K Number

Device Name

Manufacturer

METTLER ELECTRONICS CORP.

Date Cleared

2007-08-01

(99 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K984142,K031077

Predicate For

K092627,K093138,K111482,K171978

Intended Use

Therapeutic Ultrasound:

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
Myositis
Soft tissue injuries
Shortened tendons due to past injuries and scar tissues

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
Post-traumatic pain
Post-surgical pain

EMS, TENS, Hi Volt and Russian waveforms:

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

DC (Direct Current):
Relaxation of muscle spasms

Device Description

The Sonicator® Plus 940 , Model ME 940 is a four-channel combination unit for therapeutic ultrasound and muscle stimulation. The microprocessor controlled Sonicator Plus 940 provides premodulated medium frequency and symmetrical biphasic waveforms with enhanced reliability and ease of use. In addition the Sonicator Plus 940 offers 1 and 3 MHz ultrasound using a variety of interchangeable applicators.

The four-channel Sonicator Plus 940 allows the clinician to utilize up to two different waveforms using four channels simultaneously. The clinician can choose between several different amplitude modulation options such as the surge, reciprocation and amplitude modulation (interferential only, vector rotation). The interferential and premodulated modes offer frequency modulation as well as a static frequency option.

The membrane panel provides both tactile and audio feedback when buttons are pressed. Blinking LED's guide the operator through the easy setup routine.

Large, soft-touch control knobs make adjusting power for ultrasound and stimulation easy to accomplish with no guesswork involved. A large LCD output display allows the clinician to monitor four channels simultaneously for four channel combination treatment protocols. It also allows the operator to adjust both channels of an interferential protocol simultaneously while monitoring the current.

The Sonicator Plus 940 can provide electrical stimulation only. ultrasound only and combination therapy with the pre-modulated, biphasic and medium frequency waveforms

AI/ML Overview

The provided document is a 510(k) summary for the SONICATOR® PLUS 940, Model ME 940, an ultrasound and muscle stimulator device. The purpose of this summary is to demonstrate substantial equivalence to predicate devices, not to perform a clinical effectiveness study. As such, the document does not contain acceptance criteria for clinical performance, nor does it describe a study to prove the device meets such criteria.

Instead, the document focuses on comparing the technological characteristics and intended uses of the proposed device to two predicate devices: Sonicator® Plus 994, Model ME 994 (K984142) and Chattanooga Vectra Genesis (K031077). The underlying assumption for 510(k) clearance is that if the new device is substantially equivalent in terms of technology, safety, and intended use to a legally marketed device, it does not require new clinical performance data to enter the market.

Therefore, many of the requested elements for describing an acceptance criteria study (like sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information) are not applicable or present in this type of regulatory submission.

However, I can extract the comparative information presented in the document, which serves as the basis for demonstrating equivalence in a 510(k) submission.

Comparative Information between Proposed and Predicate Devices

The "acceptance criteria" in this context are effectively the demonstrated characteristics and performance parameters that are comparable to the predicate devices, thereby establishing substantial equivalence. The "study" proving this is the detailed comparison provided in the 510(k) submission.

1. Table of "Acceptance Criteria" (Predicate Device Performance) and Reported Device Performance (Proposed Device)

The document provides extensive tables comparing the technical specifications of the Sonicator® Plus 940 (Proposed Device) with the Chattanooga Vectra Genesis (Predicate Device K031077) for Neuromuscular Stimulation, Pain Management, Muscle Spasm, and Therapeutic Ultrasound. The "acceptance criteria" here are essentially the specifications of the predicate device. If the proposed device meets or is comparable to these specifications, it is deemed acceptable for marketing.

