Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute surgical pain
Temporary relaxation of muscle spasm
Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles
Increase of blood flow in the treatment area.
Prevention or retardation of disuse atrophy in post-injury type conditions
Muscle re-education
Maintaining or increasing range of motion

Device Description

The DU857 Dual Frequency Ultrasound Therapy and Muscle Stimulator System is comprised of the following main components:
· A system console including software and control electronics;
· A control and display panel;
· Device accessories including Muscle Stimulator electrodes (ME2221, Mettler Com.), ultrasound applicators (ME7513, Mettler Corp.), acoustic gel (Sonigel, Mettler Corp.) and cables, supplied by Alpha Tech.

The DU857 is a two-channel unit for therapeutic ultrasound and muscle stimulation folded into a specially designed cart. The microprocessor controlled DU857 provides Muscle Stimulator alternating current with enhanced reliability and user friendly interface. The DU857 offers 1 and 3 MHz ultrasound treatment.

The user friendly interface comprises keyboard, touch screen and audio feedback. The screen provides operator information about operation mode and signal intensities. Large control soft knobs on the touch screen make easy adjusting of power for ultrasound and muscle stimulation.

AI/ML Overview

The provided document (K052340) is a 510(k) summary for a medical device called "The DU857 Dual Frequency Ultrasound Therapy and Muscle Stimulator System." This type of submission is for substantiating that a new device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness through clinical trials with specific acceptance criteria as you might see for a high-risk device or novel technology.

The document explicitly states:

"Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows: Not applicable"
"Discussion of Clinical Tests Performed: Not applicable"

This means that the manufacturer did not perform studies with acceptance criteria in the way you're asking, for example, a study to demonstrate a certain level of diagnostic accuracy (like sensitivity, specificity, AUC) or a specific clinical outcome. Instead, substantial equivalence was established by demonstrating that the DU857 has the same intended use and similar technological characteristics to the predicate device (Mettler Electronics Corp., Sonicator Plus 930, Model ME 930, K013192), and that any differences do not raise new questions of safety or effectiveness.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, sample sizes, experts for ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as these types of studies were not performed or reported in this 510(k) submission.

The "acceptance criteria" in this context refer to demonstrating substantial equivalence to a predicate device based on comparison of technical specifications and adherence to relevant safety standards, rather than performance metrics from a diagnostic or interventional study.

Here's what can be extracted based on the provided document and the typical nature of a 510(k) submission for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

Criterion Type (for Substantial Equivalence)	Acceptance Criteria (Implicit for 510(k))	Reported Device Performance (DU857)
Intended Use	Same as predicate (Therapeutic Ultrasound and Neuromuscular Stimulation for specific conditions)	Meets: Same intended use as the predicate device (Sonicator Plus 930).
Technological Characteristics	Substantially similar, or differences do not raise new questions of safety or effectiveness. (e.g., power source, classification, physical specs, output parameters, safety features, standards compliance)	Meets: Generally similar to the predicate device with some differences in specifications (e.g., maximum output current/voltage, frequency range for interferential mode, maximum treatment time for electrical stimulation, specific standards met). These differences were deemed not to raise new safety/effectiveness questions.
Safety Standards Compliance	Compliance with relevant electrical, thermal, and mechanical safety standards (e.g., IEC 60601-1, IEC 60601-2-5, IEC 60601-2-10).	Meets: Compliant with IEC 60601-1, IEC 60601-2-5, IEC 60601-2-10, FCC Part 15-B, EN-55011, FDA 21 CFR 1050.10, MDD 93/42EEC Annex II.
Biocompatibility	Yes (implicit for patient contact materials, if any)	Meets: Stated "Yes".
Sterility	Not used (similar to predicate)	Meets: Stated "Sterilization is not used".

2. Sample size used for the test set and the data provenance:

Not applicable. No clinical "test set" was used as no clinical study was performed for this 510(k) submission. The equivalence was established through technical comparison to the predicate device and adherence to recognized safety standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No ground truth for a test set was established as no clinical study was performed.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. No adjudication method was used as no clinical study was performed.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is an ultrasound and muscle stimulator for physiotherapy, not a diagnostic AI device requiring MRMC studies.

