MQX · Needle, Acupuncture, Single Use
General Hospital · 21 CFR 880.5580 · Class 2
Overview
| Product Code | MQX |
|---|---|
| Device Name | Needle, Acupuncture, Single Use |
| Regulation | 21 CFR 880.5580 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
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 | AIK Sterile Acupuncture Needles for Single Use | Changchun Aik Medical Devices Co., Ltd. | May 11, 2017 | SESE |
| K142760 | Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles | K.S. Choi Corporation | Aug 25, 2015 | SESE |
| K150903 | 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 | KM Needles (Acupuncture Needle) | K.M.S., Inc. | Jun 10, 2015 | SESE |
| K141473 | SMC ACUPUNCTURE NEEDLE | Smc Intl., Inc. | Aug 1, 2014 | SESE |
| K132896 | 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 | WOOJEON ACUPUNCTURE NEEDLE (=SERA ACUPUNCTURE NEEDLE) | Woojeon Company | Nov 4, 2011 | SESE |
| K103061 | BIOMATE STERILE ACUPUNCTURE NEEDLE | Biomate Medical Devices Technology Co., Ltd. | Jun 20, 2011 | SESE |
| K092240 | ACUPUNCTURE NEEDLES | Haenglim Seowon Medical Co. | Apr 21, 2010 | SESE |
| K090199 | JIAJIAN ACUPUNCTURE NEEDLE | Wuxi Jiajian Medical Instrument Co., Ltd. | Aug 11, 2009 | SESE |
| K090910 | HANSO ACUPUNCTURE NEEDLE | Hansol Medical Co. | Jun 30, 2009 | SESE |
| K071524 | TCMNATURELMED, HEALTHCARE, BLOODCARE, BO'S ABDOMINAL | Tcm World, Inc. | Apr 10, 2008 | SESE |
| K072778 | BRIO ACUPUNCTURE NEEDLES | Helio Medical Supplies, Inc. | Nov 19, 2007 | SESE |
| K061517 | PRECISION PRESS TACK / INTRADERM, SEVEN STAR AND ACUPUNCTURE NEEDLES; ALPHA AND FINE POINT ACUPUNCTURE NEEDLES | Prime Herbs Corporation | Nov 22, 2006 | SESE |
| K062448 | LYRA ACUPUNCTURE NEEDLES | Helio Medical Supplies, Inc. | Sep 20, 2006 | SESE |
| K060392 | ASP TITANIUM | Sedatelec | Apr 26, 2006 | SESE |
| K052731 | KANGSHENG BRAND/KANGNIAN BRAND/UNILINK BRAND/HUAZHONG BRAND ACUPUNCTURE NEEDLES | Daxin LI | Feb 1, 2006 | SESE |
| K052723 | SEVEN STAR NEEDLE | Helio Medical Supplies, Inc. | Jan 13, 2006 | SESE |
| K052846 | 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 | 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