Example Excerpts from Comparison Tables:

Characteristic (Acceptance Criteria - Predicate K031077)	Sonicator® Plus 940 (Proposed Device Performance)
NEUROMUSCULAR STIMULATION
Waveform
EMS (Premod, Vectra): Biphasic	Biphasic
TENS (VMS, Vectra): Biphasic	Biphasic
Hi Volt: Pulsed Monophasic	Pulsed Monophasic and Biphasic
Russian: Biphasic	Biphasic
Shape
EMS (Premod, Vectra): Sinusoidal	Sinusoidal
TENS (VMS, Vectra): Square	Square
Hi Volt: Twin spike	Twin spike
Russian: Gated Sinusoidal	Gated Sinusoidal
Max Output Voltage (V) ±20% @ 500 Ω
EMS (Premod, Vectra): 55	49
Hi Volt: 544	146
PAIN MANAGEMENT
Waveform
Interferential, 4-pole: Biphasic	Biphasic
TENS: Biphasic	Biphasic
Max Output Current (mA) ±20% @ 500 Ω
Interferential, 4-pole: 114	96
Microcurrent: 0.960	0.760
THERAPEUTIC ULTRASOUND
Frequency: 1 MHz and 3.3 MHz, ± 5%	1 MHz and 3 MHz, ± 5%
Modes: Continuous and Pulsed	Continuous and Pulsed
Maximum Output Power: 20 W for 10 cm² at 1 Mhz only	N/A (12 W for ME 9401, 1.8 W for ME 9402)
Maximum Intensity: 2.5 W/cm² for continuous mode	2 W/cm² for continuous mode
Effective Radiating Area: 5 cm² appl. ERA of 4 cm²	5.5 cm² (1 MHz) / 6.0 cm² (3 MHz)

Note: The tables clearly show differences in some parameters (e.g., maximum output voltage/current, maximum power/intensity for ultrasound). The 510(k) process accepts such differences as long as they do not raise new questions of safety and effectiveness and the device remains substantially equivalent for its intended use. The submission implicitly argues that these differences are not significant enough to warrant new clinical trials.

2. Sample Size Used for the Test Set and the Data Provenance:
Not applicable as this is a 510(k) premarket notification demonstrating substantial equivalence based on technical and performance comparisons to predicate devices, not a clinical study involving test sets of patients or data. The "data" here refers to the device's measured technical specifications. The provenance is internal testing performed by Mettler Electronics Corp. to establish these specifications.

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 based on expert consensus for clinical outcomes was established as part of this 510(k) submission. The "ground truth" for the technical specifications is the output measured by the manufacturer against industry standards and the predicate device's published specifications.

4. Adjudication Method for the Test Set:
Not applicable. No clinical test set or adjudication process for clinical outcomes was part of this regulatory submission.

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, not an AI-powered diagnostic tool. Therefore, MRMC studies are irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device for therapeutic purposes; it is not an algorithm, and the concept of "standalone performance" in this context is not relevant for a 510(k) based on substantial equivalence. Its performance is measured by its physical output (e.g., electrical stimulation parameters, ultrasound intensity).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" in this context refers to the technical specifications and performance characteristics of the device itself (e.g., voltage, current, frequency, power output, accuracy of timing). This "ground truth" is established through engineering and electrical testing, adhering to recognized standards (e.g., ISO, UL, CSA, IEC/EN, 21 CFR) and measurements against the predicate device's reported specifications.

8. The sample size for the training set:
Not applicable. This is not a machine learning or AI device.

9. How the ground truth for the training set was established:
Not applicable. No training set was used.

Summary

{0}------------------------------------------------

K071137

510(k) SUMMARY

SONICATOR® PLUS 940, ME 940, K (

AUG - 1 2007

)

and the contraction of the count

Submitter's Name:	Mettler Electronics Corp.
Address:	1333 South Claudina Street
	Anaheim, CA 92805

714-533-2221 x324 Telephone: 714-533-3860 Fax:

Robert E. Fleming Contact: Director, Regulatory Affairs
.
September April 16, 2007 Date Prepared:

{1}------------------------------------------------

Proposed Device Name:

a. TRADE NAME: Sonicator® Plus 940 , Model ME 940

b. CLASSIFICATION NAME: Ultrasound and muscle stimulator (Sec. 890.5860, Product Code IMG)

c. COMMON NAME: Combination Ultrasound and Muscle Stimulator

Predicate Devices:

a. TRADE NAME: Sonicator® Plus 994, Model ME 994
b. 510(k) Number: K984142
c. TRADE NAME: Chattanooga Vectra Genesis
d. 510(k) Number: K031077

Description of Proposed Device:

The membrane panel provides both tactile and audio feedback when buttons are pressed. Blinking LED's guide the operator through the easy setup routine.

