(282 days)
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None
No
The summary does not contain any keywords or descriptions related to AI or ML technology. The device is described as a TENS device, which is a well-established technology that typically does not incorporate AI/ML.
Yes
The "Intended Use / Indications for Use" section explicitly states that TENS devices are used for "symptomatic relief and management of chronic (long-term) intractable pain" and as "adjunctive treatment in the management of post surgical and post traumatic acute pain problems," which are therapeutic applications.
No
Explanation: The device is indicated for symptomatic relief and management of pain, which is therapeutic, not diagnostic.
No
The device is described as a Transcutaneous Electrical Nerve Stimulator (TENS) device, which is inherently a hardware device that delivers electrical stimulation. 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 clearly states that the device is a Transcutaneous Electrical Nerve Stimulator (TENS) used for pain relief. This is a therapeutic device that interacts with the patient's body, not a diagnostic device that analyzes samples from the body.
- 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), detecting biomarkers, or providing diagnostic information.
- Device Type: TENS devices are well-established medical devices used for pain management, falling under the category of physical therapy or pain relief devices, not in vitro diagnostics.
Therefore, based on the provided text, this device is a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
INDICATIONS: Transcutaneous Electrical Nerve Stimulator (TENS) devices are used for the symptomatic relief and management of chronic (long-term) intractable pain and as adjunctive treatment in the management of post surgical and post traumatic acute pain problems.
CONTRAINDICATIONS: TENS devices can affect the operation of demand type cardiac pacemakers. TENS is not recommended for patients with know heart disease without physical evaluation of possible risk. Do not stimulate over the eyes or carotid sinus nerves. Do not apply TENS for undiagnosed pain syndromes until the etiology is established.
Product codes
GZJ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 9 1998
Mr. Daniel Lee President Apex Medical Corporation 10th Floor, Number 31, Lane 169 Kang Ning Street HSI Chih Chen, Taipei Hsien Taiwan R.O.C.
Re: K973979 Multi-Stim TENS, AP-101081T Trade Name: K973980 Acu-Stim TENS, AP-101082T Trade Name: Regulatory Class: II Product Code: GZJ June 2, 1998 Dated: Received: July 2, 1998
Dear Mr. Lee:
We have reviewed your Section 510(k) notifications of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) to 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). You may, therefore, market the devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with -----the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action.
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Page 2 - Mr. Daniel Lee
concerning your devices in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
ia M. Witten/ Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
2
510(k) Number (if known):
ACU-STIM TENS Device Name:
Indications For Use:
INDICATIONS: Transcutaneous Electrical Nerve Stimulator (TENS) devices are used for the symptomatic relief and management of chronic (long-term) intractable pain and as adjunctive treatment in the management of post surgical and post traumatic acute pain problems.
CONTRAINDICATIONS: TENS devices can affect the operation of demand type cardiac paccmakers. TENS is not recommended for patients with know heart disease without physical evaluation of possible risk. Do not stimulate over the eyes or carotid sinus nerves. Do not apply TENS for undiagnosed pain syndromes until the etiology is established.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109
OR
Over-The-Counter Use
(Optional Format 1-2-96)
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