6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done:

Not applicable. This device is a physical therapy device, not an algorithm-based diagnostic or therapeutic system that would have a "standalone performance" study in the typical sense.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable. No clinical ground truth was established or used for performance evaluation in this 510(k). The "ground truth" for this submission concerned the technical specifications and safety profile of the device being equivalent to a predicate.

8. The sample size for the training set:

Not applicable. This device is hardware-based with some software for control, not an AI/ML algorithm that requires a "training set" in the context of machine learning.

9. How the ground truth for the training set was established:

Not applicable. As above, no training set or associated ground truth was relevant for this type of device submission.

Summary

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K052340

EXHIBIT 1

DEC 9 2005

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is:________________________________________________________________________________________________________________________________________________

1. Submitter's Identification:

Alfa Tech Medical Systems Ltd. 5A Kaf Tet Be November St. Apt. 29 Ramat Hanassi, Bat-Yam Israel

Date Summary Prepared: 8 August 2005

Contact Persons:

Mr. Ilan Feferberg COO Alfa Tech Medical Systems, Ltd. 5A Kaf Tet Be November St. Apt. 29 Ramat Hanassi, Bat-Yam Israel +972-3 5049039 Tel: + 972-3 5049039 Fax: E-mail: imft(@zahav.net.il

Mr. Yossi Ben David Alfa Tech QA Manager + 972-9 7711018 Tel: + 972-9 7711019 Fax: E-mail: yossi@ordos.co.il

2. Name of the Device:

a. TRADE NAME: The DU857 Dual Frequency Ultrasound Therapy and Muscle Stimulator System
b. CLASSIFICATION NAME: Ultrasound and Muscle Stimulator
1. Common or Usual Name: Ultrasound Diathermy/Powered Muscle Stimulator

Page 1 of 6

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Predicate Devices Information: 4.

. Mettler Electronics Corp., Sonicator Plus 930, Model ME 930 (K013192)
ડ. Device Description: The DU857 Dual Frequency Ultrasound Therapy and Muscle Stimulator System is comprised of the following main components:
- · A system console including software and control electronics;
- · A control and display panel;

· Device accessories including Muscle Stimulator electrodes (ME2221, Mettler Com.), ultrasound applicators (ME7513, Mettler Corp.), acoustic gel (Sonigel, Mettler Corp.) and cables, supplied by Alpha Tech.

6. Intended Use: (Same as those for predicate device)

Therapeutic Ultrasound

1. Pain relief
1. Reduction of muscle spasm
1. Localized increase of blood flow
1. Increase range of motion of contracted joints using heat and stretch techniques.

Neuromuscular Stimulation

1. Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute surgical pain
1. Temporary relaxation of muscle spasm
1. Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles
1. Increase of blood flow in the treatment area
1. Prevention or retardation of disuse atrophy in post-injury type conditions
1. Muscle re-education
1. Maintaining or increasing range of motion

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Comparison to Predicate Devices: 7.

Comparison of technological characteristics to legally marketed predicate devices is given in the tables below:

