(93 days)
Interferential stimulation can be used for the following applications:
- Relieve acute pain .
- . Relieve and manage chronic pain
- Relax muscle spasms .
- Maintain and increase the range of motion .
- Increase local blood circulation .
Neuromuscular stimulation can be used for the following applications:
- Relax muscle spasms .
- Prevent or retard disuse atrophy .
- Increase local blood circulation .
- Re-educate muscles .
- Maintain or increase the range of motion .
- Prevent venous thrombosis using immediate postsurgical stimulation on calf . muscles
Pulsed direct current stimulation can be used for the following applications:
- Reduction of edema (under negative electrode) t
- Reduction of muscle spasm .
- Influencing local blood circulation (under negative electrode) .
- Retardation or prevention of disuse atrophy .
- Facilitation of voluntary motor function .
- Maintenance or increase of range of motion .
Interferential and Neuromuscular combination stimulation can be used for the following applications:
- Reduction of edema (under negative electrode) .
- Reduction of muscle spasm .
The IF 3 Wave is a non-invasive medium/low frequency interferential muscle rie it -> wave is a intended for treating patients that have acute and chronic pain, edema, tight musculature, muscle spasms and muscular weakness due to disuse atrophy. The IF 3 Wave stimulator is a microprocessor controlled dual channel Interferential electro-stimulator with neuro-muscular and pulse direct current micronital expabilities. It will offer 4 separate electro-therapy stimulation modalities. Stimulation capacificies: 17 Will on P), neuromuscular electrical stimulation (NMES), r neso direct current (PDC) electrical stimulation, and a combination of interferential and neuromuscular electrical stimulation (IF/NMES).
The IF 3 Wave will be capable of storing device settings, use, and compliance data for up to 90 days. It will be capable of down loading the above compliance date through a up to 90 days. which is contained within the battery charger base. Once per phone mic modelin, will be instructed to download the stored data from their device, month, the patient will over compliance report which is forwarded to their physicians for which will ereate a paysician will review the report and provide adjustment to the patient treatment regimen and device setting accordingly.
Accessories provided with the IF 3 Wave include lead wires, electrode pads, Accessories proTracu wik, battery charger/modem, phone cable, power supply, and a users manual.
This K510(k) submission describes the IF 3Wave Interferential Muscle Stimulator System, Model 7110S. The submission focuses on establishing substantial equivalence to previously cleared predicate devices rather than reporting on a new clinical study with acceptance criteria.
Therefore, many of the requested sections related to acceptance criteria and study data are not applicable to this 510(k) submission.
Here's an analysis based on the provided text, addressing the applicable points:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a 510(k) summary demonstrating substantial equivalence, there are no explicit "acceptance criteria" in the sense of predefined thresholds for clinical or diagnostic performance metrics. Instead, the device's technical characteristics are compared to those of its predicate devices to demonstrate equivalence. The "reported device performance" is essentially the listed technical specifications of the IF 3Wave.
| Characteristic | Predicate Device (IF-II Model 7100S) | IF 3Wave (Model 7110S) | Predicate Device (EMS+2 Model 6840S) | IF 3Wave (Model 7110S) | Predicate Device (SporTX Model 7700S) | IF 3Wave (Model 7110S) |
|---|---|---|---|---|---|---|
| Interferential Modality | ||||||
| Patient Leakage Current (Normal) | Unknown | < 0.1 microamperes | Unknown | < 0.1 microamperes | Unknown | < 0.1 microamperes |
| Patient Leakage Current (Single Fault) | Unknown | 2.4 microamperes | Unknown | 2.4 microamperes | Unknown | 2.4 microamperes |
