(119 days)
No
The summary describes a standard electrical stimulation device and does not mention any AI or ML components or functionalities.
Yes
The device is intended for "symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain," which are therapeutic applications.
No
The device is described as an Interferential Current Therapy Device used for symptomatic relief and management of pain, which indicates a therapeutic rather than a diagnostic function.
No
The device description explicitly states it generates electrical signals delivered through lead cables and electrode pads, indicating it includes hardware components beyond just software.
Based on the provided information, the INF 4160 PLUS is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the symptomatic relief and management of pain through electrical stimulation applied to the skin. This is a therapeutic application, not a diagnostic one.
- Device Description: The device generates electrical signals to stimulate nerves. This is a physical therapy modality, not a device that analyzes biological samples (which is the core function of an IVD).
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of detecting diseases, conditions, or states based on the analysis of these samples.
In summary, the INF 4160 PLUS is a therapeutic device used for pain management, not a diagnostic device used for analyzing biological samples.
N/A
Intended Use / Indications for Use
The INF 4160 PLUS is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
Product codes
LIH
Device Description
INF 4160 PLUS is an Interferential Current Therapy Device. It generates a set of symmetric sinusoidal electrical signals which are delivered to the user or patient through lead cables to the electrode pads placed on the skin. The electric signals stimulate the nerves underneath. The symptomatic relief from chronic intractable pain can be obtained from this electrical stimulation.
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)
Non-clinical Testing:
INF4160 PLUS complies with the following standard. EN60601-1 Safety requirement EN60601-1-2 EMC requirements
The design control follows the FDA quality system requirement and the software verification has been carried out according to the FDA software guidance.
Clinical Testing:
None
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
K092780 Device 510(k) number: _
1. Applicant Information
| Date Prepared: | Aug 20, 2009 | JAN - 7 2010 |
|---|---|---|
| Submitter: | Fuji Dynamics Ltd. | |
| Unit 1-3, 23/F., Laws Commercial Plaza | ||
| 788 Cheung Sha Wan Road, Kowloon | ||
| Hong Kong | ||
| Contact Person: | LEE, Ching Kong Felix | |
| Tel: | (852) 2786 4218 | |
| Fax: | (852) 2744 6775 |
General Device Information 2.
| Trade Name: | INF 4160 PLUS |
|---|---|
| Model Code: | D-FJ31F |
| Common Name: | Interferential Stimulator |
| Product Code: | LIH |
| Classification: | unclassified |
3. Predicate Device Information:
IF-4000 [510(k) No.: K952683]
4 Device Description
・
INF 4160 PLUS is an Interferential Current Therapy Device. It generates a set of symmetric sinusoidal electrical signals which are delivered to the user or patient through lead cables to the electrode pads placed on the skin. The electric signals stimulate the nerves underneath. The symptomatic relief from chronic intractable pain can be obtained from this electrical stimulation.
1
5 Intended Use:
INF4160 PLUS is intended to use as
- Symptomatic relief and management of chronic intractable pain .
- Adjunctive treatment for the management of post-traumatic or post-surgical . pain.
d Comparison to Predicate Device:
INF4160 PLUS has the following similarities when compared to the predicate device.
- The operating principle is the same. 트
- 트 The intended use is the same.
- 프 The power sourcing method is the same; both can operate with battery or AC adaptor.
7 Non-clinical Testing:
INF4160 PLUS complies with the following standard. EN60601-1 Safety requirement EN60601-1-2 EMC requirements
The design control follows the FDA quality system requirement and the software verification has been carried out according to the FDA software guidance.
Clinical Testing 8
None
9 Conclusions:
INF 4160 PLUS has the same intended use and the same technical characteristics as the predicate device, IF-4000 [510(k) No .: K952683].
INF4160 PLUS is as safe and as effective as the predicate device.
Therefore, the INF4160 PLUS is substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 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 perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Fuji Dynamics Limited c/o Mr. Ching Kong Lee Product Development Manager Unit 1-3, 23/F, Laws Commercial Plaza 788 Cheung Sha Wan Road Kowloon, Hong Kong China
JAN - 7 2010
Re: K092780
Trade/Device Name: INF 4160 PLUS Regulation Number: Unclassified Regulation Name: Interferential Current Therapy Regulatory Class: Unclassified Product Code: LIH Dated: November 26, 2009 Received: November 30, 2009
Dear Mr. Lee:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
3
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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.
Kesia Alexander Jr
Malvina B. Eydelman, M.I Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name: INF 4160 PLUS
Indications For Use:
The INF 4160 PLUS is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
X Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Joe C Callaway
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
K092780 510(k) Number
D-1/1