Table 1. Comparison of general characteristics to legally marketed predicate

Item for comparison	Description		Comments
	Claimed device	Predicate device
510K #	Pending FDA 510(k) approval	K013192
Device Name	DU857 Dual FrequencyUltrasound Therapy andMuscle Stimulator System	Sonicator Plus 930
Manufacturer	AlfaTech Medical SystemsLtd.	Mettler Electronics
Intended use	Therapeutic Ultrasound andNeuromuscular Stimulation	Therapeutic Ultrasound andNeuromuscular Stimulation
Target population	Patients who needphysiotherapy treatment	Patients who needphysiotherapy treatment
Design	The concept is to combinetwo kinds of physiotherapyunits in one device	The concept is to combinetwo kinds of physiotherapyunits in one device
Materials	Metal enclosure	Metal enclosure
Performance	Use friendly interface, easy tooperate	Use friendly interface, easy tooperate
Sterility	Sterilization is not used	Sterilization is not used
Biocompatability	Yes	Yes
Mechanical Safety	Compliant with mechanicalsafety requirements of IEC60601-1, IEC 60601-2-5, IEC60601-2-10 safety standards	Compliant with mechanicalsafety requirements ofUL2601-1, CSA C22.2 NO601.1-M90, IEC 60601-2-5,IEC 60601-2-10 safetystandards	Mechanical safetyrequirements of IEC60601-1and UL2601-1 are the sameexcept additionalrequirements of UL2601-1cl.55 for polymeric covers.These requirements are notapplicable for DU857 Systembecause such materials arenot used.
Chemical Safety	No chemical hazards	No chemical hazards
Human Factors	For analysis see RiskManagement file
Energy delivered	The delivered energy islimited according torequirements of collateral IEC60601-2-5, IEC 60601-2-10safety standards	The delivered energy islimited according torequirements of collateral IEC60601-2-5, IEC 60601-2-10safety standards	The maximum DU857intensities in ultrasound andelectrotherapy treatment areless than used in SonicatorPlus 930, see table 2
Compatibility withenvironment and otherdevices	The system is used insidebuildings. Interaction withother devices is notperformed	The system is used insidebuildings. Interaction withother devices is notperformed
Used at: (hospital,home, ambulances)	Physiotherapy clinics	Physiotherapy clinics
Standards met	IEC 60601-1, IEC 60601-2-5,IEC 60601-2-10	UL2601-1, CSA C22.2 NO601.1-M90, IEC 60601-2-5,IEC 60601-2-10
Electrical Safety	IEC 60601-1, IEC 60601-2-5,IEC 60601-2-10	UL2601-1, CSA C22.2 NO601.1-M90, IEC 60601-2-5,IEC 60601-2-10
Thermal Safety	IEC 60601-1, IEC 60601-2-5,IEC 60601-2-10	UL2601-1, CSA C22.2 NO601.1-M90, IEC 60601-2-5,IEC 60601-2-10
Radiation Safety	N/A	N/A
Item for comparison	Claimed device	Predicate device
510K #		K013192
Device Name	DU857 Dual Frequency UltrasoundTherapy and Muscle Stimulator System	Sonicator Plus 930
Manufacturer	AlfaTech Medical Systems Ltd.	Mettler Electronics
Power Source	AC line	AC line
Input:	90-132VAC, 50-60Hz,4A; 207-264VAC,50Hz, 2A	90-240VAC, 50-60Hz, 2.3A Nom
Classification	Protective Class I Equipment	Protective Class I Equipment
Year 2000 Compliant	Yes	Yes
Weight (lbs)	165	10
Dimensions (in.) HxW xL	67 in (H) x 26 in (W) x 35 in (D)	6 in (H) x 12 in (W) x 12 in (D)
Housing materials	Aluminum chassis	Aluminum chassis with ABS cover
Construction	Folded into a specially designed cart	Folded into a box shape and seamswelded & ground flush and a stylized ABScover screwed onto metal box
Operating temperature	+50°F to +86°F+10°C to +30°C	+50°F to +104°F+10°C to +40°C
Humidity	Operating, 30% to 75% Relative Humidityat 86°FNonoperating, 20 to 80% RelativeHumidity, noncondensing	Operating, 30% to 75% Relative Humidityat 104°FNonoperating, 5 to 95% RelativeHumidity, noncondensing
Storage temperature	32°F to 113°F0°C to 45°C	-40°F to 167°F-40°C to 75°C
Timer Accuracy	$\pm$ 5 seconds for all times range	$\pm$ 0.5 minutes for times less than 5 minutes$\pm$ 10% for times from 5 to 10 minutes$\pm$ 1.0 minute for times greater than 10minutes
Maximum Treatment Time	30 minutes - ultrasound or combinationtherapy30 minutes - electrical stimulation	30 minutes - ultrasound or combinationtherapy60 minutes - electrical stimulation
Treatment Timer	Treatment time counts down to zero whena time is set, or up to 30 minutes when notime is set. The digital timer indicates theremaining or elapsed treatment timeduring the "Hold" period.	Treatment time counts down to zero whena time is set, or up to 60 or 30 minuteswhen no time is set. The digital timerindicates the remaining or elapsedtreatment time during the "Hold" period.
Item for comparison	Neuromuscular Stimulation
510K #		K013192
Standards
UL544	No	No
UL2601-1-UL	No	Yes
CUL	No	No
CSA C22.2 NO 601.1-M90	No	Yes
IEC 60601-1	Yes	No
IEC 60601-2-10	Yes	Yes
FCC Part 15-B	Yes	Yes
EN-55011 (CISPR-11)	Yes	Yes
FDA, 21 CFR 1050.10	Yes	Yes
MDD 93/42EEC, Annex II	Yes	Yes
Timer settings	1-30 minutes $\pm$ 1%	1-60 minutes $\pm$ 5%
Automatic Shut Off	Yes	Yes
Number of output modes	1	3
Channel(s)	2	2
Synchronous	1&2	1&2
Reciprocal	No	Yes
Other	No	Yes
Computerized SoftwareProvided	Yes	N/A

