Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart F — General Hospital and Personal Use Therapeutic Devices](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices) → [21 CFR 880.5580](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5580) → MQX — Needle, Acupuncture, Single Use # MQX · Needle, Acupuncture, Single Use _General Hospital · 21 CFR 880.5580 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MQX ## Overview - **Product Code:** MQX - **Device Name:** Needle, Acupuncture, Single Use - **Regulation:** [21 CFR 880.5580](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5580) - **Device Class:** 2 - **Review Panel:** [General Hospital](/submissions/HO) ## 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. ## Classification Rationale 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: ## 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. ## Recent Cleared Devices (20 of 91) Showing 20 most recent of 91 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K162566](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MQX/K162566.md) | AIK Sterile Acupuncture Needles for Single Use | Changchun Aik Medical Devices Co., Ltd. | May 11, 2017 | SESE | | [K142760](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MQX/K142760.md) | Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles | K.S. Choi Corporation | Aug 25, 2015 | SESE | | [K150903](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MQX/K150903.md) | EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR, ACUKING, Myotech Dry, Red Coral Premium, Red Coral J-Type, Red Coral Natural | Maanshan Bond Medical Instruments Co., Ltd. | Jul 15, 2015 | SESE | | [K142920](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MQX/K142920.md) | KM Needles (Acupuncture Needle) | K.M.S., Inc. | Jun 10, 2015 | SESE | | [K141473](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MQX/K141473.md) | SMC ACUPUNCTURE NEEDLE | Smc Intl., Inc. | Aug 1, 2014 | SESE | | [K132896](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MQX/K132896.md) | CJ-TYPE: METAL HANDLE WITH GUIDE TUBE, PJ-TYPE: PLASTIC HANDLE WITH GUIDE TUBE, CB-TYPE: METAL HANDLE WITHOUT GUIDE TUBE | Asia-Med GmbH and CO KG | Dec 2, 2013 | SESE | | [K111392](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MQX/K111392.md) | WOOJEON ACUPUNCTURE NEEDLE (=SERA ACUPUNCTURE NEEDLE) | Woojeon Company | Nov 4, 2011 | SESE | | [K103061](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MQX/K103061.md) | BIOMATE STERILE ACUPUNCTURE NEEDLE | Biomate Medical Devices Technology Co., Ltd. | Jun 20, 2011 | SESE | | [K092240](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MQX/K092240.md) | ACUPUNCTURE NEEDLES | Haenglim Seowon Medical Co. | Apr 21, 2010 | SESE | | [K090199](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MQX/K090199.md) | JIAJIAN ACUPUNCTURE NEEDLE | Wuxi Jiajian Medical Instrument Co., Ltd. | Aug 11, 2009 | SESE | | [K090910](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MQX/K090910.md) | HANSO ACUPUNCTURE NEEDLE | Hansol Medical Co. | Jun 30, 2009 | SESE | | [K071524](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MQX/K071524.md) | TCMNATURELMED, HEALTHCARE, BLOODCARE, BO'S ABDOMINAL | Tcm World, Inc. | Apr 10, 2008 | SESE | | [K072778](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MQX/K072778.md) | BRIO ACUPUNCTURE NEEDLES | Helio Medical Supplies, Inc. | Nov 19, 2007 | SESE | | [K061517](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MQX/K061517.md) | PRECISION PRESS TACK / INTRADERM, SEVEN STAR AND ACUPUNCTURE NEEDLES; ALPHA AND FINE POINT ACUPUNCTURE NEEDLES | Prime Herbs Corporation | Nov 22, 2006 | SESE | | [K062448](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MQX/K062448.md) | LYRA ACUPUNCTURE NEEDLES | Helio Medical Supplies, Inc. | Sep 20, 2006 | SESE | | [K060392](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MQX/K060392.md) | ASP TITANIUM | Sedatelec | Apr 26, 2006 | SESE | | [K052731](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MQX/K052731.md) | KANGSHENG BRAND/KANGNIAN BRAND/UNILINK BRAND/HUAZHONG BRAND ACUPUNCTURE NEEDLES | Daxin LI | Feb 1, 2006 | SESE | | [K052723](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MQX/K052723.md) | SEVEN STAR NEEDLE | Helio Medical Supplies, Inc. | Jan 13, 2006 | SESE | | [K052846](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MQX/K052846.md) | TEWA CJ-TYPE, PJ-TYPE, CB-TYPE AND PB-TYPE ACUPUNCTURE NEEDLES FOR SINGLE USE | Maanshan Medical Instruments Co., Ltd. | Dec 22, 2005 | SESE | | [K052085](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MQX/K052085.md) | STANDARD, SPECIAL, SPECIAL+, SNEEDLE B-TYPE AND SNEEDLE J-TYPE ACUPUNCTURE NEEDLES | Asia-Med GmbH and CO KG | Oct 14, 2005 | SESE | ## Top Applicants - Helio Medical Supplies, Inc. — 10 clearances - Lhasa Medical, Inc. — 9 clearances - American Institute of Koryo Hand Therapy — 5 clearances - Asia-Med GmbH and CO KG — 4 clearances - Seirin-America, Inc. — 4 clearances --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MQX](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MQX) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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