| Output Modes | 1 | 3 | 1 | 3 | 1 | 3 |
| Automatic Overload Trip | No | Yes, 5 kohms | No | Same | No | Same |
| Continuous Treatment Time Selection | 20 minutes, fixed | 10 - 60 min, selectable (5 min steps) | 15, 30, or 60 min, or Continuous, selectable | 10 - 60 min, selectable (5 min increments) | 38 min or Continuous, selectable | 30 - 60 min, selectable (5 min increments) |
| Number of Variable Sweep Programs | 3 | 4 | N/A | N/A | N/A | N/A |
| Number of Fixed Parameter Sweep Programs | 0 | 7 | N/A | N/A | N/A | N/A |
| Max Charge per Pulse | 120 microcoulombs | Same | 30 microcoulombs | Same | 6 microcoulombs | Same |
| Average DC Current | N/A | N/A | N/A | N/A | 266 microamperes | 300 microamperes |
| Compliance with Voluntary Standards | Unknown | Yes | Unknown | Yes | Unknown | Yes |
| NMES Modality | (see above) | |||||
| Output Modes | N/A | N/A | 1 | 3 | N/A | N/A |
| Pulse Width | N/A | N/A | 50 - 300 us, adjustable | 70 - 300 us (10 us steps) | N/A | N/A |
| Pulse Frequency | N/A | N/A | 4 - 80 Hz, adjustable | 10 – 80 Hz (5 Hz steps) | N/A | N/A |
| Pulse Amplitude | N/A | N/A | 0 – 100 mA (1000 Ohm load), adjustable | 0 - 100 mA (1000 Ohm load) (1 mA steps) | N/A | N/A |
| Cycle ON Time | N/A | N/A | 0.5 - 30 seconds, adjustable | 1 - 30 seconds (1 second increments) | N/A | N/A |
| Cycle OFF Time | N/A | N/A | 0.1 - 60 seconds, adjustable | 1 - 60 seconds (1 second increments) | N/A | N/A |
| Ramp-Up Time | N/A | N/A | 0.1 - 6, adjustable | 0 - 10 seconds (1 second increments) | N/A | N/A |
| Ramp-Down Time | N/A | N/A | 0.1 - 6 seconds, adjustable | 0 - 10 seconds (0.5 second increments) | N/A | N/A |
| PDC Modality | (see above) | |||||
| Output Modes | N/A | N/A | N/A | N/A | 1 | 3 |
| Number of Preset Programs | N/A | N/A | N/A | N/A | 0 | 3 |
| Pulse Width (Biphasic/Triphasic) | N/A | N/A | N/A | N/A | Biphasic: 60 us / Triphasic: 60 us | Same |
| Pulse Frequency (Biphasic/Triphasic) | N/A | N/A | N/A | N/A | Biphasic: 278 Hz / Triphasic: 222 Hz | Same |
| Pulse Amplitude | N/A | N/A | N/A | N/A | 0 - 100 mA (1000 Ohm Load), adjustable | 0 - 100 mA (1000 Ohm Load) (1 mA increments) |
Note: "Same" in the table indicates that the characteristic matches the predicate device. "N/A" means the characteristic is not applicable to that specific modality for the predicate device as presented in the provided text.
The rationale for substantial equivalence is that the differences in the IF 3Wave (e.g., three output modes instead of one, automatic overload trip, wider range of treatment times and programming options, compliance with voluntary standards, lithium-ion battery) do not raise new questions of safety or effectiveness.
2. Sample Size for the Test Set and Data Provenance:
Not applicable. This is a 510(k) submission based on substantial equivalence to predicate devices, focusing on technical specifications and indications for use, not a clinical study with a "test set" of patients.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. No ground truth for a test set was established as no clinical study was performed for this 510(k) submission.
4. Adjudication Method for the Test Set:
Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. No MRMC study was conducted. This type of study demonstrates the clinical utility and impact of AI, which is not relevant for a device cleared through substantial equivalence to existing stimulators.
6. Standalone (Algorithm Only) Performance:
Not applicable. This device is a powered muscle stimulator, not an AI algorithm. Its performance is evaluated based on its physical and electrical characteristics and comparison to predicate devices, not on algorithmic outputs.
7. Type of Ground Truth Used:
Not applicable. Instead of "ground truth," the basis for equivalence is the well-established safety and effectiveness of the predicate muscle stimulator devices. The "truth" is that these types of devices are already legally marketed and have known performance characteristics.
