Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on microprocessor control and preset/customizable treatment protocols, with no mention of AI or ML capabilities.

Therapeutic

Yes.
The "Intended Use / Indications for Use" section explicitly states that the device is for the "treatment of selected sub-chronic and chronic medical conditions."

Diagnostic

No

The device description and intended use outline therapeutic applications (pain relief, muscle stimulation, etc.), not diagnostic functions. It applies treatment, it does not identify or analyze medical conditions to make a diagnosis.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "two-channel combination unit for therapeutic ultrasound and muscle stimulation" and mentions physical components like an applicator and a membrane panel/touch-sensitive screen. This indicates it is a hardware device with integrated software, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use/Indications for Use: The intended use clearly describes therapeutic applications for treating various medical conditions through physical modalities like ultrasound and electrical stimulation. These are treatments applied to the patient, not tests performed on samples taken from the patient.
Device Description: The device description details a combination unit for therapeutic ultrasound and muscle stimulation, delivering various waveforms for treatment. It does not mention any components or functions related to analyzing biological samples.
Lack of IVD Keywords: There are no mentions of terms typically associated with IVD devices, such as "in vitro," "sample," "assay," "diagnostic," "analysis," "laboratory," etc.

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or screening purposes. This device's function is entirely therapeutic and applied externally to the patient.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Proposed Device Indications for Use (same as those for predicate device):

Therapeutic Ultrasound

Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as;

1. Relief of pain, muscle spasms and joint contractures:
1. Relief of pain, muscle spasms and joint contractures that may be associated with:
- · Adhesive capsulitis
- · Bursitis with slight calcification
- · Myositis
- · Soft tissue injuries
- · Shortened tendons due to past injuries and scar tissues
1. Relief of pain, muscle spasms and joint contractures resulting from:
- · Capsular tightness
- · Capsular tightening

4-Pole Interferential, 2-Pole Interferential, TENS and Microcurrent waveforms

Symptomatic relief of chronic intractable pain 1.
1. Post-traumatic pain
1. Post-surgical pain

EMS, TENS, Hi Volt and Russian waveforms

1. Relaxation of muscle spasms
1. Increase local blood circulation
1. Prevention or retardation of disuse atrophy
1. Muscle re-education
ગ્ Maintaining or increasing range of motion
Q. Immediate post surgical stimulation of calf muscles to prevent venous thrombosis

DC (Direct Current)

Relaxation of muscle spasms 1.

Product codes

IMG, GZJ, GZI, IPF

Device Description

The Sonicator® Plus 920, Model ME 920 is a two-channel combination unit for therapeutic ultrasound and muscle stimulation. The microprocessor controlled Sonicator® Plus 920 provides interferential (4-pole), pre-modulated(2-pole interferential), medium frequency (Russian), EMS, High Volt, TENS, microcurrent and direct current (DC) waveforms with enhanced reliability and ease of use. In addition the Sonicator® Plus 920 offers 1 and 3 MHz ultrasound using dual frequency 5.5 cm2 applicator. An optional 0.9 cm applicator at 1 and 3 MHz is also available.

The two-channel Sonicator® Plus 920 allows the clinician to utilize up to two different waveforms using two channels simultaneously. They can choose between several different amplitude modulation options such as the surge, reciprocation and vector sweep The interferential and pre-modulated modes offer frequency modulation as well as a static frequency option.

The Sonicator Plus provides both a membrane panel and a touchsensitive screen to allow you to quickly set up treatments. 90 preset treatment setups allow quick set up of a treatment that is already in the memory, plus any of these programs may be customized with the clinician's own treatment protocols.

The Sonicator® Plus 920 can provide electrical stimulation only, ultrasound only and combination therapy with the pre-modulated, TENS, High Voltage, microcurrent and DC waveforms.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Clinician

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K071137

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

K111482

ા હાંડ

510(k) SUMMARY

SONICATOR® PLUS 920, ME 920

Submitter's Name: Address:

Mettler Electronics Corp. 1333 South Claudina Street Anaheim, CA 92805

Telephone: Fax:

714-533-2221 X331 714-635-7539

Contact:

