# K052846: Tewa CJ-Type, PJ-Type, CB-Type and PB-Type Acupuncture Needles for Single Use

- Pathway: 510(k) (Traditional)
- Applicant: Maanshan Medical Instruments Co., Ltd.
- Decided: Dec 22, 2005 after 76 days
- Product code: MQX (Needle, Acupuncture, Single Use)
- Device class: 2
- Regulation: 21 CFR 880.5580
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The 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.

Source page: https://510kreport.com/device/K052846
Methodology: https://510kreport.com/methodology