{2}------------------------------------------------

The Sonicator Plus 940 can provide electrical stimulation only. ultrasound only and combination therapy with the pre-modulated, biphasic and medium frequency waveforms

Proposed Device Intended Use Statement:

Device Name: Sonicator® Plus 940, Model ME 940

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

Therapeutic Ultrasound

1. Pain relief
1. Reduction of muscle spasm
1. Localized increase in 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 post surgical pain (Interferential and Pre-modulated waveforms)
1. Temporary relaxation of muscle spasm (all waveforms)
1. Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles (all waveforms)
1. Increase of blood flow in the treatment area (all waveforms)
1. Prevention or retardation of disuse atrophy in post-injury type conditions (all waveforms)
1. Muscle re-education (all waveforms)
1. Maintaining or increasing range of motion (all waveforms)

Biocompatibility Certification: Electrodes to be provided with this device are the same as those previously submitted since 1997 with Mettler Electronics Corp. devices: Sonicator Plus 992/994 (K984142); SysStim 226 (K964028); SysStim 294 (K984114); and Sonicator Plus 930 (K013192).

{3}------------------------------------------------

Comparison of Technological Characteristics Between Proposed and Predicate Devices:

	Section 2
1.	510 K #	K	K031077
2.	Device Name	Sonicator Plus 940	Vectra Genesis
3.	Manufacturer	Mettler Electronics	Encore Medical(Chattanooga Group)
4.	Power Source	AC line	AC line or optional battery pack
	Line CurrentIsolation	Reinforced insulation	Not Stated in the Manual
	Max Leakage Current(μΑ)
	Chassis	>50 under SFC	Not Stated in the Manual
	Electrodes	>50 under SFC	Not Stated in the Manual
5.	Number Of OutputModes	8	10
6.	Channel(s)	4	4
	Synchronous	1 & 2 or 3 & 4	1 & 2 or 3 & 4
	Reciprocal	1 & 2 or 3 & 4	1 & 2 or 3 & 4
	Other	Yes	Yes
7.	Constant Current	Yes	Optional
	Constant Voltage	No	Optional
8.	Software / Firmware /MicroprocessorControl	Yes	Yes
9.	Automatic OverloadTrip	Yes	Not Stated in the Manual
10.	Automatic OverCurrent Trip	Yes	Warning only, Overcurrent
11.	Automatic No LoadTrip	Yes	Warning only, Bad electrode contact
12.	Automatic Shut Off	Yes	Yes
13.	Patient OverrideControl Method	NoOn/Off, Hold or Stop	YesPatient interrupt switch
14.	Indicator DisplayOn / Off Status	Yes	Yes
	Voltage/CurrentLevel	Yes	Yes
	Low BatteryIndicator	N/A	Yes
15.	Timer Display:	0 - 60 minutes	0 - 60 minutes

	ISO 14971 : 2000	Yes	Not Stated in the Manual
	UL 2601-1	Yes	Not Stated in the Manual
	CSA C22.2 NO601.1-M90	Yes	Not Stated in the Manual
	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 with21 CFR 898	Yes	Yes
17.	Weight (lbs.)	11	7
18.	Dimensions (in.) H x Wx L	4.9 x 13.6 x 10.5	8.8 x 11.375 x 12.75
19.	Housing Materials &Construction	Metal Casing	Not stated in the Manual

