TIANXIE

Needle, Acupuncture, Single Use

SUZHOU TIANYI ACUPUNCTURE INSTRUMENTS CO., LTD.

The following data is part of a premarket notification filed by Suzhou Tianyi Acupuncture Instruments Co., Ltd. with the FDA for Tianxie.

Pre-market Notification Details

• Device ID: K003748
• 510k Number: K003748
• Device Name: TIANXIE
• Classification: Needle, Acupuncture, Single Use
• Applicant: SUZHOU TIANYI ACUPUNCTURE INSTRUMENTS CO., LTD. 1491 BAKER ST. Costa Mesa, CA 92626
• Contact: Henry Woo
• Correspondent: Henry Woo; SUZHOU TIANYI ACUPUNCTURE INSTRUMENTS CO., LTD. 1491 BAKER ST. Costa Mesa, CA 92626
• Product Code: MQX
• CFR Regulation Number: 880.5580 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-12-04
• Decision Date: 2001-01-26

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
18437016482282	K003748	000
18437016482480	K003748	000
18437016482497	K003748	000
18437016482503	K003748	000
18437016482510	K003748	000
18437016482527	K003748	000
18437016482534	K003748	000
18437016482558	K003748	000
18437016482565	K003748	000
18437016482572	K003748	000
18437016482589	K003748	000
18437016482473	K003748	000
18437016482466	K003748	000
18437016482459	K003748	000
18437016482299	K003748	000
18437016482305	K003748	000
18437016482312	K003748	000
18437016482329	K003748	000
18437016482336	K003748	000
18437016482404	K003748	000
18437016482411	K003748	000
18437016482428	K003748	000
18437016482435	K003748	000
18437016482442	K003748	000
18437016482596	K003748	000
18437016482602	K003748	000
18437016482619	K003748	000
08437016482117	K003748	000
08437016482124	K003748	000
08437016482131	K003748	000
08437016482148	K003748	000
08437016482155	K003748	000
08437016482162	K003748	000
08437016482186	K003748	000
08437016482193	K003748	000
08437016482544	K003748	000
08437016482841	K003748	000
08437016482100	K003748	000
08437016482094	K003748	000
08437016482087	K003748	000
18437016482626	K003748	000
18437016482633	K003748	000
18437016482640	K003748	000
08437016482018	K003748	000
08437016482025	K003748	000
08437016482032	K003748	000
08437016482049	K003748	000
08437016482056	K003748	000
08437016482063	K003748	000
08437016482070	K003748	000
08437016482995	K003748	000