← Product Code [MQX](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MQX) · K031818 # FACILAI VARIOUS MODELS OF SINGLE USE ACUPUNCTURE NEEDLE (K031818) _Facilai Enterprises , Ltd. · MQX · Dec 3, 2003 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MQX/K031818 ## Device Facts - **Applicant:** Facilai Enterprises , Ltd. - **Product Code:** [MQX](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MQX.md) - **Decision Date:** Dec 3, 2003 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5580 - **Device Class:** Class 2 - **Review Panel:** General Hospital - **Attributes:** Therapeutic ## Indications for Use The device is intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states. ## Device Story Single-use acupuncture needle; intended for skin penetration during acupuncture therapy. Operated by qualified practitioners in clinical settings. Device facilitates traditional acupuncture procedures. No electronic, mechanical, or software components. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Single-use acupuncture needle. Class II device (Product Code: MQX). Regulation 880.5580. ## Regulatory Identification An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment. ## Special Controls *Classification.* Class II (special controls). The device, when it is an acupuncture point locator or a single use acupuncture needle, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9. Acupuncture needles must comply with the following special controls:(1) Labeling for single use only and conformance to the requirements for prescription devices set out in 21 CFR 801.109, (2) Device material biocompatibility, and (3) Device sterility. ## 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}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized representation of an eagle with three lines forming its body and wings. The eagle is facing to the right. ## Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC - 3 2003 Facilai Enterprise Limited C/O Dr. Ke- Min Jen Official Correspondent Roc-Chinese-Europe Industrial Research Society No. 58, Fu-Chiun Street Hsin-Chu City, CHINA (TAIWAN) 300 Re: K031818 K051618 Trade/Devicc Name: Facilai Various Models of Single Use Acupuncture Necdle Regulation Number: 880.5580 Regulation Name: Needle Acupuncture Regulatory Class: II Product Code: MQX Dated: October 28, 2003 Received: November 3, 2003 Dear Dr. Jen: 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 approvisions of the Act. The general controls provisions of the Act include controls providens of an 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 (1 wr y, it may of caefoot to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear over bublish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Page 2 - Dr. Jen 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 meall that FDA has made a autes and regulations administered by other Federal agencies. of the Act of ally I ederal bates and submitted to: requirements, including, but not limited to: registration 1 od mast comply with an the Heveling (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Pat 007), laceiity systems (QS) regulation (21 CFR Part 820); and if requirements as sections 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) This letter whilanon. 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), If you desire specific at . of Compliance at (301) 594-4618. Also, please note the regulation entified, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Susan Runos Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ K031818 ## 4. INDICATIONS FOR USE STATEMENT | Applicant : | FACILAI ENTERPRISE LTD. | |-----------------|------------------------------------------------------------| | 510(k) Number : | K031818 | | Device Name : | FACILAI VARIOUS MODELS OF SINGLE USE
ACUPUNCTURE NEEDLE | ## Indications for Use : - e The device is intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states. (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 __ (Optional Format 1-2-96) Palacie Crescenti eneral Hospital 510(k) Number: K031818 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MQX/K031818](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MQX/K031818) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com