly Available | $\pm$ 20% | Identical | |
| | | | | | |
| Maximum Value of the<br>Output Power (W<br>$\pm$ 20%) | 0.60 | Not Publicly Available | Single Applicator: 0.65W $\pm$ 20%<br>Dual Applicator:<br>1.3W $\pm$ 20% | Identical or similar. Therefore, the<br>maximum power does not affect the<br>safety or effectiveness. | |
| Temporal average power<br>(W $\pm$ 20%) | 0.60 | Not Publicly Available | Not Publicly Available | Identical or similar. Therefore, the<br>temporal average power does not affect<br>the safety or effectiveness. | |
| Maximum value of the<br>effective intensity (W/cm²<br>$\pm$<br>20%) | 0.16 | Not Publicly Available | 0.264 | Identical or similar. Therefore, the<br>maximum effective intensity does not<br>affect the safety or effectiveness. | |
| Beam Maximum<br>Intensity and Accuracy<br>(W/cm² $\pm$ 20%) | 0.16 | Not Publicly Available | 0.132 | Identical or similar. Therefore, the<br>bean maximum intensity does not affect<br>the safety or effectiveness. | |
| Duty factor | 100% | Not Publicly Available | 100% | Identical | |
| Beam Type | Collimated | Not Publicly Available | Divergent | Identical or similar. This does not affect<br>the safety or effectiveness. | |
| Applicator size | Area: 3.9 or 5 cm² | Not Publicly Available | Up to two circular Applicators One<br>Applicator: 5 cm2<br>Two Applicators : 10 cm2 | Identical | |
| Maximum patient contact<br>surface temperature of the<br>treatment head under<br>simulated or actual use<br>conditions for all<br>operating conditions<br>(continually operated for<br>maximum<br>treatment time) (°C) | Meets IEC 60601-2-5,<br>section 201.11 Protection against<br>excessive temperature and other<br>HAZARDS. | Not Publicly Available | 44 °C | Identical | |
| Peak Temperature Rise<br>vs. Time and Tissue<br>Depth to Maximum<br>Treatment Time (for fixed<br>Treatment Head<br>Placement) (°C) | 7.6°C at 1 cm<br>3.3°C at 2 cm<br>1.4°C at 3 cm<br>Max treatment time: 20 min | Not Publicly Available | 8°C at 1 cm 6°C at 3 cm 3°C at 5 cm<br>Max treatment time: 4 hours | Identical or similar. This value of the<br>subject device is identical to that of the<br>primary predicate device, and smaller<br>than that of the predicate device.<br>Therefore, it does not affect<br>the safety or effectiveness. | |
| Beam Non-Uniformity<br>Ratio | 4 $\pm$ 20% | Not Publicly Available | <5 $\pm$ 20% | Identical or similar. Therefore, the beam<br>non-uniformity ratio does not<br>affect the safety or effectiveness. | |
| Effective Radiating Area<br>(cm2) | 3.9 or 5 $\pm$ 20% | Not Publicly Available | One: 6 cm2 Two:12 cm2<br>$\pm$ 20% | Identical or smaller. Therefore, the<br>effective radiating area does not<br>affect the safety or effectiveness. | |
| Electrical Safety<br>Standards Compliance | IEC 60601-1<br>IEC 60601-2-5<br>IEC 60601-1-2<br>IEC 60601-1-11<br>IEC 60601-1-6<br>Wireless Coexistence Cybersecurity | Not Publicly Available | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11 | Identical or similar with IEC 60601- 1-<br>11 and IEC 60601-1-6 added…