(275 days)
ELECTROTHERAPY
VMS, VMS Burst, Russian, Monophasic Hi-Volt (NMES). Interferential and Premodulated (IFS) are indicated for relaxation of muscle spasms; prevention of disuse atrophy; increase of local blood circulation; muscle reeducation; maintaining or increasing range of motion and immediate postsurgical stimulation of calf muscles to prevent venous thrombosis.
Microcurrent, Interferential, Premodulated (IFS), VMS Burst, Asymmetrical Biphasic (TENS) and Symmetrical Biphasic (TENS) are indicated for symptomatic relief and management of chronic, intractable pain; post-traumatic acute pain and post-surgical acute pain.
FES is indicated for stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the foot and thus improve the patient's gait.
DC Continuous Mode is indicated for relaxation of muscle spasm.
ULTRASOUND THERAPY
Ultrasound module is indicated for an application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as: relief of pain, muscle spasms and joint contractures; relief of pain, muscle spasms and joint contractures that may be associated with: adhesive capsultis, with slight calcification, myositis, soft tissue injuries, shortened tendons due to past injuries and scar tissues; relief of sub-chronic pain and joint contractures resulting from: capsular tightness, capsular scaring.
LASER THERAPY
Laser module is indicated for topical heating for: temporary increase of local blood circulation; temporary relief of minor muscle and joint aches, pains, and stiffness; relaxation of muscles; temporary relief of muscle spasms and temporary relief of minor pain and stiffness associated with arthritis.
BTL-4000 is a professional physiotherapy device. Depending on the required configuration, the device can consist of up to three generators - electrotherapy, ultrasound therapy and laser therapy.
Electrotherapy is a non-invasive therapeutic method based on electrical current flow through the human tissues. The electric current is applied with the use of electrodes directly through the patient's skin. The use of electrotherapy is accepted in the field of rehabilitation. Ultrasound therapy is a non-invasive therapeutic method, which uses mechanical energy of the longitudinal waves penetrating deep through human soft-tissues. Mechanical waves are absorbed in the tissues and transformed into heat energy.Low-level laser therapy is a noninvasive therapeutic method based on the application of coherent, polarized, monochromatic light in the form of a laser beam. The laser beam is absorbed in the tissues.
BTL-4000 is equipped with a colour touch screen, which considerably simplifies its operation. Therapy is simply started by a quick selection from the list of the most frequently used therapeutic protocols or by selecting from the list of all therapeutic protocols. A sophisticated function of the device is the possibility to select the optimum therapy according to the required therapeutic effect or according to the place of application.
The BTL-4000 consists of the following main components:
- . control unit
- user interface with 7" LCD color touch screen ●
- therapy modules electrotherapy, ultrasound and laser .
- accessories depends on the combination - electrotherapy electrodes
- laser probe/cluster
- । ultrasound head/HandsFree sono handpiece
The provided text is a 510(k) premarket notification for the BTL-4000 device, which is an ultrasound and muscle stimulator. It explicitly states that the substantial equivalence determination for this device is NOT based on clinical performance testing. Instead, it relies on comparison of technical characteristics between the BTL-4000 and predicate devices.
Therefore, the document does not contain the information requested regarding acceptance criteria, device performance from a clinical study, sample sizes, ground truth establishment, expert adjudication, or MRMC studies.
The document states:
- "The substantial equivalence determination for the BTL-4000 is not based upon clinical performance testing. The device safety and efficacy was demonstrated by comparison of technical characteristics between the BTL-4000 and compared to the predicate device." (Page 7)
This means there is no study described that proves the device meets specific acceptance criteria in a clinical setting as would be the case for an AI/ML medical device. The "acceptance criteria" here implicitly refer to meeting the defined technical specifications that are comparable to previously cleared predicate devices.
However, to address the prompt as best as possible given the available text, I can infer the "acceptance criteria" are the technical specifications and indications for use, and the "proof" is the comparison table demonstrating similarity to predicate devices.
Here's how I can construct a response based on the inference that the "acceptance criteria" are the technical specifications and the "study" is the comparison to predicate devices, while clearly stating the limitations of the provided text:
The provided 510(k) premarket notification for the BTL-4000 device explicitly states that its substantial equivalence determination is not based on clinical performance testing. Instead, the device's safety and efficacy are demonstrated by a comparison of its technical characteristics to legally marketed predicate devices. Therefore, the document does not describe a conventional clinical study with acceptance criteria and performance data as might be found for novel AI/ML medical devices.
Despite this, we can interpret the technical specifications and indications for use as implicit "acceptance criteria" for substantial equivalence. The "study" that proves the device meets these criteria is the detailed "Comparison with the Predicate Device" table provided in the submission.
Here's a breakdown based on this interpretation, noting where information is explicitly not present in the document:
1. Table of Acceptance Criteria and Reported Device Performance
In this context, the "Acceptance Criteria" are the technical specifications and indications of the predicate devices which the BTL-4000 aims to be substantially equivalent to. The "Reported Device Performance" is the BTL-4000's own technical specifications. The extensive comparison table serves this purpose.