8. Sample Size for the Training Set:
Not applicable. There is no AI model or algorithm being trained as part of this submission. The device itself is a hardware product.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
{0}------------------------------------------------
KC50046
APR 1 3 2005
Summary of Safety and Effectiveness:
Summary of Safety and Effectiveness
Applicant Information
Compex Technologies, Inc. 1811 Old Highway 8 New Brighton, MN 55112 Phone: (612) 638-0590 (612) 638-0479 FAX:
Contact Person
Brian J. Edwards, M.S. Director of Regulatory Affairs & Quality Assurance
Date Summary Prepared
September 1, 2004
Device identification
| Trade / Proprietary Name: | IF 3Wave Interferential Muscle Stimulator System,Model 7110S |
|---|---|
| Common / Usual Name: | Muscle and Interferential Current |
| Classification Name: | 21 CFR 890.5850 "Powered Muscle Stimulator" |
| Product Classification: | Class II |
| Product Code: | IPF |
{1}------------------------------------------------
Legally Market Predicate Devices
| Predicate Device | 510(k) Number / Clearance Date |
|---|---|
| Staodyne, Inc. EMS+2 NeuromuscularStimulation System | K926510 / August 11, 1993 |
| Medical Devices, Inc. Model IF-IIInterferential Stimulation System | K923914 / November 6, 1992 |
| Staodyne, Inc. Model SporTX PulsedDirect Current and TENS Stimulator | K921668 / August 3, 1992 |
| Axelgaard Manufacturing CompanyTENS Pals Plus Electrodes | K872976 / September 22, 1987 |
| Axelgaard Manufacturing CompanyValutrode Electrodes | K970426 / May 9, 1997 |
The IF 3Wave Interferential Stimulator System, Model 7110S is comparable in type and function and are substantially equivalent to the following predicate devices.
Device Description
The IF 3 Wave is a non-invasive medium/low frequency interferential muscle rie it -> wave is a intended for treating patients that have acute and chronic pain, edema, tight musculature, muscle spasms and muscular weakness due to disuse atrophy. The IF 3 Wave stimulator is a microprocessor controlled dual channel Interferential electro-stimulator with neuro-muscular and pulse direct current micronital expabilities. It will offer 4 separate electro-therapy stimulation modalities. Stimulation capacificies: 17 Will on P), neuromuscular electrical stimulation (NMES), r neso direct current (PDC) electrical stimulation, and a combination of interferential and neuromuscular electrical stimulation (IF/NMES).
The IF 3 Wave will be capable of storing device settings, use, and compliance data for up to 90 days. It will be capable of down loading the above compliance date through a up to 90 days. which is contained within the battery charger base. Once per phone mic modelin, will be instructed to download the stored data from their device, month, the patient will over compliance report which is forwarded to their physicians for which will ereate a paysician will review the report and provide adjustment to the patient treatment regimen and device setting accordingly.
Accessories provided with the IF 3 Wave include lead wires, electrode pads, Accessories proTracu wik, battery charger/modem, phone cable, power supply, and a users manual.
{2}------------------------------------------------
Technical Characteristics
The IF functional mode of the IF 3Wave is substantially equivalent to the functional mode of the Rehabilicare IF-II device.
| Interferential Modality. | ||
|---|---|---|
| IF-IIModel 7100S | IF 3WaveModel 7110S | |
| 510(k) Number | K923914 | |
| Manufacturer | Medical Devices, Inc. | Compex Technologies, Inc. |
| Power Source | 4 AA rechargeable batteriesLine Powered Repack | Lithium ion polymer rechargeablebattery. |
| Weight | 12 oz, with battery | 12 oz, with battery |
| Dimensions | 3.2 x 5.2 x 1.15 in. | 3.89 x 6.33 x 1.42 in |
| Case Materials | ABS/PC Blend | Same |
| Patient Leakage Current* | ||