Standards

: 上

{4}------------------------------------------------

Neuromuscular Stimulation, section 3

510 K #Device NameManufacturer	KSonicator Plus 940Mettler Electronics	K031077Vectra GenisysEncore Medical(Chattanooga Group)
Waveform
EMS (Premod, Vectra)	Biphasic	Biphasic
TENS (VMS, Vectra)	Biphasic	Biphasic
Hi Volt	Pulsed Monophasic and Biphasic	Pulsed Monophasic
Russian	Biphasic	Biphasic
Shape
EMS (Premod, Vectra)	Sinusidal	Sinusidal
TENS (VMS, Vectra)	Square	Square
Hi Volt	Twin spike	Twin spike
Russian	Gated Sinusoidal	Gated Sinusoidal
Max Output Voltage (V)±20%
500 Ω
EMS (Premod, Vectra)	49	55
TENS (VMS, Vectra)	46	Not stated in the manual
Hi Volt	146	544
Russian	50	56.5
2 kΩ
EMS (Premod, Vectra)	115	216
TENS (VMS, Vectra)	100	Not stated in the manual
Hi Volt	155	580
Russian	110	456
10 kΩ
EMS (Premod, Vectra)	120	260
TENS (VMS, Vectra)	105	Not stated in the manual
Hi Volt	190	612
Russian	120	520
Max Output Current (mA) ±20%
500 Ω
EMS (Premod, Vectra)	98	200
TENS (VMS, Vectra)	90	200
Hi Volt	292	1088
Russian	100	113
2 kΩ
EMS (Premod, Vectra)	57	108
TENS (VMS, Vectra)	50	Not stated in the manual
Hi Volt	78	290
Russian	55	114
10 kΩ
EMS (Premod, Vectra)	12	26
TENS (VMS, Vectra)	10.5	Not stated in the manual
Hi Volt	19	61
Russian	12	26
Pulse Width Range
EMS (Premod, Vectra)	500, 250, 200 μs	400, 250, 200 μs
TENS (VMS, Vectra)	100 - 600 μs	40 - 800 μs
Hi Volt	10 - 80 μs	5 μs
Russian	400 μs	400 μs
Frequency (Hz)
EMS (Premod, Vectra)	2 kHz, 4 kHz, 5 kHz	2.5 kHz, 4 kHz, 5 kHz
TENS (VMS, Vectra)	0.5 - 250 Hz	1 - 200 Hz
Hi Volt	0.5 - 200 Hz	10 - 120 Hz
Russian	2.5 kHz	2.5 kHz
Beat Frequency (Hz)
Interferential, 2-pole,	1 - 250 Hz	1 - 200 Hz
Premodulated
Multiphasic
Waveforms............
Symmetrical Phases?
EMS (Premod, Vectra)	Yes	Yes
TENS (VMS, Vectra)	Yes	Yes
Hi Volt	Yes	No
Russian	Yes	Yes
Phase Duration
EMS (Premod, Vectra)	250, 125, 100 μs	200, 125, 100 μs
TENS (VMS, Vectra)	50 - 300 μs	20 - 400 μs
Hi Volt	10 - 80 μs	Not stated in the manual
Russian	200 μs	200 μs
Net Charge	Zero	Zero (Not Hi Volt)
Symmetry	Symmetric	Symmetric (Not Hi Volt)
Method	Balanced	Balanced (Not Hi Volt)
Maximum Phase Charge(μC)
500 Ω
EMS (Premod, Vectra)	12.7	24.2
TENS (VMS, Vectra)	60	Not stated in the manual
Hi Volt	48	4.9
Russian	12.7	Not Stated in the Manual
Maximum CurrentDensity
(mA/cm², 500 Ω)
EMS (Premod, Vectra)	0.02	3.84
TENS (VMS, Vectra)	0.002	Not stated in the manual
Hi Volt	0.002	59.08
Russian	2.9	Not stated in the manual
Maximum Power Density
(W/cm², 500 Ω)
EMS (Premod, Vectra)	0.089	0.149
TENS (VMS, Vectra)	0.037	Not stated in the manual
Hi Volt	0.035	32.14
Russian	0.121	Not stated in the manual
Burst Mode
a. Pulses per burst
EMS (Premod, Vectra)	N/A	N/A
TENS (VMS, Vectra)	7	7
Hi Volt	7	N/A
Russian	N/A	N/A
b. Bursts per second
EMS (Premod, Vectra)	N/A	N/A
TENS (VMS, Vectra)	0.5, 0.7, 1, 2, 3, 4, 5, 6, 7	1 - 4
Hi Volt	0.5, 0.7, 1, 2, 3, 4, 5, 6, 7	N/A
Russian	0 - 100	20 - 100
c. Burst duration (ms)
EMS (Premod, Vectra)	N/A	N/A
TENS (VMS, Vectra)	70	172
Hi Volt	120	N/A
Russian	2, 4, 6......20	2, 4, 6......10
d. Duty Cycle (b x c)
EMS (Premod, Vectra)	N/A	N/A
TENS (VMS, Vectra)	3.6 - 77.8 %	N/A
Hi Volt	6.3 % to 85.7 %	N/A
Russian	10, 20, 30, ......100%	10, 20, 30, 40, 50%
On Time (ms)
EMS (Premod, Vectra)	1 - 99	5, 4, 10
TENS (VMS, Vectra)	1 - 30	5, 4, 10
Hi Volt	1 - 30	5, 4, 10
Russian	1 - 30	5, 4, 10
Off Time (s)
EMS (Premod, Vectra)	1 - 99	5, 12, 10, 20, 30, 50
TENS (VMS, Vectra)	1 - 99	5, 12, 10, 20, 30, 50
Hi Volt	1 - 99	5, 12, 10, 20, 30, 50
Russian	1 - 99	5, 12, 10, 20, 30, 50