Table: Comparison of BTL-4000 with Predicate Devices (Selected Parameters)
| Feature/Parameter | Acceptance Criteria (Predicate Device K031077 & K040662) | Reported Device Performance (BTL-4000) |
|---|---|---|
| Intended Use/Indications | Electrotherapy: Relaxation of muscle spasms; prevention/retardation of disuse atrophy; increase of local blood circulation; muscle re-education; maintaining/increasing range of motion; immediate postsurgical stimulation of calf muscles to prevent venous thrombosis. Symptomatic relief and management of chronic, intractable, post-traumatic acute, and post-surgical acute pain (for specific modes). FES for leg/ankle muscle stimulation to improve gait. DC Continuous Mode for relaxation of muscle spasm. | Exactly matches predicate indications as described. (See full list on page 8) |
| Ultrasound: Therapeutic deep heat for sub-chronic/chronic medical conditions; relief of pain, muscle spasms, joint contractures (associated with specific conditions like adhesive capsulitis, bursitis, myositis, soft tissue injuries, shortened tendons, scar tissues); relief of sub-chronic/chronic pain and joint contractures from capsular tightness/scarring. | Exactly matches predicate indications as described. (See full list on page 8) | |
| Laser: Topical heating for temporary increase of local blood circulation; temporary relief of minor muscle/joint aches, pains, stiffness; relaxation of muscles; temporary relief of muscle spasms; temporary relief of minor pain/stiffness associated with arthritis. | Exactly matches predicate indications as described. (See full list on page 8) | |
| Electrical Protection | Predicate K031077: Class I, BF. Predicate K040662: Class I, B. | BTL-4000: Class II, BF (for Electrotherapy Module: BF; for Ultrasound Module: Class II, BF; for Laser Module: BF) – Note: BTL-4000 claims substantial equivalence despite slight difference in class by meeting "BF" which is generally more stringent than "B" and Class II means double insulation, reducing reliance on protective earth compared to Class I. |
| Power Voltage & Frequency | ~100 V to 240 V AC, 50-60 Hz | ~100 V to 240 V AC, 50-60 Hz |
| Electrotherapy Channels | 2; 4 | 2; 4 |
| Electrotherapy Output Intensity | 0-500 V, 0-200 mA | 0-500 V, 0-200 mA |
| TENS-Asymmetrical Biphasic Intensity (CC Mode) | 0-110 mA | 0-110 mA |
| TENS-Asymmetrical Biphasic Frequency Range | 0-250 Hz | 1–250 Hz |
| Ultrasound Intensity (Continuous Mode) | 0 – 2.5 W/cm² | 0.1 – 2 W/cm² (±30%) – Note: Within comparable range, slight difference in upper limit but also has different modes. |
| Ultrasound Frequency | 1 MHz (±5%), 3.3 MHz (±5%) | 1 MHz (±5%), 3.1 MHz (±5%) – Note: Very slight difference in 3 MHz range, claimed to be equivalent. |
| Laser Wavelength | 670 - 950 nm | 685 - 830 nm (±20%) – Note: BTL-4000's range is within the broader predicate range, supporting equivalence for stated indications. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. No clinical test set data is provided. The "proof" is based on technical specifications comparison, not experimental data from a specific number of cases.
- Data Provenance: Not applicable. No clinical data is referenced. The technical specifications of the BTL-4000 are presumably derived from internal engineering and testing, and the predicate device data is from their original 510(k) submissions.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This information is not provided and is not relevant to this type of 510(k) submission which relies on technical comparison rather than clinical performance data requiring ground truth establishment.
4. Adjudication Method for the Test Set
- Not applicable. There was no clinical test set requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a MRMC study was not done. The document explicitly states: "The substantial equivalence determination for the BTL-4000 is not based upon clinical performance testing." This type of study would be part of clinical performance testing.
- Effect Size: Not applicable as no such study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a physical therapy machine, not a software algorithm. Its "performance" is its ability to deliver the specified electrical, ultrasound, or laser therapy, which is verified through conformity to safety and performance standards (Non-clinical Testing section).
7. The Type of Ground Truth Used
- Not applicable in the clinical sense. For the technical comparison, the "ground truth" for the predicate devices' performance are the parameters laid out in their cleared 510(k) submissions and compliance with relevant medical device safety standards (e.g., IEC 60601 series, ISO 14971, ISO 10993).
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML device; therefore, no training set was used.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for an AI/ML model, there is no ground truth to establish for it.
In summary, the BTL-4000 510(k) submission relies entirely on a demonstration of substantial equivalence through technical and functional comparisons to previously cleared predicate devices, rather than new clinical performance data. Therefore, the detailed questions about clinical study design, sample sizes, ground truth, and expert adjudication are not applicable to the evidence presented in this document.
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Image /page/0/Picture/11 description: The image contains the logo for the Department of Health & Human Services - USA. The logo features the department's emblem, which includes a stylized depiction of a human face in profile, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the emblem. The emblem is positioned to the right of the text.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 13, 2015
BTL Industries, Inc. Attn: Mr. Jan Zarsky Executive Vice President 47 Loring Drive Framingham, MA 01702
Re: K150353 Trade Name: BTL-4000 Regulation Number: 21 CFR 890.5860 Regulation Name: Ultrasound and muscle stimulator Regulatory Class: Class II Product Code: IMG, IPF, GZJ, GZI, LIH, ILY Dated: October 12, 2015 Received: October 14, 2015
Dear Mr. Zarsky:
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. 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 27f 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena-S
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150353
Device Name BTL-4000
Indications for Use (Describe) ELECTROTHERAPY
VMS, VMS Burst, Russian, Monophasic Hi-Volt (NMES). Interferential and Premodulated (IFS) are indicated for relaxation of muscle spasms; prevention of disuse atrophy; increase of local blood circulation; muscle reeducation; maintaining or increasing range of motion and immediate postsurgical stimulation of calf muscles to prevent venous thrombosis.
Microcurrent, Interferential, Premodulated (IFS), VMS Burst, Asymmetrical Biphasic (TENS) and Symmetrical Biphasic (TENS) are indicated for symptomatic relief and management of chronic, intractable pain; post-traumatic acute pain and post-surgical acute pain.
FES is indicated for stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the foot and thus improve the patient's gait.
DC Continuous Mode is indicated for relaxation of muscle spasm.
