BTL-094

K221865 · BTL Industries, Inc. · ISA · Apr 14, 2023 · Physical Medicine

Device Facts

• Record ID: K221865
• Device Name: BTL-094
• Applicant: BTL Industries, Inc.
• Product Code: ISA · Physical Medicine
• Decision Date: Apr 14, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5660
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

BTL-094 is indicated to be used for: - Relief of minor muscle aches and pains. - Temporary increase in local blood circulation. - Activation of connective tissue.

Device Story

BTL-094 is a non-invasive therapeutic device using acoustic waves to stimulate local biological responses in tissue. It generates extracorporeally induced massage pulses via a piezo transducer and coupling pad. The device features a main unit with a color touch screen for parameter adjustment (intensity, frequency, number of shocks) and a secondary screen on the applicator for status monitoring. It is operated by a clinician in a clinical setting. The device provides continuous vibration or single pulse modes. By delivering acoustic pressure waves, it aims to relieve muscle aches, increase circulation, and activate connective tissue, assisting in physical therapy and pain management.

Clinical Evidence

No clinical data. Bench testing only, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), usability (IEC 60601-1-6), and biocompatibility (ISO 10993-1, 5, 10).

Technological Characteristics

Non-invasive therapeutic massager; piezoelectric transducer with acoustic lens; coupling gel pads; 100-240V AC power; 1-25 Hz frequency; 35 mm max penetration depth; 0.01-0.11 mJ/mm2 energy flow density. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-36, ISO 14971, and ISO 10993 series. Software lifecycle per IEC 62304.

Indications for Use

Indicated for relief of minor muscle aches and pains, temporary increase in local blood circulation, and activation of connective tissue in patients requiring therapeutic massage.

Regulatory Classification

Identification

A therapeutic massager is an electrically powered device intended for medical purposes, such as to relieve minor muscle aches and pains.

Predicate Devices

• D-Actor 200 (K173692)
• DolorClast® Radial (K220538)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 14, 2023

BTL Industries Inc. David Chmel VP of Operations 362 Elm Street Marlborough, Massachusetts 01752

Re: K221865

Trade/Device Name: BTL-094 Regulation Number: 21 CFR 890.5660 Regulation Name: Therapeutic Massager Regulatory Class: Class I Product Code: ISA Dated: March 20, 2023 Received: March 20, 2023

Dear David Chmel:

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.

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

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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 (OS) 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,

# 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

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## Indications for Use

510(k) Number (if known) K221865

Device Name BTL-094

Indications for Use (Describe) BTL-094 is indicated to be used for:

- Relief of minor muscle aches and pains.
- Temporary increase in local blood circulation.
- Activation of connective tissue.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of a blue geometric design on the left and the text "BTL Industries" on the right. The geometric design is made up of three squares, each nested inside the other.

## 510(k) Summary

## General Information

| Sponsor: | BTL Industries, Inc.<br>362 Elm Street<br>Marlborough, MA 01752<br>Tel: [phone]<br>Fax: [phone] |
|------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Applicant: | BTL Industries, Inc.<br>362 Elm Street<br>Marlborough, MA 01752<br>Tel: [phone]<br>Fax: [phone] |
| Contact Person: | David Chmel<br>BTL Industries, Inc.<br>[e-mail] |
| Summary Preparation<br>Date: | April 14, 2023 |

## Device Name

| Trade/Proprietary Name: | BTL-094 |
|------------------------------|--------------------------|
| Primary Classification Name: | Therapeutic Massager |
| Common/Usual Name: | Therapeutic Massager |
| Classification Regulation: | 21 CFR 890.5660, Class I |
| Classification Product Code: | ISA |

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## Legally Marketed Predicate Device

The BTL-094 is a state-of-the-art device substantially equivalent to the following products, which are already cleared for distribution in the USA under the following 510(k) Premarket Notification number:

- D-Actor 200 (K173692) ●
- DolorClast® Radial (K220538) .

## Product Description

The BTL-094 is a non-invasive therapeutic device, which uses acoustic waves in order to stimulate a local biological response in the treated tissue.

The BTL-094 generates extracorporeally induced massage pulses to stimulate a local biological response in the treated tissue. The main source of acoustic waves is a piezo transducer inside the applicator. The energy transfer from the piezo transducer to the treated tissue is realized via coupling pad.