Christina Cayuela QS/RA Manager

Date Prepared: March 17, 2011

1

AUG 2 5 2011

Proposed Device Name:

a. TRADE NAME: Sonicator® Plus 920 , Model ME 920 b. CLASSIFICATION NAME: Ultrasound and muscle stimulator (Sec. 890.5860. Product Code IMG) c. COMMON NAME: Combination Ultrasound and Muscle Stimulator

Predicate Device:

TRADE NAME: Sonicator® Plus 940, Model ME 940 510(k) Number: K071137

Description of Proposed Device:

The Sonicator® Plus 920, Model ME 920 is a two-channel combination unit for therapeutic ultrasound and muscle stimulation. The microprocessor controlled Sonicator® Plus 920 provides interferential (4-pole), pre-modulated(2-pole interferential), medium frequency (Russian), EMS, High Volt, TENS, microcurrent and direct current (DC) waveforms with enhanced reliability and ease of use. In addition the Sonicator® Plus 920 offers 1 and 3 MHz ultrasound using dual frequency 5.5 cm2 applicator. An optional 0.9 cm applicator at 1 and 3 MHz is also available.

The two-channel Sonicator® Plus 920 allows the clinician to utilize up to two different waveforms using two channels simultaneously. They can choose between several different amplitude modulation options such as the surge, reciprocation and vector sweep The interferential and pre-modulated modes offer frequency modulation as well as a static frequency option.

The Sonicator Plus provides both a membrane panel and a touchsensitive screen to allow you to quickly set up treatments. 90 preset treatment setups allow quick set up of a treatment that is already in the memory, plus any of these programs may be customized with the clinician's own treatment protocols.

The Sonicator® Plus 920 can provide electrical stimulation only, ultrasound only and combination therapy with the pre-modulated, TENS, High Voltage, microcurrent and DC waveforms.

2

INDICATIONS FOR USE STATEMENT SONICATOR® PLUS 920, ME 920

510(k) Number: K111482

Device Name: Sonicator® Plus 920, Model ME 920

Proposed Device Indications for Use (same as those for predicate device):

Therapeutic Ultrasound

Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as;

1. Relief of pain, muscle spasms and joint contractures:
1. Relief of pain, muscle spasms and joint contractures that may be associated with:
- · Adhesive capsulitis
- · Bursitis with slight calcification
- · Myositis
- · Soft tissue injuries
- · Shortened tendons due to past injuries and scar tissues
1. Relief of pain, muscle spasms and joint contractures resulting from:
- · Capsular tightness
- · Capsular tightening

4-Pole Interferential, 2-Pole Interferential, TENS and Microcurrent waveforms

Symptomatic relief of chronic intractable pain 1.
1. Post-traumatic pain
1. Post-surgical pain

EMS, TENS, Hi Volt and Russian waveforms

1. Relaxation of muscle spasms
1. Increase local blood circulation
1. Prevention or retardation of disuse atrophy
1. Muscle re-education
ഗ് Maintaining or increasing range of motion
Q. Immediate post surgical stimulation of calf muscles to prevent venous thrombosis

DC (Direct Current)

Relaxation of muscle spasms 1.

3

K111482 4 of 15

Comparison of Technological Characteristics Between Proposed and Predicate Devices:

Section 2
1.	510 K #	K071137	K
2.	Device Name	Sonicator® Plus 940	Sonicator® Plus 920
3.	Manufacturer	Mettler Electronics	Mettler Electronics
4.	Power Source	AC line	AC line
	Line Current
Isolation	Reinforced insulation	Reinforced insulation
	Max Leakage Current
(µA)
	Chassis	>50 under SFC	> 50 under SFC
	Electrodes	>50 under SFC	>100 under SFC
5.	Number Of Output
Modes	8	8
6.	Channel(s)	4	2
	Synchronous	1 & 2 or 3 & 4	1 & 2
	Reciprocal	1 & 2 or 3 & 4	1 & 2
	Other	Yes	Yes
7.	Constant Current	Yes	Yes
	Constant Voltage	No	No
8.	Software / Firmware / Yes
Microprocessor
Control		Yes
9.	Automatic Overload
Trip	Yes	Yes
	Automatic Over
Current Trip	Yes	Yes
10.	Automatic No Load
Trip	Yes	Yes
11.	Automatic Shut Off	Yes	Yes
12.	Patient Override
Control Method	No
On/Off, Hold or Stop	No
On/Off, Hold or Stop
13.	Indicator Display
	On / Off Status	Yes	Yes
	Voltage/Current
Level	Yes	Yes
	Low Battery
Indicator	N/A	N/A
14.	Timer Display:	0 - 60 minutes	0 - 60 minutes
15.	Standards
ISO 14971 : 2000	Yes	Yes
	UL 2601-1	Yes	Yes
	CSA C22.2 NO
601.1-M90	Yes	Yes
	IEC/EN 60601-1	Yes	Yes
	IEC/EN 60601-1-2	Yes	Yes
	IEC/EN 60601-2-10	Yes	Yes
	MDD 93/42/EEC,
Annex II	Yes	Yes
16.	Compliance with
21 CFR 898	Yes	Yes
17.	Weight (lbs.)	11	11
18.	Dimensions (in.) Hxw
x L	4.9 x 13.6 x x 10.5	4.9 x 13.6 x x 10.5
19.	Housing Materials &
Construction	Metal Casing	Metal Casing