ULTRASOUND THERAPY
Ultrasound module is indicated for an application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as: relief of pain, muscle spasms and joint contractures; relief of pain, muscle spasms and joint contractures that may be associated with: adhesive capsultis, with slight calcification, myositis, soft tissue injuries, shortened tendons due to past injuries and scar tissues; relief of sub-chronic pain and joint contractures resulting from: capsular tightness, capsular scaring.
LASER THERAPY
Laser module is indicated for topical heating for: temporary increase of local blood circulation; temporary relief of minor muscle and joint aches, pains, and stiffness; relaxation of muscles; temporary relief of muscle spasms and temporary relief of minor pain and stiffness associated with arthritis.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/4/Picture/0 description: The image shows a logo for BTL, which is a telecommunications company in Belize. The logo consists of three blue diamonds that are interlocked. The letters "BTL" are written in white inside the diamonds. The logo is simple and modern, and it is easily recognizable.
Section 5 - 510(k) Summary
General Information
| Sponsor: | BTL Industries, Inc.47 Loring DriveFramingham, MA 01702Tel: +1-866-285-1656Fax: +1-888-499-2502 |
|---|---|
| Applicant: | BTL Industries, Inc.47 Loring DriveFramingham, MA 01702Tel: +1-866-285-1656Fax: +1-888-499-2502 |
- Contact Person: Jan Zarsky BTL Industries, Inc. Executive VP zarsky@btlnet.com
Summary Preparation 5 February, 2015 Date:
Device Names
Trade/Proprietary Name: BTL-4000
Classification Name:
21 CFR 890.5300 Ultrasonic diathermy 21 CFR 890.5500 Infrared lamp 21 CFR 890.5850 Powered muscle stimulator 21 CFR 890.5860 Ultrasound and Muscle stimulator 21 CFR 882.5890 TENS for pain relief 21 CFR 882.5810 External functional neuromuscular stimulator
Product Code:
GZI - Stimulator, Neuromuscular, External Functional GZJ - Stimulator, Nerve, Transcutaneous, for Pain Relief ILY - Lamp, Infrared, Therapeutic Heating IMG - Stimulator, Ultrasound and Muscle, for Use in Applying Therapeutic Deep Heat IPF - Stimulator, Muscle, Powered LIH - Interferential Current Therapy
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Image /page/5/Picture/0 description: The image shows a logo with three interconnected blue squares. Each square has a letter inside: 'B', 'T', and 'L' respectively. The squares are arranged horizontally and slightly overlap, creating a linked chain effect. The logo appears to be for an organization or company with the initials BTL.
Legally Marketed Predicate Devices
BTL-4000 is substantially equivalent to the current products that are already cleared for USA distribution under the following 510(k) Premarket Notification numbers:
- Vectra Genisys Chattanooga Medical Supply, Inc. (K031077) .
- . Vectra Genisys Laser Module - Chattanooga Medical Supply, Inc. (K040662)
Product Description
BTL-4000 is a professional physiotherapy device. Depending on the required configuration, the device can consist of up to three generators - electrotherapy, ultrasound therapy and laser therapy.
Electrotherapy is a non-invasive therapeutic method based on electrical current flow through the human tissues. The electric current is applied with the use of electrodes directly through the patient's skin. The use of electrotherapy is accepted in the field of rehabilitation. Ultrasound therapy is a non-invasive therapeutic method, which uses mechanical energy of the longitudinal waves penetrating deep through human soft-tissues. Mechanical waves are absorbed in the tissues and transformed into heat energy.Low-level laser therapy is a noninvasive therapeutic method based on the application of coherent, polarized, monochromatic light in the form of a laser beam. The laser beam is absorbed in the tissues.
BTL-4000 is equipped with a colour touch screen, which considerably simplifies its operation. Therapy is simply started by a quick selection from the list of the most frequently used therapeutic protocols or by selecting from the list of all therapeutic protocols. A sophisticated function of the device is the possibility to select the optimum therapy according to the required therapeutic effect or according to the place of application.
The BTL-4000 consists of the following main components:
- . control unit
- user interface with 7" LCD color touch screen ●
- therapy modules electrotherapy, ultrasound and laser .
- accessories depends on the combination - electrotherapy electrodes
- laser probe/cluster
- । ultrasound head/HandsFree sono handpiece
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Image /page/6/Picture/0 description: The image shows a logo with three blue diamond shapes connected together. Inside the diamonds are the letters "BTL". Below the logo is the text "Indications for Use" in a bold, sans-serif font. The text is black and centered below the logo.
For Electrotherapy
For VMS, VMS Burst, Russian, Monophasic Hi-Volt (NMES), Interferential and Premodulated (IFS):
- relaxation of muscle spasms -
- prevention or retardation of disuse atrophy -
- increase of local blood circulation -
- muscle re-education
- maintaining or increasing range of motion -
- immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
Additionally for Microcurrent, Interferential, Premodulated (IFS), VMS, VMS Burst, Asymmetrical Biphasic (TENS) and Symmetrical Biphasic (TENS):
- symptomatic relief and management of chronic, intractable pain -
- post-traumatic acute pain
- post-surgical acute pain
For FES:
Stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the foot and thus improve the patient's gait.
For DC Continunous Mode:
- relaxation of muscle spasm -
For Ultrasound:
Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as:
- relief of pain, muscle spasms and joint contractures ।
- relief of pain, muscle spasms and joint contractures that may be associated with:
- adhesive capsulitis
- bursitis with slight calcification
- I myositis
- soft tissue injuries
- shortened tendons due to past injuries and scar tissues
relief of sub-chronic, chronic pain and joint contractures resulting from:
- capsular tightness .
- capsular scarring .
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Image /page/7/Picture/0 description: The image shows a logo with the letters BTL inside of three squares. Below the logo is the text "For Laser:", followed by the text "Is indicated for topical heating for:". The text is in black font and is left-aligned.