The main unit is equipped with a color touch screen, which considerably simplifies its operation. The onscreen information guides the user step through the entire therapy process. A secondary screen is placed on the applicator for the presentation of the actual state of main therapy parameters. The therapeutic parameters are adjustable via touch-screen, buttons and knob. The user is able to set following therapy parameters: intensity, frequency and number of shocks.

The mechanism of action and technological similarities and differences between the BTL-094 device and the predicate devices are described below in the comparison table. The differences do not raise any new types of safety or effectiveness questions.

## Indications For Use

BTL-094 is indicated to be used for:

- Relief of minor muscle aches and pains.
- Temporary increase in local blood circulation.
- Activation of connective tissue.

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Image /page/5/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of a blue geometric design on the left and the text "BTL Industries" on the right. The geometric design is made up of three squares, each containing the letters "B", "T", and "L" respectively.

## Non-clinical Testing

The BTL-094 device has been thoroughly evaluated for electrical safety. The device has been found to comply with the following applicable medical device safety standards:

| IEC 60601-1:2005/A1:2012<br>FR Recognition Number: 19-4 | Medical electrical equipment - Part 1: General requirements for<br>basic safety and essential performance |
|-----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-2:2014<br>FR Recognition Number: 19-8 | Medical electrical equipment – Part 1-2: General requirements for<br>basic safety and essential performance - Collateral standard:<br>Electromagnetic disturbances - Requirements and tests |
| IEC 60601-1-6:2010/A1:2013<br>FR Recognition Number: 5-89 | Medical electrical equipment - Part 1-6: General requirements for<br>basic safety and essential performance - Collateral standard:<br>Usability |
| IEC 60601-2-36:2014<br>FR Recognition Number: 9-119 | Medical electrical equipment - Part 2-36: Particular requirements for<br>the basic safety and essential performance of equipment for<br>extracorporeally induced lithotripsy |
| IEC 62304:2006/A1:2015<br>FR Recognition Number: 13-79 | Medical device software – Software lifecycle processes |
| ISO 14971:2019<br>FR Recognition Number: 5-125 | Medical devices - Application of risk management to medical<br>devices |
| ISO 10993-1:2018<br>FR Recognition Number: 2-258 | Biological evaluation of medical devices – Part 1: Evaluation and<br>testing within a risk management process |
| ISO 10993-5:2009<br>FR Recognition Number: 2-245 | Biological evaluation of medical devices - Part 5: Tests for in vitro<br>cytotoxicity |
| ISO 10993-10:2010<br>FR Recognition Number: 2-174 | Biological evaluation of medical devices – Part 10: Tests for<br>irritation and skin sensitization |

## Clinical Testing

Not aplicable

## Technological Characteristics

The BTL-094 is a non-invasive therapeutic device, which uses acoustic waves in order to stimulate a local biological response in the treated tissue.

The BTL-094 generates extracorporeally induced massage pulses to stimulate a local biological response in the treated tissue. The main source of acoustic waves is a piezo transducer inside the applicator. The energy transfer from the piezo transducer to the treated tissue is realized via coupling pad.

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The mechanism of action and technological similarities and differences between the BTL-094 device and the predicate devices are described below in the comparison table. The differences do not raise any new types of safety or effectiveness questions.

| Comparison with the Predicate Device | | | |
|--------------------------------------|--|--|--|
|--------------------------------------|--|--|--|

