(30 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description is for a standard electrical stimulator.
Yes
The device is described as an "Interferential Stimulator" and its intended use is for "symptomatic relief and management of chronic pain and/or as an adjunctive treatment in the management of postsurgical and post-traumatic acute pain," which are therapeutic applications.
No
The device, an "Interferential Stimulator," is described as being used for "symptomatic relief and management of chronic pain and/or as an adjunctive treatment in the management of postsurgical and post-traumatic acute pain." This indicates a therapeutic, not diagnostic, purpose. There is no mention of identifying, classifying, or detecting diseases or conditions.
No
The device description explicitly states "Interferential Stimulator Model BMLS03-6", which is a hardware device used for electrical stimulation. The summary does not mention any software component as the primary or sole function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used for symptomatic relief and management of pain. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is described as an "Interferential Stimulator," which is a type of electrotherapy device used to deliver electrical currents to the body for therapeutic purposes.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a disease or condition based on the analysis of biological samples.
- Using reagents or other materials to perform tests on biological samples.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to deliver electrical stimulation for pain relief, which falls under the category of physical therapy or pain management devices, not IVDs.
N/A
Intended Use / Indications for Use
Interferential Stimulation is used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment in the management of postsurgical and post-traumatic acute pain.
Product codes
LIH
Device Description
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three wing-like shapes, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The logo is printed in black ink.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 9 2004
Richard Saxon President Biomedical Life Systems, Inc. P.O. Box 1360 Vista, California 92085-1360
Re: K040824
Trade/Device Name: Interferential Stimulator, Model BMLS03-6 Regulation Number: unclassified Regulation Name: Interferential Stimulator Regulatory Class: Unclassified Product Code: LIH Dated: Undated Received: April 9, 2004
Dear Mr. Saxon:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your rocuon 910(x) prodecise is substantially equivalent (for the indications for relered above and have are are and marketed predicate devices marketed in interstate commerce use stated in the encreasury hate of the Medical Device Amendments, or to devices that provi to Nay 26, 1970, the chactinent with the provisions of the Federal Food, Drug, and Cosmetic Act flact) that do not require approval of a premarket approval application (PMA). You may, therefore, (Act) that do not require appreval controls provisions of the Act. The general controls market the act the Act include requirements for annual registration, listing of devices, good provisions of the rectmerate reg, and prohibitions against misbranding and adulteration.
If your device is classificd (see above) into either class II (Special Controls) or class III (PMA), it may it your aceree is oldsmited (oe are to, Existing major regulations affecting your device can be found be subject to such additional connects. Extrains - 3 - 3 - 3 - 3 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 1 - addition, FDA may publish f announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination docs not mean that I tease be advised mat i 27 t ion 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 r coolal statution and regulation but not limited to: registration and listing (21 CFR Part 807); labeling (21 CliR 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.
1
Page 2 – Mr. Richard Saxon
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter wif and in you to begal finding of substantial equivalence of your device to a legally premarket notification - 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 CFR 1659. Additionally, for questions on the promotion and advertising of your Compliation (1301) 59 - 1 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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/dsma/dsmamain.html
Sincerely vours,
Mark N. Millman
Celia M. Witten, Ph.D., M.D. Director
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
Interferential Stimulator Model BMLS03-6
Indications for Use:
Interferential Stimulation is used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment in the management of postsurgical and post-traumatic acute pain.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21CFR807 Subpart C)
(Please do NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N. Millman
al. Restorative. and Neurological Devices
510(k) Number K040829