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Table 2. Comparison of technological characteristics to legally marketed predicate

Page 4 of 6

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Constant Current	No	Yes
Constant Voltage	No	No
Max Output Current (mA)	0-36±10% mA RMS, max.,1Kohm load, Muscle Stimulator mode	0-65±10% mA RMS, max.,1Kohm load, Muscle Stimulator mode
	N/A	0-50±10% mA RMS, max.,1Kohm load, premodulated and mediumfrequency modes
	N/A	0-99±10% mA peak, max.,1Kohm load, biphasic mode
	N/A	0-2500±10% mA peak, max.,1Kohm load, high volt mode
	N/A	10-990±10 μA peak,1Kohm load, microamp mode
Max output Voltage (V)	0-36±30% volts RMS,1Kohm load, Muscle Stimulator mode	0-65±10% volts RMS,1Kohm load, Muscle Stimulator mode
	N/A	0-50±10% volts RMS,1Kohm load, premodulated and mediumfrequency modes
	N/A	99±10% volts peak,1Kohm load, biphasic mode
	N/A	0-500±10% volts peak,1Kohm load, high volt mode
	N/A	1.0±10% volt peak,1Kohm load, microamp mode
Frequency range	4800-5050 Hz ±1%(Interferential mode)	4000-4250 Hz ±1%(Interferential andPremodulated modes)2500 Hz ±2%(Medium frequency mode)
Electrodes	ME2221	ME2221
Waveforms & Channels
All Channels	Interferential	Premodulated, Medium Frequency,Biphasic
Channel 1 & 2	Muscle Stimulator	Muscle Stimulator
Channel 1	Muscle Stimulator	Combination Therapy and all others
Channel 2	Muscle Stimulator	All
Output Displays	Two simultaneously, amber channelactive indicators	Two simultaneously, amber channelactive indicators
Channel Isolation	Yes	Yes
Line Current Isolation	Yes	Yes
Automatic Overload Trip	Yes	Yes
Current/Voltage level	50 mA RMS, Muscle Stimulator modeN/A	70 mA RMS, Muscle Stimulator mode55 mA RMS, premodulated and mediumfrequency mode
Automatic No Load Trip	Yes	Yes
Patient Override	None	None
Control Method	On/Off	On/Off or hold
Max Leakage Current(μΑ)
Chassis	<100	<100
Electrodes	<100	<100
Indicator Display Unit	Functioning	Yes	Yes
Low Battery Indicator	N/A	N/A
Therapeutic Ultrasound
510K #		K013192
Standards
UL544	No	No
UL2601-1-UL	No	Yes