- temporary increase of local blood circulation
- temporary relief of minor muscle and joint aches, pains, and stiffness -
- relaxation of muscles
- temporary relief of muscle spasms -
- temporary relief of minor pain and stiffness associated with arthritis -
Non-clinical Testing
The BTL-4000 device has been thoroughly evaluated for electrical safety. The BTL-4000 has been found to conform with applicable medical device safety standards. The system complies with the following standards:
ISO 14971 - Medical devices - Application of risk management to medical devices IEC 62304 - Medical Device Software - Software Life Cycle Processes
Medical Electrical Equipment
- General requirements for safety IEC 60601-1
- IEC 60601-1-2 Electromagnetic compatibility-Requirements and Tests
- IEC 60601-2-5 Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
- IEC 60601-2-10 Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
- IEC 60601-2-22 Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- IEC 60825-1 Safety of laser products - Part 1: Equipment classification and requirements
- IEC 60601-1-6 General requirements for basic safety and essential performance -Collateral standard: Usability
- Evaluation and testing within a risk management process ISO 10993-1
- ISO 10993-5 Biological Evaluation of Medical Devices-Tests for In Vitro toxicity
- ISO 10993-10 Biological Evaluation of Medical Devices-Test for Irritation and Skin Sensitization
- ISO 14971 Medical devices Application of risk management to medical devices IEC 62304 - Medical Device Software - Software Life Cycle Processes
Clinical testing
The substantial equivalence determination for the BTL-4000 is not based upon clinical performance testing. The device safety and efficacy was demonstrated by comparison of technical characteristics between the BTL-4000 and compared to the predicate device.
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Image /page/8/Picture/0 description: The image shows a logo with three interconnected blue diamonds. Inside each diamond is a letter, spelling out "BTL". The letters are also in blue, matching the color of the diamonds. The logo has a clean and modern design.
Comparison with the Predicate Device
| Device Name | BTL-4000 | Vectra Genisys | Vectra Genisys LaserSystem |
|---|---|---|---|
| Manufacturer | BTL Industries, Inc. | Chattanooga Medical Supply, Inc. | Chattanooga MedicalSupply, Inc. |
| 510(k) Number | Current submission | K031077 | K040662 |
| Intended Use | For VMS, VMS Burst, Russian,Monophasic Hi-Volt (NMES), Interferentialand Premodulated (IFS):- relaxation of muscle spasms- prevention or retardation of disuseatrophy- increase of local blood circulation- muscle re-education- maintaining or increasing range ofmotion- immediate postsurgical stimulation ofcalf muscles to prevent venousthrombosisAdditionally for Microcurrent,Interferential, Premodulated (IFS), VMS,VMS Burst, Asymmetrical Biphasic(TENS) and Symmetrical Biphasic(TENS):- symptomatic relief and management ofchronic, intractable pain- post-traumatic acute pain- post-surgical acute painFor FES:Stimulation of the muscles in the leg andankle of partially paralyzed patients toprovide flexion of the foot and thusimprove the patient's gait.For DC Continuous Mode:- Relaxation of muscle spasmFor Laser:the laser module is indicated for topicalheating for:-temporary increase in local bloodcirculation-temporary relief of minor muscle andjoint aches, pains, and stiffness-relaxation of muscles-temporary relief of muscle spasms-temporary relief of minor pain andstiffness associated with arthritisFor UltrasoundApplication of therapeutic deep heat forthe treatment of selected sub-chronic andchronic medical conditions such as:- relief of pain, muscle spasms and jointcontractures- relief of pain, muscle spasms and jointcontractures that may be associated with:-adhesive capsulitis-bursitis with slight calcification-myositis-soft tissue injuries-shortened tendons due to past injuriesand scar tissues-relief of sub-chronic, chronic pain andjoint contractures resulting from:-capsular tightness-capsular scarring | For VMS, VMS Burst, Russian,Monophasic Hi-Volt (NMES), Interferentialand Premodulated (IFS):- relaxation of muscle spasms- prevention or retardation of disuse atrophy- increase of local blood circulation- muscle re-education-maintaining or increasing range of motion- immediate postsurgical stimulation of calfmuscles to prevent venous thrombosisAdditionally for Microcurrent, Interferential,Premodulated (IFS), VMS, VMS Burst,Asymmetrical Biphasic (TENS) andSymmetrical Biphasic (TENS):- symptomatic relief and management ofchronic, intractable pain- post-traumatic acute pain- post-surgical acute painFor FES:Stimulation of the muscles in the leg andankle of partially paralyzed patients toprovide flexion of the foot and thus improvethe patient's gait.For DC Continuous Mode:- Relaxation of muscle spasmFor EMG:To determination the activation timing ofmuscles for a) retraining of muscleactivation b) coordination of muscleactivation An indication of the forceproduced by muscle for control andmaintenance of muscle contractions.Relaxation muscle training. Muscle re-educationFor EMG triggered Stim:Stroke rehab by muscle re-education-Relaxation of muscle spasm-Prevention of retardation of disuse atrophy-Increase local blood circulation-Muscle re-education-Maintaining or increase range of motionFor Ultrasound:Application of therapeutic deep heat for thetreatment of selected sub-chronic andchronic medical conditions such as:-relief of pain, muscle spasms and jointcontractures-relief of pain, muscle spasms and jointcontractures that may be associated with:-adhesive capsulitis-bursitis with slight calcification-myositis-soft tissue injuries-shortened tendons due to past injuriesand scar tissues-relief of sub-chronic, chronic pain andjoint contractures resulting from:-capsular tightness-capsular scarring | Vectra Genisys (Intelect XT)Laser Module and VectraGenisys (InteleXT) Laser TransportableSystems are indicated fortopical heating for:-temporary increase in localblood circulation-temporary relief of minormuscle and joint aches,pains, and stiffness-relaxation of muscles-temporary relief of musclespasms-temporary relief of minorpain and stiffnessassociated with arthritis |
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Image /page/9/Picture/0 description: The image shows a blue logo with the letters BTL inside of three diamond shapes. The diamond shapes are connected to each other. The logo is simple and modern. The color blue is a calming and professional color.
