(213 days)
Not Found
None
No
The summary does not mention AI, ML, or any related terms, and the device description is for a standard TENS unit.
Yes
The device is described for symptomatic relief and management of chronic, intractable pain and acute pain problems, which fits the definition of a therapeutic device.
No
The document describes the device as providing symptomatic relief and management of pain, which aligns with therapeutic rather than diagnostic purposes. There is no mention of the device being used to identify or analyze a medical condition.
No
The device description "Sanidad TENS-Duo Mode GP8016N" and the intended use for pain relief strongly suggest this is a Transcutaneous Electrical Nerve Stimulation (TENS) device, which is a hardware-based medical device that delivers electrical impulses. The summary does not mention any software-only components or functions.
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 symptomatic relief and management of pain. This is a therapeutic use, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is described as a TENS (Transcutaneous Electrical Nerve Stimulation) unit. TENS devices deliver electrical impulses to the body for pain relief.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information.
Therefore, the Sanidad TENS-Duo Mode GP8016N is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Specific indications: it is used for the symptomatic relief and management of chronic, intractable pain and as an adjunctive treatment in the management of post surgical and post traumatic acute pain problems. Clinical settings: should be used under the instruction or prescription by qualified health professionals prior to the applications of the device at home or hospital facilities.
Product codes
GZJ
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
qualified health professionals prior to the applications of the device at home or hospital facilities.
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)
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is black and the background is white.
DEC 02 2002
Dr. Jen. Ke-Min ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun St. Hsin-Chu Citv. Taiwan. ROC
Re: K021430
Trade/Device Name: Sanidad TENS-Duo Mode GP8016N Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZJ Dated: October 18, 2002 Received: October 25, 2002
Dear Dr. Jen:
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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic
1
Page 2 - Dr. Jen
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4639. Additionally, for questions on the promotion and advertising of your device, please contact the 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 yours,
Miriam C. Provost
for 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
ROLOR ELECTRONICS CORPORATION SANIDAD HEALTH INDUSTRIES, INC.
No. 274, Nanking E. Road, Sec. 5, Taipei, Taiwan, R.O.C. P.O. Box 46-379 TEL: 886-2-27682174-5, FAX: 886-2-27605922 Email: webmaster@rolor.com, http://www.rolor.com
| Indications for Use Statement |
|---|
| ------------------------------- |
| Ver/ 3-4/24/96 |
|---|
| ---------------- |
| Applicant: | ROLOR ELECTRONICS CORPORATION |
|---|---|
| 510(k) Number ( if known): | K621430 |
| Device Name: | Sanidad TENS-Duo Mode GP8016N |
| Indications For Use : |
|---|
| Specific indications: it is used for the symptomatic relief and management of chronic, intractable pain and as an adjunctive treatment in the management of post surgical and post traumatic acute pain problems.Clinical settings: should be used under the instruction or prescription by qualified health professionals prior to the applications of the device at home or hospital facilities. |
( PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON
ANOTHER PAGE IF NEEDED )
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| Miriam C. Provost | |
|---|---|
| Division of General, Restorative and Neurological Devices | |
| (Per 21 CFR 801.109) |
| K621430 | |
|---|---|
| -- | --------- |
| ( Optional Format 1-2-96) | |
|---|---|
| -- | --------------------------- |