# K974122: Acupuncture Needle Under the Brand Name Hwato and Huaxia

- Pathway: 510(k) (Traditional)
- Applicant: Scientific Health Care
- Decided: Jan 22, 1998 after 83 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
HWATO & HUAXIA two brand names-- HWATO and HUAXIA acupuncture needles are used to pierce skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.

Source page: https://510kreport.com/device/K974122
Methodology: https://510kreport.com/methodology