| Device Name | BTL-4000 | Vectra Genisys | Vectra Genisys LaserSystem |
|---|---|---|---|
| Manufacturer | BTL Industries, Inc. | Chattanooga Medical Supply, Inc. | Chattanooga MedicalSupply, Inc. |
| 510(k) Number | Current submission | K031077 | K040662 |
| Product Code | GZIGZJILYIMGIPFLIH | GZIGZJIMGIPFнссLIH | ILY |
| ElectricalProtection | Class II, BF | Class I, BF | Class I, B |
| Dimensions | 380×190×260 mm | 289×222×324 mm | 288mm(with applicator) /239mm(withoutapplicator)×163mm×328mm |
| Power Voltage andFrequency | ~ 100 V to 240 V AC, 50-60 Hz | ~ 100 V to 240 V AC, 50-60 Hz | ~ 100 V to 240 V AC, 50-60 Hz |
| Covering Grade | IP20 | IPX0 | unknown |
| Display | colour, touchscreen | colour, display | |
| Trolley available | yes | yes | yes |
| Body areasIndication | yes | yes | yes |
| Battery module | optional | optional | yes |
| OperatingConditions | 10 °C to +30 °C30 % to 75 %700 hPa to 1,060 hPa | 100-240 V - 1.0 A, 50/60 Hz | 10 °C to +30 °C30 % to 75 %700 hPa to 1,060 hPa |
| Electrotherapy Module | |||
| Electricalprotection | BF | BF | N/A |
| Number ofchannels | 2; 4 | 2; 4 | N/A |
| Output Intensity | 0-500 V, 0-200 mA | 0-500 V, 0-200 mA | N/A |
| ElectrotherapyCurrents | IFC - Interferential (Traditional 4 Pole)Premodulated (Traditional 2 Pole IFC)TENS - Symmetrical BiphasicTENS - Asymmetrical BiphasicRussianDirect CurrentMicrocurrentHigh Voltage Pulsed Current (HVPC)VMS. VMS Burst | IFC - Interferential (Traditional 4 Pole)Premodulated (Traditional 2 Pole IFC)TENS - Symmetrical BiphasicTENS - Asymmetrical BiphasicRussianDirect CurrentMicrocurrentHigh Voltage Pulsed Current (HVPC)VMS. VMS Burst | N/A |
| EMG(Biofeedback) | no | yes | N/A |
| TENS - asymmetrical biphasic | |||
| Intensity - CCMode | 0-110 mA | 0–110 mA | N/A |
| Intensity - CVmode | 0-110 V | 0-110 V | N/A |
| Maximum PhaseDuration | 20-1000 us | 20-1000 us | N/A |
| Frequency Range | 1–250 Hz | 0–250 Hz | N/A |
| Device Name | BTL-4000 | Vectra Genisys | Vectra Genisys LaserSystem |
| Manufacturer | BTL Industries, Inc. | Chattanooga Medical Supply, Inc. | Chattanooga MedicalSupply, Inc. |
| 510(k) Number | Current submission | K031077 | K040662 |
| Maximum AveragePower Density | Electrode 7.5×14 cm -> 0.05 W/cm2Electrode 3.2 cm -> 0.62 W/cm-Electrode 5 cm -> 0.25 W/cm2 | N/A | |
| Current Density | Depends on the surface of the chosenelectrode 0.1-14 mA/cm- | Depends on the surface of the chosenelectrode 0.1-16 mA/cm- | N/A |
| Waveform Shape | N/A | ||
| Electrode Size | 7.5×14 cm3.2 cm5 cm | 3 cm7 cm | N/A |
| Number ofChannels | 2 | 2 | N/A |
| Channel Isolation | 1 MOPP (1500 V) | - | N/A |
| TENS - symmetrical biphasic | |||
| Intensity - CCMode | 0-80 mA | 0-80 mA | N/A |
| Intensity - CVmode | 0-80 V | 0–80 V | N/A |
| Maximum PhaseDuration | 20-1000 us | 20-1000 us | N/A |
| Frequency Range | 1–250 Hz | 1–250 Hz | N/A |
| Maximum AveragePower Density | Electrode 7.5×14 cm -> 0.05 W/cm2Electrode 3.2 cm -> 0.62 W/cm2Electrode 5 cm -> 0.25 W/cm2 | N/A | |
| Current Density | Depends on the surface of the chosenelectrode 0.1-10 mA/cm- | Depends on the surface of the chosenelectrode 0.1-11.5 mA/cm- | N/A |
| Waveform Shape | N/A | ||
| Electrode Size | 7.5×14 cm3.2 cm5 cm | 3 cm7 cm | N/A |
| Number ofChannels | 2 | 2 | N/A |
| Channel Isolation | 1 MOPP (1500 V) | - | N/A |
| IFC - Interferential | |||
| Intensity - CCMode | 0-100 mA | 0-100 mA | N/A |
| Intensity - CVmode | 0-100 V | 0-100 V | N/A |
| Maximum PhaseDuration | N/A | ||
| Frequency Range | Carrier->2500, 4000 and 5000 HzBeat (sweep off)->1-200 HzSweep Low Beat Frequency->1-199 HzSweep High Beat Frequency->1-200Hz | Carrier->2500, 4000 and 5000 HzBeat (sweep off)->1-200 HzSweep Low Beat Frequency->1-199 HzSweep High Beat Frequency->1-200 Hz | N/A |
| Maximum AveragePower Density | Electrode 7.5×14 cm→0.05 W/cm²Electrode 3.2 cm->0.62 W/cm-Electrode 5 cm->0.25 W/cm2 | N/A | |
| Current Density | Depends on the surface of the chosenelectrode 0.1-12.5 mA/cm- | Depends on the surface of the chosenelectrode 0.1-14 mA/cm- | N/A |
| Waveform Shape | N/A | ||
| Electrode Size | 7.5×14 cm3.2 cm5 cm | 3 cm7 cm | N/A |
| Number ofChannels | 2 | 2 | N/A |
| Channel Isolation | 1 MOPP (1500 V) | - | N/A |