| 510(k)<br>number | K221865 | K173692 | K220538 | |
|-----------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | BTL-094 | D-Actor 200 | DolorClast®<br>Radial | |
| Company<br>name | BTL Industries Inc. | Storz Medical | EMS Electro<br>Medical SA | |
| Indications for<br>Use | Relief of minor<br>muscle aches and<br>pains<br>Temporary increase<br>in local blood<br>circulation<br>Activation of<br>connective tissue | *Relief of minor<br>muscle aches and<br>pains<br>*Temporary increase<br>in local blood<br>circulation<br>*Activation of<br>connective tissue | - Relief of minor<br>muscle aches and<br>pains.<br>- Temporary<br>increase in local<br>blood circulation.<br>- Activation of<br>connective tissue. | None |
| Product Code<br>and<br>Regulation | 21 CFR<br>890.5660<br>ISA | 21 CFR<br>890.5660<br>ISA | 21 CFR<br>890.5660<br>ISA | None |
| Modes of<br>Action | Extracorporeally<br>induced pressure<br>waves. | Radial pressure<br>waves, or<br>extracorporeal pulse<br>activation<br>respectively | Radial pressure<br>waves, or<br>extracorporeal<br>pulse activation<br>respectively | Not Significantly<br>different<br>Please see the<br>discussion and<br>conclusion below. |
| Mechanisms of<br>Action | Vibrations generated<br>by electroacoustic<br>technology. | Pneumatically<br>generated vibrations | Pneumatically<br>generated<br>vibrations | Not Significantly<br>different<br>Please see the<br>discussion and<br>conclusion below. |
| Maximum and<br>Minimum<br>intensity<br>settings | 5-30%<br>alternative output<br>power setting scale | 1-5bar | 1-4bar | Not Significantly<br>different<br>Differences are<br>caused by<br>alternative<br>technology of the<br>pressure wave<br>generation. |
| Number and<br>size of<br>treatment<br>applicator<br>heads | 2;<br>L Pad - 12.2 cm²<br>U Pad - 7.3 cm² | 4;<br>6mmOD, 15mmOD,<br>20mmOD, 35mmOD | 7;<br>5mm OD, 10 mm<br>OD, 15 mm OD, 25<br>mm OD, 40 mm OD | Not Significantly<br>different<br>The application<br>area of the pads in<br>contact with the<br>patient is within the<br>set range of the<br>predicate devices.<br>All materials in<br>contact with the<br>patient have been<br>assessed for<br>biocompatibility |
| Maximum and<br>minimum<br>displacements<br>of applicator<br>heads | N/A | 0.6 - 2.0mm | 0.18 - 0.28 mm | N/A<br>The BTL-094<br>applicator does not<br>have any moving<br>parts that come in<br>contact with the<br>patient. |
| Type of<br>application<br>(e.g.,<br>continuous<br>vibration at a<br>fixed<br>frequency); | Continuous vibration<br>at a fixed frequency<br>and single pulse<br>mode | Continuous vibration<br>at a fixed frequency | Continuous<br>vibration at a fixed<br>frequency | None |
| Maximum and<br>minimum<br>vibration<br>frequency | 1-25 Hz | 1-21Hz | 1-25 Hz | Not Significantly<br>different |
| Power Supply | 100 V to 240 V AC<br>50 - 60 Hz<br>150VA | 500VA | Mains power | None |
| Maximum<br>penetration<br>depth | 35 mm | 32.3mm | 40 mm | Not Significantly<br>different<br>Please see the<br>discussion and<br>conclusion below. |
| Energy flow<br>density | In the range of<br>0.01 - 0.11 mJ/mm2 | Values of ultrasonic<br>pulse:<br>5bar/0.284mJ/mm2<br>3bar/0.176mJ/mm2 | 0.29 mJ/mm2 at 4<br>bar<br>0.14 mJ/mm2 at 2.4<br>bar | Not Significantly<br>different |
| Operating<br>mode | Continuous | Continuous | Continuous | None |
| Projectile<br>mass (g) | N/A | 3 | 3.2 | Not applicable<br>The BTL-094<br>applicator does not<br>contain a projectile. |
| Pulse repeat<br>rate (1/s) | 1-25 Hz | 1-21Hz | 1-25 Hz | Not Significantly<br>different |
| Number of<br>pulses (min<br>and max) | Variable in range<br>0 – 9999 | Variable | Variable,<br>Max<br>5000/treatment | Not Significantly<br>different |
| Maximum<br>operating<br>temperature | 10 - 35 °C | 10-40°C | 10 - 30 °C | Not Significantly<br>different |
| Type of<br>acoustic wave<br>generation | Electroacoustic<br>technology with<br>electroacoustic lens<br>system | Pneumatic/ballistic | Pneumatic/ballistic | Not Significantly<br>different<br>Differences are<br>caused by<br>alternative<br>technology of the<br>pressure wave<br>generation. |
| Positive peak<br>pressure<br>amplitude<br>(MPa) | In the range of<br>3 - 10 MPa | Values of ultrasonic<br>pulse: 5bar/18.5MPa<br>3bar/13.4MPa | 17 MPa at 4 bar<br>11.24 MPa at 2.4<br>bar | Not Significantly<br>different<br>Please see the<br>discussion and<br>conclusion below. |
| Negative peak<br>pressure<br>amplitude<br>(MPa) | In the range of<br>3 - 10 MPa | Values of ultrasonic<br>pulse: 5bar/6.8MPa<br>3bar/5.0MPa | 10 MPa at 4 bar<br>7.2 MPa at 2.4 bar | Not Significantly<br>different<br>Please see the<br>discussion and<br>conclusion below. |
| Derived focal<br>acoustic pulse<br>energy (mJ) | In the range of<br>0.1 – 1.4 mJ | Values of ultrasonic<br>pulse: 5bar/6.5mJ<br>3bar/2.4mJ | 5.9 mJ at 4 bar*<br>2.2 mJ at 2.4 bar*<br>*Averaged across<br>all applicator sizes. | Not Significantly<br>different<br>Please see the<br>discussion and<br>conclusion below. |
| Derived<br>pulse-<br>intensity<br>integral,<br>integrated over<br>total temporal<br>integration<br>limits<br>(mJ/mm2) | In the range of<br>0.01 - 0.11 mJ/mm2 | Values of ultrasonic<br>pulse:<br>5bar/0.284mJ/mm2<br>3bar/0.176mJ/mm2 | 0.29 mJ/mm2 at 4<br>bar<br>0.14 mJ/mm2 at 2.4<br>bar | Not Significantly<br>different<br>Please see the<br>discussion and<br>conclusion below. |
| Rise time (ns) | 10 ns | Ultrasonic pulse:<br>2.5µs | 3.2 µs | Not Significantly<br>different |
| | | Sonic pulse: 25µs –<br>2.5ms | | Differences are<br>caused by<br>alternative<br>technology of the<br>energy generation. |
| Compressional<br>pulse duration<br>(μs) | 2µs | Ultrasonic pulse:<br>5.0µs Sonic pulse:<br>50µs – 5.0ms | 2.6 µs (1st peak)<br>62.7 µs (1st phase) | Not Significantly<br>different |

