KHT Sooji Needle, Hand Acupuncture Needle
by American Institute of Koryo Hand Therapy
510(k) K980469
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK980469 | Date3 Apr 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- Withdrawn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
- 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, 6 Oct 2026
The KHT Sooji Needle, Hand Acupuncture Needle is a sterile, single-use acupuncture needle designed for hand acupuncture. It is used by qualified acupuncture practitioners to pierce the skin during acupuncture therapy.
The device is supplied in a sterile condition and is intended for single use only. It is regulated under FDA 510(k) clearance K980469 and classified as a Class II medical device under regulation number 880.5580.
Other devices from American Institute of Koryo Hand Therapy
Questions
AI-generated answers, 6 Oct 2026
What is the KHT Sooji Needle used for?
The KHT Sooji Needle is used by qualified acupuncture practitioners to pierce the skin during hand acupuncture therapy, as it is specifically designed for this application.
How is the KHT Sooji Needle supplied and is it reusable?
The device is supplied in a sterile condition and is intended for single use only, meaning it should not be reused after initial application to maintain sterility and safety.
What regulatory pathway was used for the KHT Sooji Needle?
The KHT Sooji Needle is regulated under FDA 510(k) clearance K980469 and is classified as a Class II medical device under regulation number 880.5580.