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

and the comments of the count

Page 6 of 15

{6}------------------------------------------------

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

Pain Management, section 3

510 K #	K	K031077
Device Name	Sonicator Plus 940	Vectra Genisys
Manufacturer	Mettler Electronics	Encore Medical(Chattanooga Group)

Waveform

{8}------------------------------------------------

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	57
Interferential, 2-pole,Premodulated	49	55
TENS	46	51
Microcurrent	0.38	0.48
2 kΩ
Interferential, 4-pole	110	108
Interferential, 2-pole,Premodulated	115	216
TENS	100	191
Microcurrent	1.55	1.92
10 kΩ
Interferential, 4-pole	120	260
Interferential, 2-pole,Premodulated	120	260
TENS	105	268
Microcurrent	7.5	9.8
Max Output Current(mA) ±20%
500 Ω
Interferential, 4-pole	96	114
Interferential, 2-pole,Premodulated	98	110
TENS	90	102
Microcurrent	0.760	0.960
2 kΩ
Interferential, 4-pole	55	108
Interferential, 2-pole,Premodulated	57	108
TENS	50	96
Microcurrent	0.780	0.960
10 kΩ
Interferential, 4-pole	12	26
Interferential, 2-pole,Premodulated	12	26
TENS	10.5	26.8
Microcurrent	0.750	0.980
Pulse Width Range
Interferential, 4-pole	500, 250, 200 µs	400, 250, 200 µs
Interferential, 2-pole,Premodulated	500, 250, 200 µs	400, 250, 200 µs
TENS	100 - 600 µs	40 - 2000 µs
Microcurrent	1.25 ms - 1.67 s	1 ms - 10 s
Frequency (Hz)
Interferential, 4-pole	2 kHz, 4 kHz, 5 kHz	2.5 kHz, 4 kHz, 5 kHz
Interferential, 2-pole,Premodulated	2 kHz, 4 kHz, 5 kHz	2.5 kHz, 4 kHz, 5 kHz
TENS	0.5 - 250 Hz	1 - 250 Hz
Microcurrent	0.3 - 400 Hz	0.1 - 1000 Hz
Beat Frequency (Hz)
Interferential, 4-pole	1 - 250 Hz	1 - 200 Hz
Interferential, 2-pole,Premodulated	1 - 250 Hz	1 - 200 Hz
MultiphasicWaveforms............
Symmetrical Phases?
Interferential, 4-pole	Yes	Yes
Interferential, 2-pole,Premodulated	Yes	Yes
TENS	Yes	Yes
Microcurrent	Yes	Yes
Phase Duration
Interferential, 4-pole	250, 125, 100 µs	200, 125, 100 µs
Premodulated
TENS	50 - 300 µs	20 - 1000 µs
Microcurrent	1.25 ms - 1.67 s	0.5 ms - 5 s
Net Charge	Zero	Zero
Symmetry	Symmetric	Symmetric
Method	Balanced	Balanced