デ

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Neuromuscular Stimulation, section 3

:

・

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:

| 510 K #
Device Name
Manufacturer · | K071137
---------------------------------------------------|-------------------------------------------------|
| |
| Biphasic |
| Biphasic |
| Pulsed Monophasic and Biphasic | Pulsed Monophasic and Biphasic |
| Biphasic |
| |
| Sinusidal |
| Square |
| Twin spike |
| Gated Sinusoidal | Gated Sinusoidal |
| |
| |
| 50 |
| 50 |
| 155 |
| 50 |
| |
| 115 |
| 110 |
| 170 |
| 110 |
| |
| 120 |
| 115 |
| 220 |
| 120 |
| |
| |
| 100 |
| 100 |
| 310 |
| 100 |
| |
| 58 |
| 55 |
| 85 |
| 55 |
| |
| 12 |
| 12 |
| 22 |
| 12 |
| |
| 500, 250, 200 µs | 500, 250, 200 µs |
| 100 - 600 µs | 100 - 600 µs |
| 10 - 80 µs |
| 400 µs |
| |
| 2 kHz, 4 kHz, 5 kHz | 2 kHz, 4 kHz, 5 kHz |
| |
| 0.5 - 250 Hz | 0.5 - 250 Hz |
| 0.5 - 200 Hz | 0.5 - 200 Hz |
| 2.5 kHz |
| |
| 1 - 250 Hz |
| |
| |
| Yes |
| Yes |
| Yes |
| Yes |
| |
| 250, 125, 100 us | 250, 125, 100 µs |
| 50 - 300 µs |
| 10 - 80 µs |
| 200 us |
| Zero |
| Symmetric |
| Balanced |
| |
| |
| 15.9 |
| 60 |
| 48 |
| 15.9 |
| |
| |
| 2.46 |
| 1.97 |
| 2.32 |
| 3.45 |
| |
| |
| 0.062 |
| 0.039 |
| |
| 0.054 |
| 0.121 |
| |
| |
| N/A |
| 7 |
| 7 |
| N/A |
| |
| N/A |
| 0.5, 0.7, 1, 2, 3, 4, 5, 6, 7 | 0.5, 0.7, 1, 2, 3, 4, 5, 6, 7 |
| 0.5, 0.7, 1, 2, 3, 4, 5, 6, 7 | 0.5, 0.7, 1, 2, 3, 4, 5, 6, 7 |
| 0 - 100 |
| |
| N/A |
| 70 |
| 120 |
| 2, 4, 6......20 | 2, 4, 6......20 |
| |
| N/A |
| 3.6 - 77.8 % | 3.6 - 77.8 % |
| 6.3 % to 85.7 % | 6.3 % to 85.7 % |
| 10, 20, 30, ........100% | 10, 20, 30, ........100% |
| |
| 1 - 99 |
| 1 - 30 |
| 1 - 30 |
| 1 - 30 |
| |
| 1 - 99 |
| 1 - 99 |
| 1 - 99 |
| 1 - 99 |

