(429 days)
ES-160, K051020
Not Found
No
The device description focuses on basic electrical stimulation parameters and controls, with no mention of AI or ML capabilities.
Yes
The device is described as providing "symptomatic relief of chronic intractable pain, postoperative pain, and acute pain," which are therapeutic benefits.
No
The intended use of the Neuro Wave 6 is for "symptomatic relief of chronic intractable pain, postoperative pain, and acute pain," which indicates a therapeutic purpose rather than a diagnostic one.
No
The device description explicitly details hardware components such as a battery-powered portable instrument, physical controls (ON/OFF switch, knobs), and specifications like weight, color, pulse shape, pulse rate, pulse width, output voltage, and power source (batteries). This indicates it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the symptomatic relief of pain. This is a therapeutic use, not a diagnostic one.
- Device Description: The description details a device that delivers electrical stimulation. This is consistent with a therapeutic device, not one used for in vitro testing of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes related to diagnosing conditions based on in vitro analysis.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. The Neuro Wave 6 is a therapeutic device that applies electrical stimulation to the body.
N/A
Intended Use / Indications for Use
The Neuro Wave 6 is intended for use in the symptomatic relief of chronic intractable pain, postoperative pain, and acute pain.
Product codes
GZJ
Device Description
The device consists of a battery powered portable instrument with 6 channel outputs.
Weight- 2.6 kg.
Color- Grey
Pulse Shape- Asymmetrical, Biphasic Triangular Wave
Pulse Rate- 1-100 Hz
Pulse Width-
Impedance Value: 500 ohms, Pulse Width: 280 uS
Impedance Value: 1000 ohms, Pulse Width: 240 US
Impedance Value: 2000 ohms, Pulse Width: 220 US
Impedance Value: 5000 ohms, Pulse Width: 220 uS
Impedance Value: 10000 ohms, Pulse Width: 220 uS
Output- 80 volts maximum (under 500 ohm test load)
Stimulation time- stimulation time is adjusted by the timer up to 60 minutes.
Device Controls- Clearly indicated are the ON/OFF (Power switch), Frequency Adjuster, Timer, and Output Intensity Knobs.
Power- 6 1.5 volt C batteries
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
prescription device and should be used under continued medical supervision.
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)
ES-160, K051020
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).
0
510(k) Summary
| Submitters information: Lhasa OMS, Inc. |
|---|
| 230 Libbey Parkway |
| Weymouth, MA 02189 |
SEP 1 9 2007
| Contact Person: Matthew Pike | Telephone: 781-340-1010 ext. 12 |
|---|---|
| Fax: 781-340-1637 |
Date Summary Prepared: April 16, 2007
| Device name: | |
|---|---|
| Proprietary name: | Neuro Wave 6 |
| Common or usual name: | Portable transcutaneous electrical nerve |
| stimulator (TENS) | |
| Classification name: | Transcutaneous electrical nerve stimulator, |
| Class II, 21 CFR 882.5890. |
Legally marketed device for substantial equivalence comparison: ES-160, K051020
Description of the device:
The device consists of a battery powered portable instrument with 6 channel outputs.
Weight- 2.6 kg.
Color- Grey
Pulse Shape- Asymmetrical, Biphasic Triangular Wave
Pulse Rate- 1-100 Hz
Pulse Width-
| Impedance Value
---------------------------------------- | 500 ohms | 1000 ohms | 2000 ohms | 5000 ohms | A MINI AN AN A A Commend Comments on The
10000 ohms |
|-------------------------------------------------------------|----------|-----------|-----------|-----------|--------------------------------------------------------|
| Pulse Width
A R R L B & L P | 280 uS | 240 US | 220 US | 220 uS | 220 uS |
Output- 80 volts maximum (under 500 ohm test load)
Stimulation time- stimulation time is adjusted by the timer up to 60 minutes.
Device Controls- Clearly indicated are the ON/OFF (Power switch), Frequency Adjuster, Timer, and Output Intensity Knobs.
Power- 6 1.5 volt C batteries
1
Intended use of the device:
The Neuro Wave 6 is intended for use in the symptomatic relief of chronic intractable pain, postoperative pain, and acute pain. This is a prescription device and should be used under continued medical supervision. The intended use of the ES-160 is identical.
The Neuro Wave 6 cannot be used transcerebrally, in the carotid sinus area or during pregnancy. Patients suspected of having heart disease should consider adequate precautionary measures prior to administration. Severe spasm of the laryngeal and pharyngeal muscles may occur when the electrode is placed across the neck or mouth. This may be enough to close off the airway. Stimulation will inhibit the output of some demand cardiac pacemakers and therefore, is not recommended for patients with this type of pacemaker. Electrical nerve stimulation is a symptomatic treatment, and as such may suppress the progress of pain which would otherwise serve as a protective influence on the outcome of a disease process. The potential for physical and/or psychological dependence upon nerve stimulation as a means of relieving pain has not been determined.
It has been noted that some patients find the sensation of electrical stimulation extremely unpleasant and should probably be excluded from further use of the stimulator.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Lhasa OMS, Inc. % Mr. Matthew Pike 230 Libbey Parkway Weymouth, MA 02189
SEP 1 9 2007
Re: K062003 Trade/Device Name: Neuro Wave 6 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZJ Dated: June 19, 2007 Received: June 21, 2007
Dear Mr. Pike:
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, Orug 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 not 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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 – Mr. Matthew Pike
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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sincerely yours,
Mark A Milkman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name: Neuro Wave 6
Indications for Use:
The Neuro Wave 6 is intended for use in the symptomatic relief of chronic intractable pain, postoperative pain, and acute pain.
Mark N. Mellem
(Division Sign-Off) Division of General. Restorative, and Neurological Levices
510(k) Number K062003
Prescription Use x AND/OR 21 CFR 810 Subpart D) (21 CFR 801 Subpart C)
Over-The-Counter Use (Part
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
G-1
Page 1 of 1