| Device Name | BTL-4000 | Vectra Genisys | Vectra Genisys LaserSystem |
| Manufacturer | BTL Industries, Inc. | Chattanooga Medical Supply, Inc. | Chattanooga MedicalSupply, Inc. |
| 510(k) Number | Current submission | K031077 | K040662 |
| Premodulated (2-pole Interference) | |||
| Intensity - CCMode | 0-100 mA | 0-100 mA | N/A |
| Intensity - CVmode | 0–100 V | 0-100 V | N/A |
| Maximum PhaseDuration | - | - | N/A |
| Frequency Range | Carrier→2500 HzBeat (sweep off)→1-200 HzSweep Low Beat Frequency→1-199HzSweep High Beat Frequency→2-200Hz | Carrier→2500 HzBeat (sweep off)→1-200 HzSweep Low Beat Frequency→1-199HzSweep High Beat Frequency→2-200Hz | N/A |
| Maximum AveragePower Density | Electrode 7.5×14 cm→0.05 W/cm²Electrode 3.2 cm→0.62 W/cm²Electrode 5 cm→0.25 W/cm² | - | N/A |
| Current Density | 0.1-12.5 mA/cm² | 0.1-14 mA/cm² | N/A |
| Waveform Shape | Image: [waveform] | Image: [waveform] | N/A |
| Electrode Size | 7.5×14 cm3.2 cm5 cm | 3 cm7 cm | N/A |
| Number ofChannels | 2 | 2 | N/A |
| Channel Isolation | 1 MOPP (1500 V) | - | N/A |
| Russian Stimulation | |||
| Intensity - CCMode | 0-100 mA | 0-100 mA | N/A |
| Intensity - CVmode | 0–100 V | 0–100 V | N/A |
| Maximum PhaseDuration | - | - | N/A |
| Frequency Range | Carrier→2500 HzBurst frequency→20-100 bps | Carrier→2500 HzBurst frequency→20-100 bps | N/A |
| Maximum AveragePower Density | Electrode 7.5×14 cm→0.05 W/cm²Electrode 3.2 cm→0.62 W/cm²Electrode 5 cm→0.25 W/cm² | - | N/A |
| Current Density | 0.1-12.5 mA/cm² | 0.1-14 mA/cm² | N/A |
| Waveform Shape | Image: [waveform] | Image: [waveform] | N/A |
| Electrode Size | 7.5×14 cm3.2 cm5 cm | 3 cm7 cm | N/A |
| Number ofChannels | 2 | 2 | N/A |
| Channel Isolation | 1 MOPP (1500 V) | - | N/A |
| Direct Current | |||
| Intensity - CCMode | 0–4 mA | 0-4 mA | N/A |
| Intensity - CVmode | - | - | N/A |
| Maximum PhaseDuration | - | - | N/A |
| Frequency Range | - | - | N/A |
| Maximum AveragePower Density | Electrode 7.5×14 cm→0.05 W/cm²Electrode 3.2 cm→0.62 W/cm²Electrode 5 cm→0.25 W/cm² | - | N/A |
| Device Name | BTL-4000 | Vectra Genisys | Vectra Genisys LaserSystem |
| Manufacturer | BTL Industries, Inc. | Chattanooga Medical Supply, Inc. | Chattanooga MedicalSupply, Inc. |
| 510(k) Number | Current submission | K031077 | K040662 |
| Waveform Shape | N/A | ||
| Electrode Size | 7.5×14 cm3.2 cm5 cm | 3 cm7 cm | N/A |
| Number ofChannels | 2 | 2 | N/A |
| Channel Isolation | 1 MOPP (1500 V) | - | N/A |
| Microcurrents | |||
| Intensity - CCMode | 5-1000 µA | 5-1000 µA | N/A |
| Intensity - CVmode | N/A | ||
| Maximum PhaseDuration | 0-1 s | N/A | |
| Frequency Range | Carrier->0.1-1000 Hz | Carrier->0.1-1000 Hz | N/A |
| Maximum AveragePower Density | Electrode 7.5×14 cm->0.05 W/cm2Electrode 3.2 cm->0.62 W/cm2Electrode 5 cm->0.25 W/cm2 | - | N/A |
| Current Density | 0-0.12 mA/cm- | 0-0.14 mA/cm² | N/A |
| Waveform Shape | N/A | ||
| Electrode Size | 7.5×14 cm3.2 cm5 cm | 3 cm7 cm | N/A |
| Number ofChannels | 2 | 2 | N/A |
| Channel Isolation | 1 MOPP (1500 V) | - | N/A |
| High Voltage Pulsed Current (HVPC) | |||
| Intensity - CCMode | N/A | ||
| Intensity - CVmode | 0-500 V | 0–200 V | N/A |
| Maximum PhaseDuration | 50 hs | N/A | |
| Frequency Range | 10-120 pps | 10-120 pps | N/A |
| Maximum AveragePower Density | Electrode 7.5×14 cm->0.05 W/cm2Electrode 3.2 cm->0.62 W/cm2Electrode 5 cm→0.25 W/cm² | N/A | |
| Waveform Shape | P | N/A | |
| Electrode Size | 7.5×14 cm3.2 cm5 cm | 3 cm7 cm | N/A |
| Number ofChannels | 2 | 2 | N/A |
| Channel Isolation | 1 MOPP (1500V) | - | N/A |
| VMS, VMS Burst | |||
| Intensity - CCMode | 0-200 mA | 0–200 mA | N/A |
| Intensity - CVmode | 0-200 V | 0–200 V | N/A |
| Maximum PhaseDuration | 20-400 µs | 20-400 us | N/A |
| Frequency Range | 1–200 Hz | 1–200 Hz | N/A |
| Maximum AveragePower Density | Electrode 7.5×14 cm→0.05 W/cm²Electrode 3.2 cm->0.62 W/cm2Electrode 5 cm->0.25 W/cm2 | N/A | |
| Current Density | 0.1-25 mA/cm2 | 0.1-30 mA/cm2 | N/A |
| Waveform Shape | N/A | ||
| Device Name | BTL-4000 | Vectra Genisys | Vectra Genisys LaserSystem |
| Manufacturer | BTL Industries, Inc. | Chattanooga Medical Supply, Inc. | Chattanooga MedicalSupply, Inc. |
| 510(k) Number | Current submission | K031077 | K040662 |
