(22 days)
Not Found
No
The device description focuses on traditional microprocessor control, waveforms, and user interface elements, with no mention of AI or ML capabilities.
Yes
The device is used for pain relief, muscle spasm reduction, and other therapeutic indications, consistent with a therapeutic device.
No
This device is described as a two-channel combination unit for therapeutic ultrasound and muscle stimulation, primarily used for pain relief, muscle spasm reduction, increased blood flow, and muscle re-education. Its indications for use are focused on therapeutic outcomes rather than diagnosing conditions.
No
The device description clearly outlines hardware components such as a two-channel combination unit, microprocessor control, membrane panel, LED displays, and control knobs, indicating it is a physical medical device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The indications for use clearly describe therapeutic applications involving the body (pain relief, muscle spasm reduction, blood flow increase, range of motion improvement, etc.). These are not diagnostic tests performed on samples taken from the body.
- Device Description: The device description details a therapeutic ultrasound and neuromuscular stimulation unit. It describes how it delivers energy to the body for treatment purposes.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition based on in vitro analysis.
The device is a therapeutic medical device used for physical therapy and pain management.
N/A
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)
Product codes (comma separated list FDA assigned to the subject device)
IMI, IPF, GZJ, LIH
Device Description
The Sonicator Plus 930 is a two-channel combination unit for therapeutic ultrasound and muscle stimulation. The microprocessor controlled Sonicator Plus 930 provides pre-modulated medium frequency and symmetrical biphasic waveforms with enhanced reliability and ease of use. In addition the Sonicator Plus 930 offers 1 and 3 MHz ultrasound using a variety of interchangeable applicators.
The two-channel Sonicator Plus 930 allows the clinician to utilize up to two different waveforms using two 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 pre-modulated 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. The new Treatment Status Indicator shows the operator which stimulation waveform has been chosen for treatment. The status display moves when treatment output is active.
Large, soft-touch control knobs make adjusting power for ultrasound and stimulation easy to accomplish with no guesswork involved. Two LED output displays allow the clinician to monitor two channels simultaneously for two channel combination treatment protocols. These also allow the operator to adjust both channels of an interferential protocol simultaneously while monitoring the current.
The Sonicator Plus 930 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
§ 890.5300 Ultrasonic diathermy.
(a)
Ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. An ultrasonic diathermy 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.(2)
Classification. Class II (performance standards).(b)
Ultrasonic diathermy for all other uses —(1)Identification. An ultrasonic diathermy 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 that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues 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 ultrasonic diathermy 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 ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasonic diathermy 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
OCT 1 7 2001
Mettler Electronics Corp. Submitter's Name: 1333 South Claudina Street Address: Anaheim, CA 92805
Telephone: 714-533-2221
Robert E. Fleming Contact: Director of Operations
Date Prepared: October 1, 2001
Proposed Device Name:
- a. TRADE NAME: Sonicator® Plus 930, Model ME 930
- b. CLASSIFICATION NAME: Ultrasound and Muscle Stimulator
- c. COMMON NAME: Combination ultrasound and Muscle Stimulator
Predicate Device:
- a. TRADE NAME: Sonicator® Plus 992, Model ME 992
- b. 510(k) Number: K984142
Description of Proposed Device:
The Sonicator Plus 930 is a two-channel combination unit for therapeutic ultrasound and muscle stimulation. The microprocessor controlled Sonicator Plus 930 provides pre-modulated medium frequency and symmetrical biphasic waveforms with enhanced reliability and ease of use. In addition the Sonicator Plus 930 offers 1 and 3 MHz ultrasound using a variety of interchangeable applicators.
The two-channel Sonicator Plus 930 allows the clinician to utilize up to two different waveforms using two 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 pre-modulated 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. The new Treatment Status Indicator shows the operator which stimulation waveform has been chosen for treatment. The status display moves when treatment output is active.
1
Large, soft-touch control knobs make adjusting power for ultrasound and stimulation easy to accomplish with no guesswork involved. Two LED output displays allow the clinician to monitor two channels simultaneously for two channel combination treatment protocols. These also allow the operator to adjust both channels of an interferential protocol simultaneously while monitoring the current.
The Sonicator Plus 930 can provide electrical stimulation only, ultrasound only and combination therapy with the pre-modulated, biphasic and medium frequency waveforms
Proposed Device Intended Use Statement:
510(k) Number: K013192
Device Name: Sonicator® Plus 930, Model ME 930
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)
2
Comparison of Technological Characteristics Between Proposed and Predicate Devices:
| 510 K #
Device Name
Manufacturer | K013192
Sonicator Plus
930
Mettler
Electronics | K984142
Sonicator Plus
992
Mettler
Electronics |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Power Source | AC Line | AC Line |
| Number of output
modes | 4 | 6 |
| Channel(s) | 2 | 2 |
| Synchronous | 1 & 2 | 1 & 2 |
| Reciprocal | 1 & 2 | 1 & 2 |
| Other | Yes | Yes |
| Computerized | No | No |
| Software provided | N/A | N/A |
| Constant current | Yes | Yes |
| Constant voltage | No | No |
| Max output current
(mA) | 0-65 ±10% mA RMS, max.,
1 Kohm load, Interferential
mode
0-50 ±10% mA RMS, max.,
1 Kohm load, premodulated
mode | 0-65 ±10% mA RMS, max.,
1 Kohm load, Interferential
mode
0-50 ±10% mA RMS, max.,
1 Kohm load, premodulated
mode
10-990 ±10 μA peak,
1 Kohm load, microamp
mode |
| Max output voltage (V) | 0-65 ±10% volts RMS, 1
Kohm load, Interferential
mode
0-50 ±10% volts RMS
premodulated mode | 0-65 ±10% volts RMS, 1
Kohm load, Interferential
mode
0-50 ±10% volts RMS
premodulated mode
1.0 ±10% volt peak, 1 Kohm
load, microcurrent mode |
| Waveforms &
Channels | | |
| All Channels | Premodulated | Premodulated |
| Channel 1 & 2 | Interferential | Interferential |
| Channel 1 | Combination Therapy and
all others | High Volt and Combination
Therapy and all others
except microcurrent |
| Channel 2 | All | Microcurrent and all others
except high volt |
| Output displays | Two simultaneously, amber
channel active indicators | Two simultaneously, amber
channel active indicators |
| Channel isolation | Yes | Yes |
| Line current isolation | Yes | Yes |
| Automatic overload
trip | Yes | Yes |
| Automatic over current
trip | Yes | Yes |
| Current/Voltage level | 70 mA RMS, interferential
mode
55 mA RMS, premodulated
mode | 70 mA RMS, interferential
mode
55 mA RMS, premodulated
mode
110 mA peak, microcurrent |
| Automatic no load trip | Yes | Yes |
| Patient override | None | None |
| control method | On/Off or Hold | On/Off or Hold |
| Max leakage current
(μΑ) | | |
| Chassis |