(240 days)
Not Found
No
The summary describes a standard electrotherapy device with electrodes, lead wires, and a signal generator. There is no mention of AI, ML, or any related concepts in the device description, intended use, or performance study sections. The "Mentions AI, DNN, or ML" field explicitly states "Not Found".
Yes
The device is indicated for use as an adjunctive therapy to reduce pain and symptoms associated with specific medical conditions (Osteoarthritis of the knee and Rheumatoid Arthritis of the Hand), which aligns with the definition of a therapeutic device.
No
The device is described as an "adjunctive therapy" for reducing pain and symptoms, and it produces a "pulsed electrical signal" for treatment. It does not mention identifying or characterizing a disease or condition.
No
The device description explicitly states that the J-Stim 1000 consists of hardware components: electrodes, lead wires, and a signal generator (stimulator). This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, the J-Stim 1000 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the J-Stim 1000 is an "adjunctive therapy in reducing the level of pain and symptoms associated with Osteoarthritis of the knee and Rheumatoid Arthritis of the Hand." This describes a therapeutic device that acts on the body, not a device used to examine specimens taken from the body.
- Device Description: The description details an "external, non-invasive, non-narcotic, electrotherapy system" that applies electrical signals to the body via electrodes. This is consistent with a therapeutic device, not an IVD.
- Anatomical Site: The device is applied to the "Knee, Hand," which are external anatomical sites for treatment, not locations from which specimens are typically collected for in vitro diagnostics.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), performing tests on samples outside the body, or providing diagnostic information based on such analysis.
In summary, the J-Stim 1000 is a therapeutic device used to treat pain and symptoms, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The J-Stim 1000™ external, non-invasive, non-narcotic, electrotherapy system is indicated for use as an adjunctive therapy in reducing the level of pain and symptoms associated with osteoarthritis of the knee and for overall improvement of the knee.
The J-Stim 1000™ is also indicated for use as an adjunctive therapy in reducing the level of pain, and stiffness associated with pain, from rheumatoid arthritis of the hand.
These devices are to be used or sold only under the direct supervision or order of a licensed practitioner. A prescription is required to obtain this product. The product can be used in the home or clinic by all patients in need.
Product codes
NYN
Device Description
The J-Stim 1000 consists of electrodes, the lead wires, and the signal generator. The Stimulator is portable, battery operated and rechargeable. The Lead wires connect the electrodes to the stimulator. These electrodes complete an electrical circuit allowing current to flow. The stimulator produces a pulsed electrical signal through the lead wires and electrodes at the treatment site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee, hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed practitioner, home or clinic
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)
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
Ko73386
JUL 3 0 2008
"
. .
Pain Management Technologies, Inc. 510(k) submission J-Stim 1000™
510(k) Summary of Safety and Effectiveness (As described in 21 CFR 807.92)
| Date Prepared: | 11-1-07 |
|---|---|
| Trade Name/Device: | J-Stim 1000™ |
| Applicant Information: | Pain Management Technologies, Inc. |
| 1340 Home Ave. Bldg. A | |
| Akron, OH 44310 | |
| 800-239-7880 (phone) | |
| 888-304-5454 (fax) | |
| Contact: Joshua Lefkovitz | |
| Registration No. 1528161 | |
| Device Generic Name: | TENS (Transcutaneous Electrical Nerve Stimulator) |
| Classification: | Class II (21CFR 882.1320) |
| Classification Name: Transcutaneous electrical nerve | |
| stimulator for pain relief | |
| Product Code: NYN | |
| Regulation number 21 CFR 882.5890 | |
| Predicate Devices: | The Bionicare Stimulator, Model Bio 1000 - K030332 |
| and the K052625 |
.
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| Device Description: | The J-Stim 1000 consists of electrodes, the lead wires, and the signal generator. The Stimulator is portable, battery operated and rechargeable. The Lead wires connect the electrodes to the stimulator. These electrodes complete an electrical circuit allowing current to flow. The stimulator produces a pulsed electrical signal through the lead wires and electrodes at the treatment site. |
|---|---|
| Statement of intended use: | The J-Stim 1000 is indicated for use as an adjuctive therapy in reducing the level of pain and symptoms associated with Osteoarthritis of the knee and Rheumatoid Arthritis of the Hand. |
Summary of technology of the J-Stim vrs. the predicate Bionicare device:
The J-Stim 1000 and the Bionicare 1000 generate the exact same clectrical output. They produce the same frequency. The same wave form as a monophasic spiked shaped pulse. The same voltage output range which is 0-12 volts peak, as well as the same dual channel output performance. Pulse widths and max output values are identical as well. The J-Stim 1000 utilizes an LCD screen to display the settings
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Pain Management Technologies % Mr. Joshua Lefkovitz President 1340 Home Avenue, Building A Akron, Ohio 44310
JUL 30 2008
K073386 Trade/Device Name: J-Stim 1000™ Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief. Regulatory Class: Class II Product Code: NYN Dated: June 6, 2008 Received: June 13, 2008
Dear Mr. Lefkovitz:
Re:
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
3
Page 2 - Mr. Joshua Lefkovitz
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.
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.
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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours.
Mark M. Mulkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Pain Management Technologies, Inc. 510(k) submission J-Stim 1000TM
Indications for Use Statement
510k Number:K073386
Device Name: J-Stim 1000TM
Indication for Use:
The J-Stim 1000781 external, non-invasive, non-narcotic, electrotherapy system is indicated for use as an adjunctive therapy in reducing the level of pain and symptoms associated with osteoarthritis of the knee and for overall improvement of the knee.
The J-Stim 1000™ is also indicated for use as an adjunctive therapy in reducing the level of pain, and stiffness associated with pain, from rheumatoid arthritis of the hand.
These devices are to be used or sold only under the direct supervision or order of a licensed practitioner. A prescription is required to obtain this product. The product can be used in the home or clinic by all patients in need.
| Prescription Use
(Part 21 CFR 801 Subpart D) | √ | AND/OR | Over-The-Counter Use
(21 CFR 801 Subpart C) | |
| ------------------------------------------------- | --- | -------- | ------------------------------------------------ | -- |
|---|
(PLEASE DO NOT WRITE BELOW THIS LINE)
Division Sign Off ONE ON ANOTHER PAGE
(IF NEEDED)
Division of General, Restorative,
and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________