(287 days)
Not Found
No
The summary describes a simple electronic pulse generator for pain relief (TENS) and does not mention any AI or ML capabilities.
Yes
Justification: The device description states its intended use is "for relief of chronic or acute pain" and specifically mentions "post-traumatic acute pain (TENS)", which clearly falls under therapeutic purposes.
No
Explanation: The device is intended for pain relief, which is a therapeutic purpose, not a diagnostic one. It generates pulses for treatment (TENS), not for identifying or characterizing a medical condition.
No
The device description explicitly states it is a "portable hand held battery operated micro current pulse generator," indicating it is a hardware device that generates electrical pulses.
Based on the provided information, the MEDIPOINT device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "relief of chronic or acute pain" and is described as an "electronic pulse generator" for pain relief (TENS). This is a therapeutic use, not a diagnostic one.
- Device Description: The description details a "portable hand held battery operated micro current pulse generator." This describes a physical therapy or pain management device, not something used to test samples from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a disease or condition.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The MEDIPOINT device does not fit this description.
N/A
Intended Use / Indications for Use
MEDIPOINT is intended for relief of chronic or acute pain.
MEDIPOINT is an electronic pulse generator that has been designed to provide relief of chronic, intractable pain and post-traumatic acute pain (TENS).
Product codes
GZJ
Device Description
MEDIPOINT is a portable hand held battery operated micro current pulse generator Pusing a very minute biphasic DC current.
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)
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
Medipoint Ltd. 12 Wolfe Close Parkgate Business Park, Knutsford Cheshire, WA16 8XJ, UK
MEDIPOINT 510(K) Premarket Notification Dated: August 5, 1998
510(k) Summary 10.
MEDIPOINT, MICROCURRENT THERAPY
Contact: Larry Ratliff Medipoint USA Pocatella, Idaho 83204
Tel: (208) 232-2941
Sponsor: Medipoint Ltd. 12 Wolfe Close Parkgate Business Park, Knutsford Chesire, WA16 8XJ, UK
Tel: 01565 632000
Notice: This document is propriety and its contents are the exclusive property of Medipoint Ltd. This ડી document may not be reproduced in any form without the specific permission of Medipoint Ltd.
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1
MEDIPOINT 510(K) Premarket Notification Dated: August 5, 1998
10. 1. Device Name
MEDIPOINT is provided as follows:
- a. Trade Name MEDIPOINT
- b. Common Name Microcurrent Therapy
- c. Classification Name
- 21 CFR Sec. 882.5890 Transcutaneous electrical nerve stimulator . for pain relief
10. 2. Predicate Device / Company Names and Addresses
The predicate device is listed below with its 510(k) clearance number.
| SOLITENS™ | K(913522) | INNOVATIVE DESIGNER PRODUCTS, INC.
Saul Liss
175 Rock Road
Glen Rock, NJ 07452 |
| ----------- | ----------- | ----------------------------------------------------------------------------------------- |
|---|
10. 3. Description of Device
MEDIPOINT is a portable hand held battery operated micro current pulse generator Pusing a very minute biphasic DC current.
10. 4. Intended Use
MEDIPOINT is intended for relief of chronic or acute pain.
Notice: This document is propriety and its contents are the exclusive property of Medipoint Ltd. This ട് 2 document may not be reproduced in any form without the specific permission of Medipoint Ltd.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure with three lines extending from its head, resembling a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 7 1999
Jules T. Mitchel, Ph.D. Target Health Inc. Representing Medipoint_Limited Representing nearpoint 22mlood New York, New York 10017
K982961 Re: Medipoint Trade Name: Requlatory Class: II Product Code: GZJ March 9, 1999 Dated: March 10, 1999 Received:
Dear Dr. Mitchel:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) 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 device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 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 regulation (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. concerning your device 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.
3
Page 2 - Jules T. Mitchel, Ph.D.
This letter will allow you to begin marketing your device as described in your 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 requlation (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 device, please contact the Office of Compliance at (301) 594-4639. Also, please note one 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,
Celia M. Witten, PH.D., M.D.
Director
Division of General and
Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Attachment I b
Page / of /
| Labels | Values |
|---|---|
| 510(k) Number (if known): | K982961 |
| Device Name: | Mediprint |
Indications For Use:
MEDIPOINT is an electronic pulse generator that has been designed to provide in MEDIPOINT IS an electionic pulse generator that has has has and post-traumatic acute pain (TENS).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
Division of General Restorative Devices
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K98296
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)