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Image /page/7/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three interconnected blue squares with the letters "BTL" inside. To the right of the logo, the words "BTL Industries" are written in a modern, sans-serif font. The text is in a dark gray color.

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Image /page/8/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three nested squares with the letters "BTL" inside the innermost square. To the right of the logo is the text "BTL Industries" in a sans-serif font.

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Image /page/9/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three blue squares nested inside each other, with the letters "BTL" in white inside the innermost square. To the right of the square logo is the text "BTL Industries" in a gray sans-serif font.

#### Modes of Action, Mechanisms of Action

The technology used in BTL-094 device differs from the predicate device. Nevertheless, the technology creates the same type of acoustic pressure delivered to the tissue. Similar devices that generate a pressure wave based on a different technological principle but with the same or very comparable mechanism of action have already been recognised as substantially equivalent in this device category.

#### Maximum and Minimum intensity settings

BTL-094 has an alternative type of technology from the predicate device and therefore the BTL-094 device has an alternative power setting scale - in percentage and not in bars as a comparative device has. In addition, for comparability with the predicate devices the BTL-094 device intended for the US market is limited to a maximum power level of 30% of maximum driving power.

#### Number and size of treatment applicator heads

The number of application pads are different from predicate device but the area of the subjected device pads that is in contact with the patient is comparable within a set range to the contact area of application tips of predicate devices. Additionally all materials in contact with patient have been assessed for biocompatibility and the maximal depth of pressure wave penetration is comparable to the predicate.

#### Maximum and minimum displacements of applicator heads

The predicate device is generating the pressure wave by the head displacement. Due to an alternative type of technology used for pressure wave generation the BTL-094 device does not have the ability of displacements of applicator heads/pads.

#### Maximum and minimum vibration frequency

BTL-094 device differs from one predicate device in the value of the maximum frequency, where the frequency value of the BTL-094 device can be up to 4Hz higher than the predicate device, but has available the same frequency range as its second predicate device.

