Sterile Acupuncture Needles FOR Single USE
AIK Sterile Acupuncture Needles are single-use stainless steel instruments with a needle body and a coiled-wire handle. The fine needle body forms the tissue-penetrating part, and the…
AIK Sterile Acupuncture Needles are single-use stainless steel instruments with a needle body and a coiled-wire handle. The fine needle body forms the tissue-penetrating part, and the handle provides the grip used during placement.
The body uses 304 stainless steel, while the handle is formed from symmetrically arranged stainless steel wire loops. Versions are available with or without a guide tube.
Listed Item
The AIK Sterile Acupuncture Needles are manufactured from stainless steel and sterilized with ethylene oxide gas. Ten needles with one tube per sterile, individually blister package, 1000 needles per box.
Sizes and Supply
The range includes body diameters from 0.14 to 0.35 mm and lengths from 13 to 75 mm. Needles are sterilized with ethylene oxide and intended for use by qualified acupuncture practitioners, with packaging configuration determined by the selected model.
33manufacturers in China registered for this device type
397catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (17), Zhejiang (3), Tianjin (3).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Suzhou Hengxiang IMP. & EXP. Co., Ltd. | Suzhou | Jiangsu | Exporter | 35 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
| Suzhou Pulikang Medical Device Co Ltd | Suzhou | Jiangsu | Remanufacturer | 26 |
| Wuxi Goals Medical Technology Co., Ltd. | Yixing | Jiangsu | Contract manufacturer | 24 |
| Shenzhen Joose Beauty Electronic Co., Ltd. | Shen Zhen | Guangdong | Contract manufacturer | 13 |
| Hangzhou Goals Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 11 |
| Changsha Gomecy Electronics Co., Ltd. | Changsha | Hunan | Contract manufacturer | 9 |
| Tianjin Empecs Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 8 |
| Guangzhou Ahead Intelligent Technology Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 7 |
| Tianjin Huahong Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 6 |
| Wuxi Jiajian Medical Instrument Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 6 |
Showing 12 of 33. All 33 manufacturers in China registered for Needle, Acupuncture, Single Use
Record
| Listed by | Changchun AIK Medical Devices Co., Ltd., China |
|---|---|
| FDA product code | MQX |
| Device type | Needle, Acupuncture, Single Use |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5580 |
| Establishment | Manufacturer |
| 510(k) | K162566 |
| Record published | 2019-09-25 |
| Record revised | 2019-09-13 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 0.35*75 | 100 | In distribution | |
| 0.30*25 | 100 | In distribution | |
| 0.30*40 | 500 | In distribution | |
| 0.40*25 | 100 | In distribution | |
| 0.35*25 | 500 | In distribution | |
| 0.25*25 | 100 | In distribution | |
| 0.30*60 | 500 | In distribution | |
| 0.20*13 | 100 | In distribution | |
| 0.22*15 | 100 | In distribution | |
| 0.40*60 | 100 | In distribution | |
| 0.22*13 | 1,000 | In distribution | |
| 0.35*60 | 500 | In distribution | |
| 0.25*13 | 100 | In distribution | |
| 0.30*50 | 1,000 | In distribution | |
| 0.18*25 | 100 | In distribution | |
| 0.35*60 | 100 | In distribution | |
