(235 days)
Not Found
No
The summary describes a standard TENS device with different modes and a digital display. There is no mention of AI, ML, or any features that would suggest the use of such technologies for pain management or device operation.
Yes
Explanation: The device is a TENS unit, which is used for symptomatic relief and management of chronic intractable pain, making it a therapeutic device.
No
The device description states it is "intended for symptomatic relief and management of chronic intractable pain," which is a treatment function, not a diagnostic one.
No
The device description explicitly details hardware components such as a large LCD panel, battery power, lead-wires, and cutaneous stimulation electrodes, indicating it is a physical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "symptomatic relief and management of chronic intractable pain." This describes a therapeutic device that interacts with the patient's body, not a device used to examine specimens from the body to provide diagnostic information.
- Device Description: The description details a TENS (Transcutaneous Electrical Nerve Stimulation) device, which delivers electrical impulses to the skin for pain relief. This is a physical therapy modality, not an in vitro diagnostic method.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on specimens, or providing diagnostic information based on laboratory analysis.
Therefore, the SHIAN JIA MEEI DIGITAL PWM TENS is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SHIAN JIA MEEI DIGITAL PWM TENS is intended for symptomatic relief and management of chronic intractable pain.
Product codes (comma separated list FDA assigned to the subject device)
GZJ
Device Description
The SHIAN JIA MEEI DIGITAL PWM TENS (Transcutaneous Electrical Nerve Stimulation) is designed for symptomatic relief and management of chronic intractable pain. The device has eight stimulating modes providing the different feeling of effects, with mode setting. With large LCD panel. It is powered by three(3) AAA 1.5V Battery. SHIAN JIA MEEI DIGITAL PWM TENS requires the use of a set of lead-wire and one pair of cutaneous stimulation electrodes. Model No. description · YW-6000, UC-332 , UC-330 are identical in circuitry , LCD display , housing -etc. , except they are for different customers(destination). This means the three models ST-331 is identical to model YW-6000/UC-332 /UC-330 except the customers (destination) and the layout shown on the LCD display.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
In terms of operating specification, Safety & EMC requirements, the device conforms to applicable standards included EN 60601-1, EN 60601-1-2 & related FDA Output waveform requirements. Bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
TATUNG TMD-26AX Series TENS(K021794)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
0C1 1 -- 2004
Attachment E
510(K) SUMMARY
K 0403//1
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92
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- Submitter's Name: SHIAN JIA MEE! ENTERPRISE CO., LTD. NO.5,HUA YUAN 2ªº ST., PEI HUA VILLAG, KUANG MIAO HSIANG, Address: TAINAN HSIEN , TAIWAN . R.O.C. Tel: 886-6-5960879 Fax: 886-6-5950259 Contact: Mr. Michael Chen/General Manager E-mail: sim58129@ms65.hinet.net 2. Device Name SHIAN JIA MEEI DIGITAL PWM TENS Trade Name: Model No. : YW-6000/UC-330/ ST-331/ UC-332 Common Name: TENS unit Classification name: Transcutaneous Electrical Nerve Stimulator 3. Classification: Class II TATUNG TMD-26AX Series TENS(K021794) marketed by Tatung ঘ Predicate Device: Co.. The SHIAN JIA MEEI DIGITAL PWM TENS (Transcutaneous ട്. Device Description: Electrical Nerve Stimulation) is designed for symptomatic relief and management of chronic intractable pain. The device has eight stimulating modes providing the different feeling of effects, with mode setting. With large LCD panel. It is powered by three(3) AAA 1.5V Battery. SHIAN JIA MEEI DIGITAL PWM TENS requires the use of a set of lead-wire and one pair of cutaneous stimulation electrodes. Model No. description · YW-6000, UC-332 , UC-330 are identical in circuitry , LCD display , housing -etc. , except they are for different customers(destination). This means the three models ST-331 is identical to model YW-6000/UC-332 /UC-330 except the customers (destination) and the layout shown on the LCD display.
1
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- Performance Summary: In terms of operating specification, Safety & EMC requirements, the device conforms to applicable standards included EN 60601-1, EN 60601-1-2 & related FDA Output waveform requirements.
8. Conclusions:
The SHIAN JIA MEEI DIGITAL PWM TENS have the same intended use and similar technological characteristics as the TATUNG TMD-26AX Series TENS(K021794) marketed by Tatung Co.. Moreover, bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the SHIAN JIA MEEI DIGITAL PWM TENS is substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
OCT 1 - 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Jennifer Reich Representing Shian Jia Meei Enterprise Co., Ltd. 3892 South America West Trail Flagstaff, Arizona 86001
Re: K040311
Trade/Device Name: Shian Jia Meei Digital PWN TENS Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZJ Dated: undated Received: September 20, 2004
Dear Ms. Reich:
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 for are 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 product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Jennifer Reich
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 premated 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 Office of Compliance at (240) 276-0295. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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
(201) 115 0377 6. a. gov/cdrh/dsma/dsmamain. html
Sincerely yours,
Mark N. Milhener
Celia M. Witten, M.D., Ph.D. Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page _________________________________________________________________________________________________________________________________________________________________________
NUMBER (IF KNOWN): ___ Ko40311 510 (k)
DEVICE NAME: SHIAN JIA MEEI DIGITAL PWM TENS Model no.: YW-6000/UC-330/ST331/UC-332 SHIAN JIA MEEI ENTERPRISE CO., LTD.
INDICATIONS FOR USE:
The SHIAN JIA MEEI DIGITAL PWM TENS is intended for symptomatic relief and management of chronic intractable pain.
Mark N. Milkerem
Division Sign-Division of General, Restorative, and Neurological Devices
510(k) Number K040311
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
| Prescription Use | X |
|---|---|
| (Per 21 CER 801 109) |
OR
| Over-The-Counter | |
|---|---|
| ------------------ | -- |