| Electrode Size | $7.5\times14$ cm$3.2$ cm$5$ cm | $3$ cm$7$ cm | N/A |
| Number ofChannels | $2$ | $2$ | N/A |
| Channel Isolation | 1 MOPP ( $1500$ V) | - | N/A |
| Laser Module | |||
| Electricalprotection | BF | N/A | B |
| Frequency | $8$ - $10000$ Hz and continuous | N/A | $8$ - $10000$ Hz and continuous |
| Type ofapplicators | probe, cluster | N/A | probe, cluster |
| Laser applicatorsmodels | Probe $830$ nm/ $50$ mWProbe $830$ nm/ $100$ mWProbe $830$ nm/ $200$ mWProbe $830$ nm/ $300$ mWLaser cluster $\rightarrow$ $685$ nm/ $200$ mWLaser cluster $\rightarrow$ $830$ nm/ $800$ mWLaser cluster $\rightarrow$ $830$ nm/ $1300$ mWCombined cluster $\rightarrow$ $685$ nm,$830$ nm/ $1000$ mWCombined cluster $\rightarrow$ $685$ nm,$830$ nm/ $1500$ mW | N/A | $850$ nm/ $100$ mW$850$ nm/ $150$ mW$850$ nm/ $200$ mW$820$ nm/ $300$ mW$670$ nm, $950$ nm Cluster $540$mW$670$ nm, $950$ nm Cluster$1040$ mW$670$ nm, $850$ nm, $950$ nmCluster $415$ mW$670$ nm, $850$ nm, $950$ nmCluster $715$ mW$670$ nm, $850$ nm, $880$ nm,$950$ nm Cluster $1440$ mW |
| Applicators | single diode applicator $0.0314$ cm2cluster $25$ cm2 | N/A | single diode applicator$0.07$ - $0.495$ cm2cluster $7.55$ - $31.2$ cm2 |
| Output Power | $5$ - $1500$ mW (dependent on applicator) | N/A | $100$ - $1440$ mW (dependenton applicator) ( $\pm 20$ %) |
| Duty cycle setting | yes | N/A | yes |
| Wavelength | $685$ - $830$ nm ( $\pm 20$ %) | N/A | $670$ - $950$ nm |
| Ultrasound Module | |||
| ElectricalProtection | Class II, BF | Class I, B | N/A |
| Intensity -Continuous Mode | $0.1$ - $2$ W/cm2 ( $\pm 30$ %) | $0$ – $2.5$ W/cm2 | N/A |
| Intensity - PulsedMode | $0.1$ - $3$ W/cm2 ( $\pm 30$ %) | $0$ - $3$ W/cm2 | N/A |
| Frequency | $1$ MHz ( $\pm 5$ %) | $1$ MHz ( $\pm 5$ %) | N/A |
| $3.1$ MHz ( $\pm 5$ %) | $3.3$ MHz ( $\pm 5$ %) | N/A | |
| Duty Cycle | $6.25$ - $100$ % ( $\pm 30$ %) | $10$ %, $20$ %, $50$ %, Continuous | N/A |
| Pulse Frequency | $10$ — $100$ Hz | $100$ Hz | N/A |
| Ultrasound Heads | $1$ cm2, $5$ cm2, Handsfree Sono $4$ ,Handsfree Sono $6$ | $1$ cm2, $2$ cm2, $5$ cm2, $10$ cm2 | N/A |
| Applicator Size$1$ cm2 Head | Crystal diameter – $1.25$ cmSurface - $1.5$ cm2 | $1$ cm2 | N/A |
| Applicator Size$5$ cm2 Head | Crystal diameter – $2.5$ cmSurface – $7.9$ cm2 | $5$ cm2 | N/A |
| Applicator SizeHandsfree Sono $4$ | Crystal - $3\times1.4$ cmSurface of the applicator - $31.5$ cm2 | - | N/A |
| Device Name | BTL-4000 | Vectra Genisys | Vectra Genisys LaserSystem |
| Manufacturer | BTL Industries, Inc. | Chattanooga Medical Supply, Inc. | Chattanooga MedicalSupply, Inc. |
| 510(k) Number | Current submission | K031077 | K040662 |
| Applicator SizeHandsfree Sono 6 | Crystal - 2.4×1.7 cmSurface of the applicator - 31.5 cm2 | - | N/A |
| Applicator Size2 cm2 Head | - | 2 cm2 | N/A |
| Applicator Size10 cm2 Head | - | 10 cm2 | N/A |
| Crystal Material | • USN 1 cm2→Pz26• USN 5 cm2→Pz26• HandsFree 4→piezoceramic NCE41• HandsFree 6→piezoceramic NCE41 | - | N/A |
| Beam Type | collimated1 cm2 head→1MHz divergent beam | collimated | N/A |
| Temporal MaxPower for PulsedMode | • USN 1 cm2→2.7 W ±20 %• USN 5 cm2→13.2 W ±20 %• HandsFree 4→12.3 W ±20 %• HandsFree 6→12.3 W ±20 % | • USN 1 cm2→3 W ±20 %• USN 2 cm2→6 W ±20 %• USN 5 cm2→15 W ±20 %• USN 10 cm2→30 W ±20 % | N/A |
| Temporal AveragePower forContinuous Mode | • USN 1 cm2→1.8 W ±20 %• USN 5 cm2→8.8 W ±20 %• HandsFree 4→8.2 W ±20 %• HandsFree 6→8.2 W ±20 % | • USN 1 cm2→2.5 W ±20 %• USN 2 cm2→5 W ±20 %• USN 5 cm2→7.5 W ±20 %• USN 10 cm2→25 W ±20 % | N/A |
| InstantaneousPeak Power | • USN 1 cm2→2.7 W ±20 %• USN 5 cm2→13.2 W ±20 %• HandsFree 4→12.3 W ±20 %• HandsFree 6→12.3 W ±20 % | • USN 1 cm2→3 W ±20 %• USN 2 cm2→6 W ±20 %• USN 5 cm2→15 W ±20 %• USN 10 cm2→30 W ±20 % | N/A |
| Temporal MaxEffective Intensity,peak P/ERA | 3 W/cm2 ±30 % | 3 W/cm2 ±20 % | N/A |
| Temporal AverageIntensity | 0.1-2 W/cm2 ±30 % for theoutputintensity higher than 0.2 W/cm2 | 0.1-2 W/cm2 ±20 % | N/A |
| Temporal Peak toAverage Ratio(Rtpa) for PulsedMode | 16:1; 8:1; 4:1; 2:1; 1:1 | 2:1 ±20% at 50% duty cycle5:1 ±20% at 20% duty cycle10:1 ±20% at 10% duty cycle | N/A |
| ErrorUncertainties forthe UltrasonicFrequency | ±5 % | ±5 % | N/A |