| Normal | Unknown | < 0.1 microamperes |
| Single Fault | Unknown | 2.4 microamperes |
| Output Modes | 1 | 3 |
| Number of OutputChannels | 2 | Same |
| Method of ChannelIsolation | Transformer isolation | Same |
| Regulated Current orVoltage | Voltage | Same |
| Software, Firmware,Microprocessor Controlled | Yes | Same |
| Automatic Overload Trip | No | Yes, 5 kohms |
| Automatic No-Load Trip | Yes | Same |
| Automatic Shut-off | Yes | Same |
| Patient Override Controls | Yes | Same |
| Indicator DisplayOn/Off Status | Yes | Same |
| Low Battery | Yes | Same |
| Voltage, Current Level | Yes | Same |
| Waveform | Symmetrical biphasic squarewave with 0 net DC | Same |
| Pulse Width | 125 microseconds | Same |
| Carrier Pulse Frequency(Channel 1) | 4000 Hz, fixed | Same |
| Adjustable PulseFrequency(Channel 2) | 4001 — 4150 Hz | Same |
| Interferential BeatFrequency | 1 - 150 Hz | Same |
| Pulse Amplitude | 0 - 50 mA, adjustable in 1 mAsteps into 500 ohm load | Same |
{3}------------------------------------------------
| Indications for Use | Relieve acute painRelieve and manage chronicpainRelax muscle spasmsMaintain and increase the rangeof motionIncrease local blood circulation | Same |
|---|---|---|
| Number of ContinuousTreatments | 1 | Same |
| Continuous TreatmentTime Selection | 20 minutes, fixed | 10 - 60 minutes, selectable in 5minute steps |
| Number of Variable SweepPrograms | 3 | 4 |
| Sweep Treatment TimeSelection | 20 minutes, fixed | 10 - 60 minutes, selectable in 5minute steps |
| Sweep Program CycleTimes | 1 sec Up / 1 sec Down6 sec Up / 6 sec Down | 6 sec Up / 6 sec Down12 sec Up / 12 sec Down24 sec Up / 24 sec Down |
| Number of FixedParameter SweepPrograms | 0 | 7 |
| Sweep Program FrequencyRange | 1 - 150 Hz, selectablecontinuously using a rheostat | 1 - 150 Hz, selectable in 1 Hz steps |
| Maximum Charge perPulse | 120 microcoulombs | Same |
| Maximum Output Voltage | 50 volts, peak-to-peak, 500 ohmload | Same |
| Peak Output Current | 100 mA, peak-to-peak, 500ohm load | Same |
| Net Charge per Pulse | 0 microcoulombs, biphasicwaveform | Same |
| Max Phase Charge | 6.25 microcoulombs | Same |
| Max Current Density# | 1.937 mA / cm2 (average) | Same |
| Max Power Density# | 0.097 W/cm2 (average) | Same |
| Burst Modes | N/A | N/A |
| Compliance with VoluntaryStandards | Unknown | Yes, refer to page 43 of thesubmission for list |
| NMES Modality. | ||
| EMS+2Model 6840S | IF 3WaveModel 7110S | |
| 510(k) Number | K926510 | |
| Manufacturer | Staodyne, Inc. | Compex Technologies, Inc. |
| Power Source | 9 volt battery - alkaline or nickelmetal hydride rechargeable | Lithium ion polymerrechargeable battery. |
| Weight | 7.97 oz, with battery | 12 oz, with battery |
| Dimensions | 5.4 x 3.2 x 1.2 in. | 3.89 x 6.33 x 1.42 in |
| Case Materials | ABS/PC Blend | Same |
| Waveform | Symmetrical biphasic with zeronet DC component | Same |
| Patient Leakage Current* | ||
| Normal | Unknown | < 0.1 microamperes |
| Single Fault | Unknown | 2.4 microamperes |
| Output Modes | 1 | 3 |
| Number of Output Channels | 2 | Same |
| Method of Channel Isolation | N/A | Same |
| Regulated Current or Voltage | Current | Same |
| Software, Firmware,Microprocessor Controlled | Yes | Same |
| Automatic Overload Trip | No | Same |
| Automatic No-Load Trip | Yes | Same |
| Automatic Shut-off | Yes | Same |
| Patient Override Controls | Yes | Same |
| Indicator Display | ||
| On/Off Status | Yes | Same |
| Low Battery | Yes | Same |
| Voltage, Current Level | Yes | Same |
| Number of Preset Programs | 0 | 6 |
| Pulse Width | 50 - 300 microseconds, adjustable | 70 - 300 microseconds in 10microsecond steps |
| Pulse Frequency | 4 - 80 Hz, adjustable | 10 – 80 Hz in 5 Hz steps |
| Pulse Amplitude | 0 – 100 mA across a 1000 Ohmload, adjustable | 0 - 100 mA in 1 mA stepsacross a 1000 Ohm load |