{9}------------------------------------------------

{10}------------------------------------------------

Maximum Phase Charge(uC)
500 Ω
Interferential, 4-pole	12.7	25.0
Interferential, 2-pole,Premodulated	12.7	24.2
TENS	60	204
Microcurrent	75	Not Available
Maximum CurrentDensity
(mA/cm², 500 Ω)
Interferential, 4-pole	2.9	3.98
Interferential, 2-pole,Premodulated	0.02	3.84
TENS	0.002	5.03
Microcurrent	0.00003	Not Available
Maximum Power Density
(W/cm², 500 Ω)
Interferential, 4-pole	0.121	0.16
Interferential, 2-pole,Premodulated	0.089	0.149
TENS	0.037	0.257
Microcurrent	0.000007	Not Available
Burst Mode
a. Pulses per burst
Interferential, 4-pole	N/A	N/A
Interferential, 2-pole,Premodulated	N/A	N/A
TENS	7	7
Microcurrent	N/A	N/A
b. Bursts per second

{11}------------------------------------------------

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	1-4
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	172
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 %	N/A
Microcurrent	N/A	N/A
On Time (s)
Interferential, 4-pole	N/A	N/A
Interferential, 2-pole,Premodulated	N/A	5, 4, 10
TENS	1 - 30	N/A
Microcurrent	N/A	N/A
Off Time (s)
Interferential, 4-pole	N/A	N/A
Interferential, 2-pole,Premodulated	N/A	5, 12, 10, 20, 30, 50
TENS	1 - 99	N/A
Microcurrent	N/A	N/A

Muscle Spasm, section 3

510 K #Device NameManufacturer	KSonicator Plus 940Mettler Electronics	K031077Vectra GenisysEncore Medical(Chattanooga Group)
Waveform
Continuous DCShape	DC	DC

{12}------------------------------------------------

Continuous DC	DC	DC
Max Output Voltage (V) ±20%
500 Ω
Continuous DC	10.2	2
2 kΩ
Continuous DC	28	8
10 kΩ
Continuous DC	34	41.6
Max Output Current (mA) ±20%
500 Ω
Continuous DC	20	4
2 kΩ
Continuous DC	14	4
10 kΩ
Continuous DC	17	4
Maximum Current Density (mA/cm², 500 Ω)
Continuous DC	0.99	Not stated in the manual
Maximum Power Density (W/cm², 500 Ω)
Continuous DC	0.0079	Not stated in the manual
On Time (s)
Continuous DC	Controlled by probe	5, 4, 10
Off Time (s)
Continuous DC	Controlled by probe	5, 12, 10, 20, 30, 50

Therapeutic Ultrasound

510 K #Device NameManufacturer	KSonicator Plus 940Mettler Electronics	K031077Vectra GenisysEncore Medical(Chattanooga Group)
Power Source	AC Line	AC Line
StandardsISO 14971 : 2000	Yes	Not Stated in the Manual

