(99 days)
Not Found
No
The description focuses on standard therapeutic ultrasound and electrical stimulation modalities controlled by a microprocessor, with no mention of AI or ML capabilities.
Yes.
The device's intended use clearly lists therapeutic applications such as pain relief, reduction of muscle spasms, relief of joint contractures, and muscle re-education, indicating its role in treating medical conditions.
No
The device description and intended use indicate that it is a therapeutic device used for pain relief, muscle stimulation, and relaxation of muscle spasms. It does not mention any diagnostic functions.
No
The device description clearly describes a hardware device (Sonicator® Plus 940, Model ME 940) that provides therapeutic ultrasound and muscle stimulation through physical channels and applicators. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes therapeutic applications involving the application of physical energy (ultrasound and electrical stimulation) to the body for pain relief, muscle treatment, and improving range of motion. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a device that generates and delivers ultrasound and electrical stimulation waveforms. It focuses on the physical mechanisms of action and control of these energies.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
In summary, the Sonicator® Plus 940 is a therapeutic device used for physical therapy and pain management, not an in vitro diagnostic device.
N/A
Not Found
Intended Use / Indications for Use
Proposed Device Indications For Use (same as those for predicate device):
Therapeutic Ultrasound
-
- Pain relief
-
- Reduction of muscle spasm
-
- Localized increase in blood flow
-
- Increase range of motion of contracted joints using heat and stretch techniques.
Neuromuscular Stimulation
-
- Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain (Interferential and Pre-modulated waveforms)
-
- Temporary relaxation of muscle spasm (all waveforms)
-
- Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles (all waveforms)
-
- Increase of blood flow in the treatment area (all waveforms)
-
- Prevention or retardation of disuse atrophy in post-injury type conditions (all waveforms)
-
- Muscle re-education (all waveforms)
-
- Maintaining or increasing range of motion (all waveforms)
Indications for Use:
Therapeutic Ultrasound
Application of therapeutic deep heat for the treatment of selected sub-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
- · 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.
-
- Post-traumatic pain
-
- 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.
-
- 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
Product codes (comma separated list FDA assigned to the subject device)
IMG, GZJ, LIH
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
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
Not Found
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.
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
§ 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.
0
510(k) SUMMARY
SONICATOR® PLUS 940, ME 940, K (
AUG - 1 2007
)
1
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 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.
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
-
- Pain relief
-
- Reduction of muscle spasm
-
- Localized increase in blood flow
-
- Increase range of motion of contracted joints using heat and stretch techniques.
Neuromuscular Stimulation
-
- Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain (Interferential and Pre-modulated waveforms)
-
- Temporary relaxation of muscle spasm (all waveforms)
-
- Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles (all waveforms)
-
- Increase of blood flow in the treatment area (all waveforms)
-
- Prevention or retardation of disuse atrophy in post-injury type conditions (all waveforms)
-
- Muscle re-education (all waveforms)
-
- 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:
1
| 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 Current | |||
| Isolation | 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 Output | ||
| Modes | 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 / | ||
| Microprocessor | |||
| Control | Yes | Yes | |
| 9. | Automatic Overload | ||
| Trip | Yes | Not Stated in the Manual | |
| 10. | Automatic Over | ||
| Current Trip | Yes | Warning only, Overcurrent | |
| 11. | Automatic No Load | ||
| Trip | Yes | Warning only, Bad electrode contact | |
| 12. | Automatic Shut Off | Yes | Yes |
| 13. | Patient Override | ||
| Control Method | No | ||
| On/Off, Hold or Stop | Yes | ||
| Patient interrupt switch | |||
| 14. | Indicator Display | ||
| On / Off Status | Yes | Yes | |
| Voltage/Current | |||
| Level | Yes | Yes | |
| Low Battery | |||
| Indicator | 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 NO | |||
| 601.1-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 with | ||
| 21 CFR 898 | Yes | Yes | |
| 17. | Weight (lbs.) | 11 | 7 |
| 18. | Dimensions (in.) H x W | ||
| x 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 Name
Manufacturer | K
Sonicator Plus 940
Mettler Electronics | K031077
Vectra Genisys
Encore 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 Current
Density | | |
| (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 |
| Multiphasic | ||
| Waveforms............ | ||
| 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 Current | ||
| Density | ||
| (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 Name
Manufacturer | K
Sonicator Plus 940
Mettler Electronics | K031077
Vectra Genisys
Encore Medical
(Chattanooga Group) |
|----------------------------------------|------------------------------------------------|--------------------------------------------------------------------|
| Waveform | | |
| Continuous DC
Shape | 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 Name
Manufacturer | K
Sonicator Plus 940
Mettler Electronics | K031077
Vectra Genisys
Encore Medical
(Chattanooga Group) |
|----------------------------------------|------------------------------------------------|--------------------------------------------------------------------|
| Power Source | AC Line | AC Line |
| Standards
ISO 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 Treatment | ||
| Time: | 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 Cycle | |
| 2.5 :1 ± 20 % at 40 % Duty Cycle | ||
| 3.3:1 ± 20 % at 30 % Duty Cycle | ||
| 5:1 ± 20 % at 20 % Duty Cycle | ||
| 10:1 ± 20 % at 10 % Duty Cycle | ||
| 20:1 ± 20 % at 5 % Duty Cycle | 2:1 ± 20 % at 50 % Duty Cycle | |
| 5:1 ± 20 % at 20 % Duty Cycle | ||
| 9:1 ± 20 % at 10 % Duty Cycle | ||
| Maximum output power | N/A | |
| 12 W for ME 9401 | ||
| 1.8 W for ME 9402 | 20 W for 10 cm² at 1 Mhz only | |
| 10 W for 5 cm² at 1 and 3.3 Mhz | ||
| 2 W for 1 cm² at 3.3 Mhz only | ||
| Maximum intensity | 2 W/cm² for continuous mode | |
| 3 W/cm² for pulsed mode | 2.5 W/cm² for continuous mode | |
| 3 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 |
|
2
44-4-4-4
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 9
1
A
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 Part
| Number | 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 Beam | ||
| Non- | ||
| 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 cm² |
| applicator and | ||
| 3.3 MHz for 2 cm² applicator | ||
| only | ||
| Effective Radiating | ||
| Area | N/A | ERA of 8.5 cm² for 10 cm² |
| applicator | ||
| and | ||
| ERA of 1.8 cm² for 2 cm² | ||
| applicator | ||
| Maximum Beam | ||
| Non- | ||
| Uniformity Ratio | N/A | 5:1 maximum |
15
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
16
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
17
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;
-
- 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 1.
-
- Post-traumatic pain
-
- 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.
-
- 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)
OR
Over-The-Counter Use
(Optional Format 1-2-96)