| Indications for Use | Relax muscle spasmsPrevent or retard disuse atrophyIncrease local blood circulationRe-educate musclesMaintain or increase the range ofmotion | Same |
| Prevent venous thrombosis usingimmediate postsurgical stimulationon calf muscles | ||
| Treatment Time Selection | 15, 30, or 60 minutes, orContinuous, selectable | 10 - 60 minutes, in 5 minuteincrements |
| Cycle ON Time | 0.5 - 30 seconds, adjustable | 1 - 30 seconds, in 1 secondincrements |
| Cycle OFF Time | 0.1 - 60 seconds, adjustable | 1 - 60 seconds, in 1 secondincrements |
| Ramp-Up Time | 0.1 - 6, adjustable | 0 -10 seconds, in 1 secondincrements |
| Ramp-Down Time | 0.1 - 6 seconds, adjustable | 0 - 10 seconds, in 0.5 secondincrements |
| Maximum Output Voltage | 100 volts, 0-to-peak, 1000 ohmload | Same |
| Peak Output Current | 100 mA, 0 -to-peak, 1000 ohmload | Same |
| Maximum Charge per Pulse | 30 microcoulombs | Same |
| Net Charge per Pulse | 0 microcoulombs, biphasicwaveform | Same |
| Max Phase Charge | 30 microcoulombs | Same |
| Max Current Density# | 0.19 mA/cm2 (average) | Same |
| Max Power Density# | 0.019 W/cm2 (average) | Same |
| Burst Modes | N/A | N/A |
| Compliance with VoluntaryStandards | Unknown | Yes, refer to page 43 of thesubmission for list |
| PDC Modality. | ||
| SporTXModel 7700S | IF 3WaveModel 7110S | |
| 510(k) Number | K921668 | |
| Manufacturer | Staodyne, Inc. | Compex Technologies, Inc. |
| Power Source | 9 volt alkaline or rechargeablebattery | Lithium ion polymerrechargeable battery. |
| Weight | 4.4 oz, with battery | 12 oz, with battery |
| Dimensions | 2.1 x 4.2 x 0.9 in | 3.89 x 6.33 x 1.42 in |
| Case Materials | ABS/PC Blend | Same |
| Patient Leakage Current* | ||
| Normal | Unknown | < 0.1 microamperes |
| Single Fault | Unknown | 2.4 microamperes |
| Output Modes | 1 | 3 |
| Number of Output Channels | 2 | Same |
| Method of Channel Isolation | N/A | Same |
| Regulated Current orVoltage | Current | Same |
| Software, Firmware,Microprocessor Controlled | Yes | Same |
| Automatic Overload Trip | No | Same |
| Automatic No-Load Trip | Yes | Same |
| Automatic Shut-off | Yes | Same |
| Patient Override Controls | Yes | Same |
| Indicator Display | ||
| On/Off Status | Yes | Same |
| Low Battery | Yes | Same |
| Voltage, Current Level | Yes | Same |
| Waveform 1 | Symmetrical biphasic squarewavewith zero net DC | Same |
| Waveform 2 | Unbalanced Triphasic withpositive net DC | Same |
| Number of Preset Programs | 0 | 3 |
| Pulse Width | Biphasic: 60 microsecondsTriphasic: 60 microseconds | Same |
| Pulse Frequency | Biphasic: 278 HzTriphasic: 222 Hz | Same |
| Pulse Amplitude | 0 - 100 mA across a 1000 OhmLoad, adjustable | 0 - 100 mA in 1 mAincrements across a 1000Ohm load |
| Indications for Use | Reduction of edema (undernegative electrode) | Same |
| Reduction of muscle spasm | ||
| Influencing local blood circulation | ||
| Retardation or prevention ofdisuse atrophy | ||
| Facilitation of voluntary motorfunction | ||
| Maintenance or increase of rangeof motion | ||
| Treatment Time Selection | 38 minutes or Continuous,selectable | 30 - 60 minutes, in 5 minuteincrements |
| Maximum Output Voltage | 100 Volts, 100 ohm load | Same |
| Maximum Charge per Pulse | 6 microcoulombs | Same |
| Average DC Current | 266 microamperes | 300 microamperes |
| Net Charge per Pulse | 0 microcoulombs, biphasicwaveform | Same |
| Max Phase Charge | 60 microcoulombs per pulse | Same |
| Max Current Density# | 0.13 mA/cm² (average) | Same |
| Max Power Density# | 0.013 W/cm² (average) | Same |
| Burst Modes | N/A | N/A |
| Compliance with VoluntaryStandards | Unknown | Yes, refer to page 43 of thesubmission for list |
*Patient Leakage Current was determined following test procedure within IEC 601-1
#These values were calculated using the average current over time, not pulse current, with a 500 ohm load.