#### Driving Power

BTL-094 device has an alternative type of technology from the predicate device and therefore the driving power parameter is not applicable. In addition, for comparability with the predicate devices the BTL-094 device intended for the US market is limited to a maximum power level of 30% of maximum driving power.

#### Energy flow density

BTL-094 device uses alternative technology and is able to better pulse targeting, a maximum driving power of the device has been limited at a maximum power level of 30%. The EFD of our device differs from the predicates but it is lower or within setting range of predicat devices.

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Image /page/10/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of a geometric design on the left and the text "BTL Industries" on the right. The geometric design is made up of three squares, each rotated 45 degrees and nested inside the other. The text "BTL Industries" is written in a sans-serif font.

#### Operating mode

The BTL-094 device has two modes of operation: single therapy mode or sequence mode. The two modes differ based on repetition of therapy sections and settings that can be done during the running therapy. Nevertheless, both the modes have a character of continual therapy.

#### Maximum penetration depth

The BTL-094 device is equipped with two different coupling pad sizes, which allow it to reach up to 35 mm depth. This penetration depth is comparable within setting range of predicate devices.

#### Pulse repeat rate (1/s)

BTL-094 device differs from one predicate device in the value of the maximum frequency, where the frequency value of the BTL-094 device can be up to 4Hz higher than the predicate device, but has available the same frequency range as its second predicate device.

#### Number of pulses (min and max)

BTL-094 device allows to set a variable number of pulses according to the user's needs. This parameter is similar as for the predicate device.

#### Type of acoustic wave generation

The subject device provides the therapy by the application of extracorporeally induced acoustic pressure waves that are generated by means of piezoelectric principle. The device is designed with planar piezoelement and acoustic lens quiding the waves. The generated wave is coupled to biological tissue via the coupling gel pads of the applicator.

This technology creates the same type of acoustic pressure wave with comparable parameters therefore it reach the same mechanism of action as the predicate devices.

#### Positive peak pressure amplitude (MPa)

A maximum driving power of the BTL-094 has been limited at a maximum power level of 30%. The device with this limitation in maximal output power fits with output parameters within or bellow setting range of predicat devices and is not significantly different from the predicate devices.

#### Negative peak pressure amplitude (MPa)

A maximum driving power of the BTL-094 has been limited at a maximum power level of 30%. The device with this limitation in maximal output power fits with output parameters within or bellow setting range of predicat devices and is not significantly different from the predicate devices.

#### Derived focal acoustic pulse energy (mJ)

A maximum driving power of the BTL-094 has been limited at a maximum power level of 30%. The device with this limitation in maximal output power fits with output parameters within or bellow setting range of predicat devices and is not significantly different from the predicate devices.

#### Derived pulse- intensity integrated over total temporal integration limits (m.J/mm2)

A maximum driving power of the BTL-094 has been limited at a maximum power level of 30%. The device with this limitation in maximal output power parameters within or bellow setting range of predicat devices and is not significantly different from the predicate devices.

#### Rise time (ns)

BTL-094 has an alternative type of technology from the predicate device and therefore the BTL-094 device is able to reach a faster rise time and shorter compressional pulse duration.

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Image /page/11/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three blue interlocking squares on the left, with the letters "BTL" inside the squares. To the right of the squares is the text "BTL Industries" in a gray sans-serif font. The logo is simple and modern, and the use of blue and gray gives it a professional look.

#### Compressional pulse duration (µs)

BTL-094 has an alternative type of technology from the predicate device and therefore the BTL-094 device is able to reach a faster rise time and shorter compressional pulse duration.

## Substantial Equivalence

The BTL-094 is substantially equivalent to the predicate devices D-Actor (K173692) and DolorClast® Radial (K220538). The subject device is safe and effective for its intended use.

Any differences between the predicate devices and BTL-094 have no significant influence on the safety or effectiveness of the subject device. Therefore, the BTL-094 is substantially equivalent to the predicate devices.

## Conclusion

Based upon the intended use and known technical information provided in this pre-market notification, the BTL-094 device has been shown to be substantially equivalent to the currently marketed predicate device.