| 0.22*15 | 1,000 | In distribution | |
| 0.35*50 | 100 | In distribution | |
| 0.25*40 | 100 | In distribution | |
| 0.35*13 | 100 | In distribution | |
| 0.22*15 | 100 | In distribution | |
| 0.25*15 | 100 | In distribution | |
| 0.22*50 | 500 | In distribution | |
| 0.35*40 | 1,000 | In distribution | |
| 0.30*50 | 100 | In distribution | |
| 0.35*60 | 1,000 | In distribution | |
| 0.35*15 | 100 | In distribution | |
| 0.20*15 | 100 | In distribution | |
| 0.16*13 | 500 | In distribution | |
| 0.35*75 | 500 | In distribution | |
| 0.25*50 | 100 | In distribution | |
| 0.20*15 | 100 | In distribution | |
| 0.30*75 | 100 | In distribution | |
| 0.25*60 | 100 | In distribution | |
| 0.25*50 | 100 | In distribution | |
| 0.22*50 | 500 | In distribution | |
| 0.35*50 | 1,000 | In distribution | |
| 0.30*25 | 100 | In distribution | |
| 0.20*30 | 100 | In distribution | |
| 0.22*50 | 100 | In distribution | |
| 0.25*50 | 100 | In distribution | |
| 0.35*13 | 100 | In distribution | |
| 0.22*15 | 100 | In distribution | |
| 0.18*25 | 1,000 | In distribution | |
| 0.30*30 | 100 | In distribution | |
| 0.25*40 | 100 | In distribution | |
| 0.18*8 | 100 | In distribution | |
| 0.16*25 | 100 | In distribution | |
| 0.35*100 | 100 | In distribution | |
| 0.35*30 | 100 | In distribution | |
| 0.22*30 | 500 | In distribution | |
| 0.22*25 | 500 | In distribution | |
| 0.22*30 | 100 | In distribution | |
| 0.20*30 | 1,000 | In distribution | |
| 0.18*15 | 100 | In distribution | |
| 0.30*40 | 100 | In distribution | |
| 0.16*30 | 1,000 | In distribution | |
| 0.16*13 | 1,000 | In distribution | |
| 0.40*30 | 500 | In distribution | |
| 0.22*13 | 100 | In distribution | |
| 0.30*13 | 100 | In distribution | |
| 0.35*15 | 100 | In distribution | |
| 0.22*13 | 500 | In distribution | |
| 0.40*75 | 500 | In distribution | |
| 0.20*13 | 100 | In distribution | |
| 0.20*50 | 500 | In distribution | |
| 0.30*13 | 100 | In distribution | |
| 0.25*40 | 100 | In distribution | |
| 0.35*60 | 100 | In distribution | |
| 0.35*50 | 100 | In distribution | |
| 0.18*13 | 500 | In distribution | |
| 0.40*75 | 100 | In distribution | |
| 0.35*100 | 100 | In distribution | |
| 0.25*13 | 500 | In distribution | |
| 0.30*15 | 500 | In distribution | |
| 0.20*50 | 100 | In distribution | |
| 0.30*40 | 1,000 | In distribution | |
| 0.30*50 | 500 | In distribution | |
| 0.16*15 | 100 | In distribution | |
| 0.22*25 | 100 | In distribution | |
| 0.40*40 | 500 | In distribution | |
| 0.30*25 | 100 | In distribution | |
| 0.16*15 | 100 | In distribution | |
| 0.22*60 | 100 | In distribution | |
| 0.30*15 | 1,000 | In distribution | |
| 0.16*15 | 1,000 | In distribution | |
| 0.20*40 | 1,000 | In distribution | |
| 0.35*25 | 100 | In distribution | |
| 0.25*75 | 100 | In distribution | |
| 0.22*40 | 500 | In distribution | |
| 0.16*25 | 100 | In distribution | |
| 0.30*40 | 100 | In distribution | |
| 0.25*40 | 100 | In distribution | |
| 0.30*75 | 100 | In distribution | |
| 0.35*40 | 500 | In distribution | |
| 0.25*15 | 100 | In distribution | |
| 0.20*40 | 100 | In distribution | |
| 0.16*13 | 100 | In distribution | |
| 0.35*75 | 100 | In distribution | |
| 0.20*15 | 100 | In distribution | |
| 0.22*50 | 100 | In distribution | |
| 0.25*30 | 100 | In distribution | |