{4}------------------------------------------------
The NMES functional mode of the IF 3Wave is substantially equivalent to the functional mode of the Rehabilicare EMS+2 device.
{5}------------------------------------------------
*Patient Leakage Current was determined following test procedure within IEC 601-1
#These values were calculated using the average current over time, not pulse current, with a 500 ohm load.
{6}------------------------------------------------
The PDC functional mode of the IF 3Wave is substantially equivalent to the functional mode of the Rehabilicare SporTX device.
{7}------------------------------------------------
*Patient Leakage Current was determined following test procedure within IEC 601-1
#These values were calculated using the average current over time, not pulse current, with a 500 ohm load.
{8}------------------------------------------------
Indications for use
The IF 3Wave Interferential Stimulator System is intended for:
Interferential stimulation can be used for the following applications:
- Relieve acute pain .
- . Relieve and manage chronic pain
- Relax muscle spasms .
- Maintain and increase the range of motion .
- Increase local blood circulation .
Neuromuscular stimulation can be used for the following applications:
- Relax muscle spasms .
- Prevent or retard disuse atrophy .
- Increase local blood circulation .
- Re-educate muscles .
- Maintain or increase the range of motion .
- Prevent venous thrombosis using immediate postsurgical stimulation on calf . muscles
Pulsed direct current stimulation can be used for the following applications:
- Reduction of edema (under negative electrode) t
- Reduction of muscle spasm .
- Influencing local blood circulation (under negative electrode) .
- Retardation or prevention of disuse atrophy .
- Facilitation of voluntary motor function .
- Maintenance or increase of range of motion .
Interferential and Neuromuscular combination stimulation can be used for the following applications:
- Reduction of edema (under negative electrode) .
- Reduction of muscle spasm .
{9}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/9/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle.
APR 1 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Compex Technologies, Inc. c/o Mr. Daniel Lehtonen Intertek Testing Services 70 Codman Hill Road Boxborough, Massachusetts 01719
Re: K050046
Trade/Device Name: IF 3 Wave Interferential Muscle Stimulator System, Model 7110S Regulation Numbers: 21 CFR 890.5850, 21 CFR 882.5890 Regulation Name: Powered muscle stimulator, Transcutaneous electrical nerve stimulator for pain relief and Interferential current therapy Regulatory Class: II Product Codes: GZJ, IPF and LIH Dated: March 28, 2005 Received: March 29, 2005
Dear Mr. Lehtonen:
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 r reaso or admised 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 or any I 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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{10}------------------------------------------------
Page 2 - Mr. Daniel Lehtonen
This letter will allow you to begin marketing your device as described in your Section 510(k) This icher will anow you to begin mailing of substantial equivalence of your device to a legally premailed 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 If you desire specific at no 101-11-1120. Also, please note the regulation entitled, Colliact the Office of Compilance in (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Renele K
Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{11}------------------------------------------------
050046 510(k) Number (if knowm):
Device Name
Compex Technologies IF 3Wave Interferential Stimulator System, Model 7110S.
Indications for Use
Interferential stimulation can be used for the following applications:
- Relieve acute pain .
- Relieve and manage chronic pain .
- Relax muscle spasms ●
- Maintain and increase the range of motion .
- Increase local blood circulation .
Neuromuscular stimulation can be used for the following applications:
- . Relax muscle spasms
- Prevent or retard disuse atrophy .
- Increase local blood circulation .
- Re-educate muscles .
- Maintain or increase the range of motion .
- Prevent venous thrombosis using immediate postsurgical stimulation on calf . muscles
Pulsed direct current stimulation can be used for the following applications:
- Reduction of edema (under negative electrode) .
- Reduction of muscle spasm .
- Influencing local blood circulation (under negative electrode) .
- Retardation or prevention of disuse atrophy .
- Facilitation of voluntary motor function .
- Maintenance or increase of range of motion .
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Restorative
Ko50046
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).