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Pain Management, Section 3

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ﺃ –

510 K #	K071137	K
Device Name	Sonicator® Plus 940	Sonicator® Plus 920
Manufacturer	Mettler Electronics	Mettler Electronics
Waveform
Interferential, 4-pole	Biphasic	Biphasic
Interferential, 2-pole,
Premodulated	Biphasic	Biphasic
TENS	Biphasic	Biphasic
Microcurrent	Biphasic and pulsed monophasic	Biphasic and pulsed monophasic
Shape
Interferential, 4-pole	Sinusidal	Sinusidal
Interferential, 2-pole,
Premodulated	Sinusidal	Sinusidal
TENS	Square	Square
Microcurrent	Square	Square
Max Output Voltage (V)
±20%
500 Ω
Interferential, 4-pole	48	50
Interferential, 2-pole,
Premodulated	49	50
TENS	46	50
Microcurrent	0.38	0.37
2 kΩ
Interferential, 4-pole	110	115
Interferential, 2-pole,
Premodulated	115	110
TENS	100	115
Microcurrent	1.55	1.5
10 KΩ
Interferential, 4-pole	120	120
Interferential. 2-pole,
Premodulated	120	115
TENS	105	125
Microcurrent	7.5	7.4
Max Output Current
(mA) ±20%
500 Ω
Interferential, 4-pole	96	100
Interferential, 2-pole,
Premodulated	98	100
TENS	90	100
Microcurrent	0.760	0.74
2 kΩ
Interferential, 4-pole	55	58
Interferential, 2-pole,
Premodulated	57	55
TENS	50	58
Microcurrent	0.780	0.75
10 kΩ
Interferential, 4-pole	12	12
Interferential, 2-pole,
Premodulated	12	12
TENS	10.5	13
Microcurrent	0.750	0.74
Pulse Width Range
Interferential, 4-pole	500, 250, 200 μs	500, 250, 200 μs
Interferential, 2-pole,
Premodulated	500, 250, 200 μs	500, 250, 200 μs
TENS	100 - 600 μs	100 - 600 μs
Microcurrent	1.25 ms - 1.67 s	1.25 ms - 1.67 s
Frequency (Hz)
Interferential, 4-pole	2 kHz, 4 kHz, 5 kHz	2 kHz, 4 kHz, 5 kHz
Interferential, 2-pole,
Premodulated	2 kHz, 4 kHz, 5 kHz	2 kHz, 4 kHz, 5 kHz
TENS	0.5 - 250 Hz	0.5 - 250 Hz
Microcurrent	0.3 - 400 Hz	0.3 - 400 Hz
Beat Frequency (Hz)
Interferential, 4-pole	1 - 250 Hz	1 - 250 Hz
Interferential, 2-pole,
Premodulated	1 - 250 Hz	1 - 250 Hz
Multiphasic
Waveforms............
Symmetrical Phases?
Interferential, 4-pole	Yes	Yes
Interferential, 2-pole,	Yes	Yes
Premodulated
TENS	Yes	Yes
Microcurrent	Yes	Yes
Phase Duration
Interferential, 4-pole	250, 125, 100 μs	250, 125, 100 μs
Interferential, 2-pole,
Premodulated	250, 125, 100 μs	250, 125, 100 μs
TENS	50 - 300 μs	50 - 300 μs
Microcurrent	1.25 ms - 1.67 s	1.25 ms - 1.67 s
Net Charge	Zero	Zero
Symmetry	Symmetric	Symmetric
Method	Balanced	Balanced
Maximum Phase Charge
(uC)
500 Ω
Interferential, 4-pole	12.7	15.9
Interferential, 2-pole,
Premodulated	12.7	15.9
TENS	60	60
Microcurrent	75	75
Maximum Current
Density
(mA/cm², 500 Ω)
Interferential, 4-pole	3.50*	3.45
Interferential, 2-pole,
Premodulated	2.96*	2.46
TENS	1.91*	1.97
Microcurrent	0.026*	0.026
Maximum Power Density
(W/cm², 500 Ω)
Interferential, 4-pole	0.121	0.121
Interferential, 2-pole,
Premodulated	0.089	0.062
TENS	0.037	0.039
Microcurrent	0.000007	0.000007
Burst Mode
a. Pulses per burst
Interferential, 4-pole	N/A	N/A
Interferential, 2-pole,	N/A	N/A

