Hwato and Huaxia Acupuncture Needle
510(k) K974122
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK974122 | Date22 Jan 1998 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Acupuncture Needle Under the Brand Name Hwato and Huaxia
- 510(k) Number
- FDA Product Code
- MQX
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5580
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is an acupuncture needle, a sterile, single-use medical instrument designed for piercing the skin during acupuncture procedures. It adheres to the FDA classification of Needle, Acupuncture, Single Use and is intended for use by qualified practitioners in the practice of acupuncture as defined by state regulations. The needles are manufactured under the brand names Hwato and Huaxia, ensuring compliance with acupuncture standards for precision and safety.
The Hwato and Huaxia Acupuncture Needle is supplied as a sterile, single-use product, requiring no reprocessing. It is classified under FDA regulation 880.5580 and holds a 510(k) clearance (K974122) with a decision of Substantially Equivalent (SESE). Needles are available in multiple reference codes (e.g., 3005417950, 3033906329) and are intended for use in general hospital settings. Storage and handling must comply with sterile medical device protocols to maintain integrity.
Questions
AI-generated answers, 1 Oct 2026
What are the Hwato and Huaxia acupuncture needles designed for?
These needles are sterile, single-use instruments specifically designed for piercing the skin during acupuncture procedures. They comply with FDA standards for precision and safety, ensuring they are suitable for use by qualified practitioners in licensed acupuncture practices as defined by state regulations.
How are the Hwato and Huaxia acupuncture needles supplied, and do they require reprocessing?
The needles are supplied as sterile, single-use products, meaning they are intended for one-time use only and do not require reprocessing. This design minimizes infection risks and ensures compliance with sterile medical device protocols.
Are there different models or reference codes for these acupuncture needles?
Yes, the Hwato and Huaxia acupuncture needles come in multiple reference codes, including but not limited to 3005417950, 3033906329, and others listed under FDA registration. These variations allow practitioners to select the appropriate needle size or type for their specific acupuncture needs.
What storage and handling guidelines should be followed for these needles?
Since these needles are sterile and single-use, they must be stored and handled according to strict sterile medical device protocols. This includes keeping them in their original packaging until use, protecting them from contamination, and adhering to manufacturer guidelines to maintain their integrity and sterility.
What regulatory clearance does the Hwato and Huaxia acupuncture needle hold?
The Hwato and Huaxia acupuncture needles hold an FDA 510(k) clearance (K974122) under the classification *Needle, Acupuncture, Single Use* with a decision of *Substantially Equivalent (SESE)*. This clearance confirms their compliance with FDA regulations for use in general hospital settings.