Millennia Acupuncture Needle
by United Pacific Co., Ltd. 510(k)
Active
510(k) K001718
Overview
The Millennia Acupuncture Needle is a single-use acupuncture needle, classified as a Class II medical device under FDA regulations. Designed for traditional acupuncture practices, it is intended for insertion into specific acupuncture points on the body to stimulate healing and relieve symptoms. These needles are manufactured from stainless steel and follow standard acupuncture needle specifications, ensuring precision and safety for clinical use.
Supplied in sterile, single-use packaging, the Millennia Acupuncture Needle is intended for use in clinical settings such as general hospitals. Each needle is packaged individually to maintain sterility, and the device is regulated under FDA 510(k) clearance (K001718) with a classification of MQX. The needles are available in various lengths, including 6-inch variants, with each box containing 100 needles. The device complies with FDA regulations for acupuncture needles and is exempt from certain premarket notification procedures under specific conditions.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK001718 | Date21 Jun 2000 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 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
Other devices from United Pacific Co., Ltd.
Questions
What is the Millennia Acupuncture Needle used for?
The Millennia Acupuncture Needle is designed for traditional acupuncture practices, intended to stimulate healing and relieve symptoms by insertion into specific acupuncture points on the body. It follows standard acupuncture needle specifications to ensure precision and safety in clinical settings like general hospitals.
How is the Millennia Acupuncture Needle supplied, and what ensures its sterility?
The Millennia Acupuncture Needle is supplied in sterile, single-use packaging, with each needle individually wrapped to maintain sterility. This packaging prevents contamination and ensures safe, one-time clinical use, adhering to FDA regulations for acupuncture needles.
Are the Millennia Acupuncture Needles reusable, or are they intended for single-use?
The Millennia Acupuncture Needles are explicitly designed for single-use only. This design choice aligns with FDA guidelines for acupuncture needles to minimize infection risks and ensure patient safety, as reuse could compromise sterility and integrity.
What lengths and quantities are available for the Millennia Acupuncture Needle?
The Millennia Acupuncture Needle is available in various lengths, including a 6-inch variant. Each box contains 100 individually sterile needles, providing flexibility for clinical practices requiring different quantities or sizes.
How should the Millennia Acupuncture Needle be stored to preserve its sterility?
The Millennia Acupuncture Needle should be stored in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Proper storage ensures the needle remains sterile and intact until use, maintaining compliance with FDA standards for single-use medical devices.