Premodulated
TENS	7	7
Microcurrent	N/A	N/A
b. Bursts per second
Interferential, 4-pole	N/A	N/A
Interferential, 2-pole,
Premodulated	N/A	N/A
TENS	0.5, 0.7, 1, 2, 3, 4, 5, 6, 7	0.5, 0.7, 1, 2, 3, 4, 5, 6, 7
Microcurrent	N/A	N/A
c. Burst duration (ms)
Interferential, 4-pole	N/A	N/A
Interferential, 2-pole,
Premodulated	N/A	N/A
TENS	70	70
Microcurrent	N/A	N/A
d. Duty Cycle (b x c)
Interferential, 4-pole	N/A	N/A
Interferential, 2-pole,
Premodulated	N/A	N/A
TENS	3.6 - 77.8 %	3.6 - 77.8 %
Microcurrent	N/A	N/A
On Time (s)
Interferential, 4-pole	N/A	N/A
Interferential, 2-pole,
Premodulated	N/A	N/A
TENS	1 - 30	1 - 30
Microcurrent	N/A	N/A
Off Time (s)
Interferential, 4-pole	N/A	N/A
Interferential, 2-pole,
Premodulated	N/A	N/A
TENS	1 - 99	1 - 99
Microcurrent	N/A	N/A

510 K #
Device Name
Manufacturer	K071137
Sonicator® Plus 940
Mettler Electronics	K
Sonicator® Plus 920
Mettler Electronics
Waveform
Continuous DC	DC	DC
Shape
Continuous DC	DC	DC
Max Output Voltage (V)
±20%
500 Ω
Continuous DC	10.2	10.5
2 kΩ
Continuous DC	28	26
10 kΩ
Continuous DC	34	31
Max Output Current
(mA) ±20%
500 Ω
Continuous DC	20	21
2 kΩ
Continuous DC	14	13
10 kΩ
Continuous DC	3.4**	3.1
Maximum Current
Density
(mA/cm², 500 Ω)
Continuous DC	0.99	0.99
Maximum Power Density
(W/cm², 500 Ω)
Continuous DC	0.0079	0.0098
On Time (s)
Continuous DC	Controlled by probe	Controlled by probe
Off Time (s)
Continuous DC	Controlled by probe	Controlled by probe
510 K #	K071137	K
Device Name	Sonicator® Plus 940	Sonicator® Plus 920
Manufacturer	Mettler Electronics	Mettler Electronics
Power Source	AC Line	AC Line
Standards
ISO 14971 : 2000	Yes	Yes
UL 2601-1	Yes	Yes
CSA C22.2 NO 601.1- M90	Yes	Yes
IEC/EN 60601-1	Yes	Yes
IEC/EN 60601-1-2	Yes	Yes
IEC/EN 60601-2-5	Yes	Yes
FDA, 21 CFR 1050.10	Yes	Yes
MDD 93/42/EEC,
Annex II	Yes	Yes
Timer Accuracy:	$\pm$ 3 %	$\pm$ 3 %
Maximum Treatment
Time:	30 minutes	30 minutes
Ultrasonic Generator Specifications
Frequency	1 MHz and 3 MHz, $\pm$ 5 %	1 MHz and 3 MHz, $\pm$ 5 %
Modes	Continuous and Pulsed	Continuous and Pulsed
Pulse Repetition Rate	100 Hz $\pm$ 10 %	100 Hz $\pm$ 10 %
Pulse Duration	0.5, 1.0, 2.0. 3.0, 4.0 and 5 ms ( $\pm$ 10
%)	0.5, 1.0, 2.0. 3.0, 4.0 and 5 ms ( $\pm$ 10
%)
Temporal Peak/
average intensity
ratio	2:1 $\pm$ 20 % at 50 % Duty Cycle
2.5 :1 $\pm$ 20 % at 40 % Duty Cycle
3.3:1 $\pm$ 20 % at 30 % Duty Cycle
5:1 $\pm$ 20 % at 20 % Duty Cycle
10:1 $\pm$ 20 % at 10 % Duty Cycle
20:1 $\pm$ 20 % at 5 % Duty Cycle	2:1 $\pm$ 20 % at 50 % Duty Cycle
2.5 :1 $\pm$ 20 % at 40 % Duty Cycle
3.3:1 $\pm$ 20 % at 30 % Duty Cycle
5:1 $\pm$ 20 % at 20 % Duty Cycle
10:1 $\pm$ 20 % at 10 % Duty Cycle
20:1 $\pm$ 20 % at 5 % Duty Cycle
Maximum output
power	12 W for ME 9401
1.8 W for ME 9402	12 W for ME 9201
1.8 W for ME 9202
Maximum intensity	2 W/cm² for continuous mode
3 W/cm² for pulsed mode	2 W/cm² for continuous mode
3 W/cm² for pulsed mode