| Effective radiatingArea andAccuracy(Beam CrossSection) | • USN 1 cm2→0.9 cm2 ±20 %• USN 5 cm2→4.4 cm2 ±20 %• HandsFree 4→4×4.1 cm2 ±20 %• HandsFree 6→6×4.1 cm2 ±20 % | • USN 1 cm2→0.7-1 cm2• USN 2 cm2→1.4-2 cm2• USN 5 cm2→3.5-5 cm2• USN 10 cm2→6.8-10 cm2 | N/A |
| HandsFree SonoApplicators | • Applicator mode - circular/random(switching between crystals)• Switching period - 0.3 s/0.5 s/0.7 s• Application area -activation/deactivation of crystal pairs(at least one pair)(for safety reasons when you choose onepair of crystals the switching period isfixed to 0.3 s) | N/A | N/A |
| Covering Grade | IP67 | IPX7 | N/A |
| ContactMonitoring | yes | yes | N/A |
| Head Preheating | yes | yes | N/A |
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Image /page/10/Picture/0 description: The image shows a logo with the letters B, T, and L. The letters are in blue and are connected to each other. The logo is made up of three diamond shapes, with each letter inside one of the diamonds. The logo is simple and modern.
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Image /page/11/Picture/0 description: The image shows a logo with three interconnected blue diamonds. The letters "B", "T", and "L" are inscribed within each diamond, respectively. The logo has a clean and modern design.
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Image /page/12/Picture/0 description: The image shows a blue logo with the letters B, T, and L. The letters are inside of three diamond shapes that are linked together. The diamond shapes are all the same size and are evenly spaced apart. The logo is simple and modern.
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Image /page/13/Picture/0 description: The image shows a logo with the letters B, T, and L. The letters are in blue and are inside of three diamond shapes. The diamond shapes are connected to each other. The logo is simple and modern.
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Image /page/14/Picture/0 description: The image shows a blue logo with the letters BTL inside of three diamond shapes. The diamond shapes are connected to each other. The logo is simple and modern. The color blue is used throughout the logo.
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Image /page/15/Picture/0 description: The image shows a logo with three interconnected blue diamonds. The letters "BTL" are arranged within the diamonds, with "B" in the left diamond, "T" in the center diamond, and "L" in the right diamond. The logo has a clean and modern design.
Substantial Equivalence
Based upon the intended use and technical information provided in this pre-market notification, the BTL-4000 device has been shown to be substantially equivalent to currently marketed predicate devices.
Conclusion
Based on the aforementioned information, the BTL-4000 is safe and effective and substantially equivalent to the identified predicate devices.
§ 890.5860 Ultrasound and muscle stimulator.
(a)
Ultrasound and muscle stimulator for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. An ultrasound and muscle stimulator 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. The device also passes electrical currents through the body area to stimulate or relax muscles.(2)
Classification. Class II (performance standards).(b)
Ultrasound and muscle stimulator for all other uses —(1)Identification. An ultrasound and muscle stimulator for all other uses except for the treatment of malignancies is a device that applies to the body ultrasonic energy at a frequency beyond 20 kilohertz and applies to the body electrical currents and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues and the stimulation or relaxation of muscles as described in paragraph (a) of this section.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP for a device described in paragraph (b) of this section is required to be filed with the Food and Drug Administration on or before July 13, 1999 for any ultrasound and muscle stimulator described in paragraph (b) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to an ultrasound and muscle stimulator described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasound and muscle stimulator described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.