| 0.20*13 | 100 | In distribution | |
| 0.35*40 | 100 | In distribution | |
| 0.35*50 | 100 | In distribution | |
| 0.35*30 | 100 | In distribution | |
| 0.20*25 | 100 | In distribution | |
| 0.18*13 | 100 | In distribution | |
| 0.20*50 | 500 | In distribution | |
| 0.40*50 | 500 | In distribution | |
| 0.25*50 | 500 | In distribution | |
| 0.18*30 | 100 | In distribution | |
| 0.30*25 | 100 | In distribution | |
| 0.22*30 | 500 | In distribution | |
| 0.30*75 | 1,000 | In distribution | |
| 0.18*13 | 100 | In distribution | |
| 0.16*25 | 100 | In distribution | |
| 0.22*30 | 100 | In distribution | |
| 0.25*30 | 100 | In distribution | |
| 0.18*40 | 100 | In distribution | |
| 0.18*13 | 100 | In distribution | |
| 0.35*75 | 1,000 | In distribution | |
| 0.30*40 | 100 | In distribution | |
| 0.20*50 | 100 | In distribution | |
| 0.35*30 | 1,000 | In distribution | |
| 0.30*13 | 100 | In distribution | |
| 0.25*75 | 100 | In distribution | |
| 0.25*25 | 100 | In distribution | |
| 0.20*40 | 500 | In distribution | |
| 0.22*30 | 1,000 | In distribution | |
| 0.25*13 | 500 | In distribution | |
| 0.35*50 | 100 | In distribution | |
| 0.30*40 | 500 | In distribution | |
| 0.30*30 | 500 | In distribution | |
| 0.30*60 | 100 | In distribution | |
| 0.20*40 | 500 | In distribution | |
| 0.20*13 | 500 | In distribution | |
| 0.18*8 | 100 | In distribution | |
| 0.20*40 | 100 | In distribution | |
| 0.25*13 | 100 | In distribution | |
| 0.22*13 | 500 | In distribution | |
| 0.35*13 | 500 | In distribution | |
| 0.18*40 | 100 | In distribution | |
| 0.16*13 | 100 | In distribution | |
| 0.35*40 | 100 | In distribution | |
| 0.30*13 | 500 | In distribution | |
| 0.22*25 | 1,000 | In distribution | |
| 0.20*25 | 500 | In distribution | |
| 0.25*75 | 100 | In distribution | |
| 0.16*25 | 500 | In distribution | |
| 0.25*25 | 1,000 | In distribution | |
| 0.25*60 | 500 | In distribution | |
| 0.22*13 | 100 | In distribution | |
| 0.30*50 | 100 | In distribution | |
| 0.40*30 | 100 | In distribution | |
| 0.30*30 | 100 | In distribution | |
| 0.18*8 | 500 | In distribution | |
| 0.22*50 | 1,000 | In distribution | |
| 0.35*50 | 500 | In distribution | |
| 0.22*60 | 1,000 | In distribution | |
| 0.22*60 | 500 | In distribution | |
| 0.30*75 | 500 | In distribution | |
| 0.30*60 | 500 | In distribution | |
| 0.22*40 | 100 | In distribution | |
| 0.40*60 | 500 | In distribution | |
| 0.35*15 | 100 | In distribution | |
| 0.18*40 | 100 | In distribution | |
| 0.25*75 | 500 | In distribution | |
| 0.25*60 | 100 | In distribution | |
| 0.16*7 | 500 | In distribution | |
| 0.22*25 | 500 | In distribution | |
| 0.35*50 | 100 | In distribution | |
| 0.35*25 | 100 | In distribution | |
| 0.16*13 | 100 | In distribution | |
| 0.22*40 | 500 | In distribution | |
| 0.35*40 | 100 | In distribution | |
| 0.25*30 | 1,000 | In distribution | |
| 0.25*40 | 100 | In distribution | |
| 0.22*15 | 100 | In distribution | |
| 0.22*40 | 100 | In distribution | |
| 0.35*30 | 500 | In distribution | |
| 0.35*60 | 100 | In distribution | |
| 0.16*25 | 500 | In distribution | |
| 0.18*40 | 500 | In distribution | |
| 0.35*60 | 500 | In distribution | |
| 0.30*50 | 100 | In distribution | |
| 0.40*75 | 500 | In distribution | |
| 0.20*13 | 500 | In distribution | |
