← Product Code [GZJ](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZJ) · K040311 # SHIAN JIA MEEI DIGATAL PWN TENS, MODEL YW-6000/UC-332/UC-330/ST-331 (K040311) _Shian Jia Meei Enterprise Co., Ltd. · GZJ · Oct 1, 2004 · Neurology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZJ/K040311 ## Device Facts - **Applicant:** Shian Jia Meei Enterprise Co., Ltd. - **Product Code:** [GZJ](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZJ.md) - **Decision Date:** Oct 1, 2004 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 882.5890 - **Device Class:** Class 2 - **Review Panel:** Neurology - **Attributes:** Therapeutic ## Indications for Use The SHIAN JIA MEEI DIGITAL PWM TENS is intended for symptomatic relief and management of chronic intractable pain. ## Device Story Device is a Transcutaneous Electrical Nerve Stimulator (TENS) for symptomatic relief and management of chronic intractable pain. Input: user-selected stimulation modes via device interface. Operation: device generates electrical pulses delivered through lead-wires and cutaneous electrodes to the patient. Features eight stimulation modes and a large LCD panel. Power source: three 1.5V AAA batteries. Used by patients for pain management. Output: electrical stimulation to the skin. Healthcare providers use the device to provide non-pharmacological pain relief; patient benefits from reduced pain symptoms. ## Clinical Evidence Bench testing only. Device conforms to EN 60601-1, EN 60601-1-2, and FDA output waveform requirements. ## Technological Characteristics TENS unit; battery-powered (3x 1.5V AAA); 8 stimulation modes; LCD interface; cutaneous electrodes and lead-wires. Conforms to EN 60601-1 and EN 60601-1-2 standards. ## Regulatory 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. ## Predicate Devices - TATUNG TMD-26AX Series TENS ([K021794](/device/K021794.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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 - 1. 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}------------------------------------------------ - 7. 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 | | |------------------|--| |------------------|--| --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZJ/K040311](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZJ/K040311) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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