{13}------------------------------------------------

UL 2601-1	Yes	Not Stated in the Manual
CSA C22.2 NO 601.1-	Yes	Not Stated in the Manual
M90
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	Not Stated in the Manual
MDD 93/42/EEC,Annex II	Yes	Yes
Timer Accuracy:	$\u00b1 3 %$	Not stated in the Manual
Maximum TreatmentTime:	30 minutes	30 minutes
Ultrasonic Generator Specifications
Frequency	1 MHz and 3 MHz, $\u00b1 5 %$	1 MHz and 3.3 MHz, $\u00b1 5 %$
Modes	Continuous and Pulsed	Continuous and Pulsed
Pulse Repetition Rate	100 Hz $\u00b1 10 %$	100 Hz
Pulse Repetition Rate	100 Hz ± 10 %	100 Hz
Pulse Duration	0.5, 1.0, 2.0. 3.0, 4.0 and 5 ms (±10 %)	1 msec, 2 msec, 5 msec (± 20 %)
Temporal Peak/ average intensity ratio	2:1 ± 20 % at 50 % Duty Cycle2.5 :1 ± 20 % at 40 % Duty Cycle3.3:1 ± 20 % at 30 % Duty Cycle5:1 ± 20 % at 20 % Duty Cycle10:1 ± 20 % at 10 % Duty Cycle20:1 ± 20 % at 5 % Duty Cycle	2:1 ± 20 % at 50 % Duty Cycle5:1 ± 20 % at 20 % Duty Cycle9:1 ± 20 % at 10 % Duty Cycle
Maximum output power	N/A12 W for ME 94011.8 W for ME 9402	20 W for 10 cm² at 1 Mhz only10 W for 5 cm² at 1 and 3.3 Mhz2 W for 1 cm² at 3.3 Mhz only
Maximum intensity	2 W/cm² for continuous mode3 W/cm² for pulsed mode	2.5 W/cm² for continuous mode3 W/cm² for pulsed mode
Indication accuracy	± 20 %	± 20 %

Ultrasonic Applicator Specifications

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

244-4-4-4	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
9- - - -1A---------1

{14}------------------------------------------------

Frequency Effective Radiating Area Maximum Beam Non-Uniformity Ratio

1 MHz and 3 MHz ±5% 5.5 cm² (1 MHz) / 6.0 cm² (3 MHz) 4.55 : 1 maximum

5 cm² 1 MHz and 3.3 MHz ERA of 4 cm² for 5 cm² appl.

5:1 maximum

Applicator PartNumber	ME 9402
Frequency	1 MHz and 3 MHz	1 cm² at 3.3 MHz only
Effective	0.9 cm² (1MHz) / 0.9 cm² (3 MHz)	ERA is 0.8 cm² for 1 cm² appl.
Radiating Area
Maximum BeamNon-Uniformity Ratio	4.68 : 1 maximum	5:1 maximum
Other Applicators	None	10 cm² and 2 cm² applicators
Frequency	N/A	1 MHz and 3 MHz for 10 cm²applicator and3.3 MHz for 2 cm² applicatoronly
Effective RadiatingArea	N/A	ERA of 8.5 cm² for 10 cm²applicatorandERA of 1.8 cm² for 2 cm²applicator
Maximum BeamNon-Uniformity Ratio	N/A	5:1 maximum

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 1 2007

Robert F. Fleming Director. OA/RA Mettler Electronics Corp. 1333 South Claudina St. Anaheim, California 92805

Re: K071137

Trade/Device Name: Sonicator® Plus 940, Model ME 940 Regulation Number: 21 CFR 890.5860 Regulation Name: Ultrasound and muscle stimulator Regulatory Class: Class II Product Code: IMG, GZJ, LIH Dated: July 3, 2007 Received: July 9, 2007

Dear Mr. Fleming:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 - Mr. Robert F. Fleming

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

for

Mark N. Mellema, M.S. Ph.D.

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

Enclosure

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Enclosure 1

Attachment 1 b

Page_ of of of

510(k) Number (if known): _ K071137

Sonicator® Plus 940 (ME940) Device Name:

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
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

Increase local blood circulation 2.
Prevention or retardation of disuse atrophy 3.
1. Muscle re-education
న్న Maintaining or increasing range of motion
Immediate post surgical stimulation of calf muscles to prevent venous thrombosis 6.

DC (Direct Current)

Relaxation of muscle spasms

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

Concurrent of CDRH Office of Deville Bign (ODB) () iT)

Division of General, Restorative, and Neurological Devices

16071437

510(k) Number

Prescription Use V (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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.