| 0.40*50 | 100 | In distribution | |
| 0.25*30 | 100 | In distribution | |
| 0.18*30 | 100 | In distribution | |
| 0.25*13 | 100 | In distribution | |
| 0.18*40 | 100 | In distribution | |
| 0.30*75 | 100 | In distribution | |
| 0.22*40 | 100 | In distribution | |
| 0.20*50 | 100 | In distribution | |
| 0.18*25 | 100 | In distribution | |
| 0.20*50 | 100 | In distribution | |
| 0.35*25 | 1,000 | In distribution | |
| 0.35*15 | 100 | In distribution | |
| 0.25*50 | 1,000 | In distribution | |
| 0.16*7 | 100 | In distribution | |
| 0.35*60 | 100 | In distribution | |
| 0.20*15 | 500 | In distribution | |
| 0.20*30 | 100 | In distribution | |
| 0.30*60 | 1,000 | In distribution | |
| 0.25*30 | 100 | In distribution | |
| 0.35*13 | 100 | In distribution | |
| 0.35*30 | 100 | In distribution | |
| 0.16*30 | 100 | In distribution | |
| 0.20*25 | 1,000 | In distribution | |
| 0.20*30 | 500 | In distribution | |
| 0.40*40 | 500 | In distribution | |
| 0.25*15 | 1,000 | In distribution | |
| 0.20*30 | 100 | In distribution | |
| 0.25*30 | 500 | In distribution | |
| 0.16*25 | 100 | In distribution | |
| 0.25*13 | 1,000 | In distribution | |
| 0.25*50 | 100 | In distribution | |
| 0.16*7 | 100 | In distribution | |
| 0.25*30 | 500 | In distribution | |
| 0.18*15 | 100 | In distribution | |
| 0.18*15 | 100 | In distribution | |
| 0.35*13 | 1,000 | In distribution | |
| 0.20*25 | 100 | In distribution | |
| 0.25*13 | 100 | In distribution | |
| 0.22*50 | 100 | In distribution | |
| 0.18*25 | 100 | In distribution | |
| 0.35*30 | 500 | In distribution | |
| 0.40*25 | 500 | In distribution | |
| 0.35*25 | 100 | In distribution | |
| 0.30*15 | 100 | In distribution | |
| 0.25*25 | 500 | In distribution | |
| 0.22*30 | 100 | In distribution | |
| 0.25*60 | 100 | In distribution | |
| 0.30*75 | 100 | In distribution | |
| 0.20*40 | 100 | In distribution | |
| 0.22*60 | 100 | In distribution | |
| 0.16*25 | 1,000 | In distribution | |
| 0.25*50 | 500 | In distribution | |
| 0.40*40 | 100 | In distribution | |
| 0.18*13 | 1,000 | In distribution | |
| 0.22*15 | 500 | In distribution | |
| 0.25*30 | 100 | In distribution | |
| 0.18*30 | 100 | In distribution | |
| 0.35*75 | 100 | In distribution | |
| 0.30*30 | 500 | In distribution | |
| 0.22*30 | 100 | In distribution | |
| 0.18*40 | 500 | In distribution | |
| 0.20*25 | 100 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Seirin Acupuncture Needle | Seirin Corporation | 218 |
| Tewa | Asia-MED Gmbh | 186 |
| Tewa | asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG | 184 |
| Eacu, Eaku, Zagu, Jocu | Maanshan Bond Medical Instruments Co., Ltd. | 176 |
| AcuZone | Wujiang City ShenLing Medical Device Co., Ltd. | 158 |
| Lekon | C.A.I. Industries Corp. | 129 |
| TCMzoneHuaTuo | Tcmzone, LLC | 129 |
| Carbo | Wujiang City Cloud & Dragon Medical Device Co., Ltd. | 115 |
| Carbo | Wujiang City ShenLing Medical Device Co., Ltd. | 114 |
| ACE | Wuxi Jiajian Medical Instrument Co., Ltd. | 113 |
| Silverstar | Health Body World Supply Inc. | 101 |
| Shenmen | Wujiang City ShenLing Medical Device Co., Ltd. | 89 |
Showing 12 of 184. All products under Needle, Acupuncture, Single Use
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K162566 | 2017-05-11 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.