(157 days)
No
The description details a standard powered nerve stimulator with no mention of AI or ML capabilities.
Yes
The device is intended for the temporary relief of pain associated with sore and aching muscles, which is a therapeutic purpose.
No
Explanation: The device description states its intended use is for "Temporary relief of pain associated with sore and aching muscles," and it is described as a "dual channeled powered nerve stimulator." These functions are therapeutic, not diagnostic.
No
The device description explicitly states it comprises an electronic stimulatory module, skin electrodes, lead wires, a belt, and batteries, indicating it is a hardware device with electrical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the temporary relief of pain associated with sore and aching muscles in the lower back. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is described as a "powered nerve stimulator" that "electronically stimulates nerves." This is a physical intervention, not a test performed on biological samples to diagnose a condition.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, or tissue), detecting biomarkers, or providing diagnostic information about a disease or condition.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
Temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.
Product codes
GZJ, NUH
Device Description
The Rhythm Touch Q 2-Way is a dual channeled powered nerve stimulator. It electronically stimulates nerves. It comprises two main components, namely, an electronic stimulatory module which generates the required stimulation signals, and skin electrodes with lead wires.
The product is supplied with two sets of electrodes, a belt to fix and hold the unit and the electrodes, an instruction manual, and a set of batteries. Power is derived from two AAA cells located in a compartment protected by a removable battery cover.
The electrodes provided with this model have 510(k) clearance. They are rectangular, 1.5"x1.75" in size. The lead wires also have 510(k) clearance.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower back
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)
BIOSTIM KIT, K050174
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
MAY 2 4 2007
510(k) Summary
....
:
:
| Date prepared: | 14 December 2006 / revised 2 April 2007 |
|---|---|
| Applicant: | Shockim Enterprise Ltd. |
| 2500 Wilshire Boulevard, Suite 1115 | |
| Los Angeles, CA 90057 | |
| Contact person: | Nicolaas C. Besseling, Consultant |
| BesTech Consulting Services | |
| 28711 Jaeger Drive | |
| Laguna Niguel, CA 92677 | |
| 949.466.7472 | |
| bestechconsulting@cox.net | |
| Trade name: | Rhythm Touch Q 2-Way |
| Common name: | Stimulator, nerve, transcutaneous, |
| for pain relief | |
| Classification name: | Transcutaneous electrical nerve |
| stimulator for pain relief | |
| Predicate device: | BIOSTIM KIT, K050174 |
| Class: 2 | |
| Product GZJ, | |
| codes: NUH | |
| Device description: | The Rhythm Touch Q 2-Way is a dual channeled powered |
| nerve stimulator. It electronically stimulates nerves. It com- | |
| prises two main components, namely, an electronic stimula- | |
| tory module which generates the required stimulation sig- | |
| nals, and skin electrodes with lead wires. |
The product is supplied with two sets of electrodes, a belt to
fix and hold the unit and the electrodes, an instruction man-
ual, and a set of batteries. Power is derived from two AAA
cells located in a compartment protected by a removable
battery cover.
The electrodes provided with this model have 510(k) clear-
ance. They are rectangular, 1.5"x1.75" in size. The lead
wires also have 510(k) clearance. |
| Intended use: | Temporary relief of pain associated with sore and aching
muscles in the lower back due to strain from exercise or
normal household and work activities. |
| Summary of the technological
characteristics of our device
compared to the predicate
device: | The Rhythm Touch Q 2-Way and the predicate device have
similar technological characteristics. The Rhythm Touch Q
2-Way does not pose any new or different safety hazards,
and the devices are substantially equivalent. |
1
Public Health Service
Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight. The symbol is composed of three stylized lines that form the wings and body of the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 4 2007
Shockim Enterprise Ltd. % BesTech Consulting Services Mr. Nicolaas C. Besseling Consultant 2500 Wilshire Boulevard, Suite 1115 Los Angeles, California 90057
RE: K063743
Trade/Device Name: Rhythm Touch Q 2-Way Regulation Number: 21 CFR 888.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: NUH Dated: April 3, 2007 Received: April 9, 2007
Dear Mr. Besseling:
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 for abo stated in the 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 toat FDA has made a determination that your device complies with other requirements of the Act that I Dr I had Intatutes and regulations administered by other Federal agencies. You must or uny vith 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
2
Page 2 - Mr. Michael Kvitnitsky
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.
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html
Sincerely yours,
Mark A. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for use
510(k) number (if known:
Rhythm Touch Q 2-Way
Device name:
Indications for use:
Temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.
Over-The-Counter use and/or Prescription use ﮯ (Part 21 CFR 801 Subpart D) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Mark A. Millhuser
(Division Sign-Off) (Division Sugaronal, Restorative, and Neurological Devices
510(k) Number
510(k) Number