{5}------------------------------------------------

CUL	No	No
CSA C22.2 NO 601.1-M90	No	Yes
IEC 60601-1	Yes	No
IEC 60601-2-5	Yes	Yes
FCC Part 15-B	Yes	Yes
EN-55011 (CISPR-11)	Yes	Yes
FDA, 21 CFR 1050.10	Yes	Yes
MDD 93/42EEC, Annex II	Yes	Yes
Ultrasonic GeneratorSpecifications
Frequency	$1 MHz±5%$	$1 MHz±5%$
	$3 MHz±5%$	$3 MHz±5%$
Modes	Continuous	Continuous
		Pulsed - 20% duty cycle
		Pulsed - 50% duty cycle
Pulse Repetition Rate	Not applicable	$100 Hz±20%$
Pulse Duration	Not applicable	2 msec±20%, 20% duty cycle
Temporal Peak/averageintensity ratio	Not applicable	5:1±20%, 20% duty cycle
		2:1±20%, 50% duty cycle
Maximum Output Power	7.5 W with a $5 cm^2$ applicator, (ME 7513)	11 W with a $5 cm^2$ applicator, (ME 7513)
Maximum Intensity	$1.5 W/cm^2$	$2.2 W/cm^2$
Indication Accuracy	±20% (for any level above 10% ofmaximum)	±20% (for any level above 10% ofmaximum)
Ultrasonic ApplicatorSpecifications
Piezoelectric Disks	The output transducer utilizes a bariumtitanate disc with a specially coated face	The output transducer utilizes a bariumtitanate disc with a specially coated face
Applicator Part Number	ME7513	ME7513
Frequency	1 or 3 MHz±5%	1 or 3.2 MHz±5%
Effective Radiating Area	$5 cm^2±10%$	$5 cm^2±10%$
Maximum Beam Non-Uniformity Ratio	6:1	6:1

8. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows: Not applicable

9. Discussion of Clinical Tests Performed: Not applicable

10. Conclusions:

The DU857 Dual Frequency Ultrasound Therapy and Muscle Stimulator System has the same intended use and similar characteristics as the predicate device, the Sonicator Plus ® 930, Model ME 930 device. Moreover, bench testing and non-clinical testing documentation supplied in this submission demonstrates that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the Alfa Tech Medical Systems Ltd. DU857 Dual Frequency Ultrasound Therapy and Muscle Stimulator System is substantially equivalent to the predicate device.

Page 6 of 6

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, on the right side. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus. The seal is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 9 2005

Alfa Tech Medical Systems, Ltd. c/o Ms. Susan D. Goldstein-Falk Official Correspondent mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, New York 11021

Re: K052340

Trade/Device Name: The DU857 Dual Frequency Ultrasound Therapy and Muscle Stimulator System Regulation Number: 21 CFR 890.529 Regulation Name: Ultrasound and Muscle Stimulator Regulatory Class: II Product Codes: IMG, IMI, IPF, LIH Dated: November 22, 2005 Received: November 23, 2005

Dear Ms. Goldstein-Falk:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your soctor s retty production is substantially equivalent (for the indications for relerenced above and nave decemined are devices marketed in interstate commence use stated in the encrosure/ to regally manistal Device Amendments, or to devices that provision in May 26, 1770, the onacthern with the provisions of the Federal Food, Drug, and Cosmetic flave been reclassified in accordance the me me market approval application (PMA). You may, Act (Act) that do not require approvate of the general controls provisions of the Act. The general therefore, market the device, sabject or anual registration, listing of devices, good controls provisions of the necessed prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see acorrols. Existing major regulations affecting your device can be may be subject to such additional controls. "Line 11, 2008. 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 FICA 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 CEP Box 907). Federal statutes and regulations administration and listing (21 CFR Part 807); the Act 3 requirements, morading, earling practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

{7}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin manieting of substantial equivalence of your device to a legally premarket noutheation: "The PDF Intentig sification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you ucate specific advice 10. Jour 2019 276-0120. Also, please note the regulation entitled, Colliact the Office of Ochphanes as (210) fication" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, general information on your respension its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Signature

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Exhibit B

Page 1 of 1

510(k) Number (if known): K052340

Device Name: The DU857 Dual Frequency Ultrasound Therapy and Muscle Stimulator System

Indications For Use:

. ...

Therapeutic Ultrasound:

1. Pain relief
1. Reduction of muscle spasm
1. Localized increase of blood flow
1. Increase range of motion of contracted joints using heat and stretch techniques.

Neuromuscular Stimulation:

1. Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute surgical pain
1. Temporary relaxation of muscle spasm
1. Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles
1. Increase of blood flow in the treatment area.
1. Prevention or retardation of disuse atrophy in post-injury type conditions
1. Muscle re-education
1. Maintaining or increasing range of motion

Prescription Use X (Per 21 CFR 801 Subpart D) OR

Over-The Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

(Division of the of CDRH, Office of Device Evaluation (ODE) Division of General, Restorative, and Neurological Devices

510(k) Number K052340

Regulation Number and Section

§ 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.