← Product Code [MQX](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MQX) · K003010

# SPIRIT ACUPUNCTURE NEEDLE (K003010)

_United Pacific Co., Ltd. · MQX · Oct 19, 2000 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MQX/K003010

## Device Facts

- **Applicant:** United Pacific Co., Ltd.
- **Product Code:** [MQX](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MQX.md)
- **Decision Date:** Oct 19, 2000
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.5580
- **Device Class:** Class 2
- **Review Panel:** General Hospital

## Regulatory 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.

## 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.

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MQX/K003010](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MQX/K003010)

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