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Muscle Spasm, section 3

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K111482 14 of 15

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Therapeutic Ultrasound

and the comments of the comments of the comments of the comments of the contraction of the contraction of the contribution of the contribution of the contribution of the cont

く

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K1111482 15 of 15

Indication accuracy

1

1 ---

± 20 %

Ultrasonic Applicator Specifications

| Piezoelectric discs | Ultrasound transducer attached to a
metal surface and patient contact
through the metal | Ultrasound transducer attached to a
metal surface and patient contact
through the metal |
|---------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Applicator Part | ME 9401 | ME 9201 |

Frequency	1 MHz and 3 MHz ±5%
Effective Radiating
Area	5.5 cm² (1 MHz) / 6.0 cm² (3 MHz)
Maximum Beam
Non-
Uniformity Ratio	4.55 : 1 maximum

1 MHz and 3 MHz ±5% 5.5 cm² (1 MHz) / 6.0 cm² (3 MHz)

4.6:1 (1 MHz) / 4.2:1 (3 MHz) maximum

| Applicator Part

Number	ME 9402	ME 9202
Frequency	1 MHz and 3 MHz ±5%	1 MHz and 3 MHz ±5%
Effective Radiating
Area	0.9 cm² (1MHz) / 0.9 cm² (3 MHz)	0.9 cm² (1MHz) / 0.8 cm² (3 MHz)
Maximum Beam
Non-
Uniformity Ratio	4.68 : 1 maximum	4.7:1 maximum
Other Applicators	None	None
Frequency	N/A	N/A
Effective Radiating
Area	N/A	N/A
Maximum Beam
Non-
Uniformity Ratio	N/A	N/A

Values shown are current correct values for ME940 device and reported in mA/cm² to match the same mAcm2 nomenclature reported for ME920 device (values appearing in original K071137 submission were in Alcm2)

** Value shown is correct value for ME940 device (value appearing in original K071137 submission was erroneously reported as 17 mA, much higher than the actual correct lower value of 3.4 mA shown above)

15

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/15/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mettler Electronics Corporation % Ms. Christina Cayuela OS/RA Manager 1333 South Claudina Street Anaheim, CA 92805

AUG 25 2011

Re: K111482

Trade/Device Name: Sonicator Plus 920, Model ME 920 Regulation Number: 21 CFR 890.5860 Regulation Name: Ultrasound and muscle stimulator Regulatory Class: II Product Code: IMG, GZJ, GZJ, GZI and IPF Dated: July 20, 2011 Received: July 26, 2011

Dear Ms. Cayuela:

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 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 requirements, including, but not limited to: registration and listing (21

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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Eune S. Keitt

-Sr Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

17

Attachment 1 b

Page__________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): K111482

Device Name:

.

Sonicator® Plus 920, ME 920

Indications for Use:

Therapeutic Ultrasound

Application of therapeutic deep heat for the treatment of selected sub-chronic medical conditions such as;

1. Relief of pain, muscle spasms and joint contractures:
1. Relief of pain, muscle spasms and joint contractures that may be associated with:
- · Adhesive capsulitis
- · Bursitis with slight calcification
- Myositis
- · Soft tissue injuries
- · Shortened tendons due to past injuries and scar tissues
1. Relief of pain, muscle spasms and joint contractures resulting from:
- · Capsular tightness
- · Capsular tightening

4-Pole Interferential, 2-Pole Interferential, TENS and Microcurrent waveforms

1. Symptomatic relief of chronic intractable pain
1. Post-traumatic pain
1. Post-surgical pain

EMS, TENS, Hi Volt and Russian waveforms

1.Relaxation of muscle spasms

1. Increase local blood circulation
Prevention or retardation of disuse atrophy 3.
1. Muscle re-education
ર. Maintaining or increasing range of motion
1. Immediate post surgical stimulation of calf muscles to prevent venous thrombosis

DC (Direct Current)

Relaxation of muscle spasms

veforms

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111482

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

Concurrent of CDRH Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109)

(

OR

Over-The-Counter Use

(Optional Format 1-2-96)