HWA-TO ACUPUNCTURE NEEDLES

K963299 · Lhasa Medical, Inc. · MQX · Sep 30, 1996 · General Hospital

Device Facts

• Record ID: K963299
• Device Name: HWA-TO ACUPUNCTURE NEEDLES
• Applicant: Lhasa Medical, Inc.
• Product Code: MQX · General Hospital
• Decision Date: Sep 30, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5580
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Acupuncture needles are defined as devices intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.

Device Story

Hwa-To acupuncture needle; sterile, single-use device; intended for skin piercing during acupuncture practice. Manufactured in China since 1986; imported for US distribution. Device functions as manual tool for acupuncture therapy; no electronic or automated components. Used by qualified practitioners in clinical settings. Benefits include sterile, single-use design to mitigate infection risks associated with reusable needles.

Clinical Evidence

No clinical data provided. Safety and effectiveness supported by historical usage data since 1986 and equivalence to predicate acupuncture needles.

Technological Characteristics

Sterile, single-use acupuncture needle. Manual device; no energy source or software. Materials and specifications consistent with general acupuncture needle standards.

Indications for Use

Indicated for use by qualified practitioners for the practice of acupuncture.

Regulatory Classification

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.

Submission Summary (Full Text)

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LHASA MEDICAL, INC.
K963299
234 Libbey Parkway, Weymouth, MA 02189 [phone] (fax: [phone])
August 20, 1996
SEP 30 1996

# PRE-MARKET NOTIFICATION
## 510(k) SUMMARY
(As Required by 21 CFR 807.93)

Acupuncture needles are defined as devices intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.

Acupuncture needles have been used for the general practice of acupuncture in the United States for over 30 years. Since this time, we are not aware of any serious or life threatening accidents involving acupuncture needles.

Acupuncture needles which were sold through commercial interstate distribution prior to May 28, 1976 were non-sterile, reusable acupuncture needles. Acupuncture needles which are currently being marketed through interstate distribution (ie, 1996) offer greater safety since they are sterile, single use only acupuncture needles.

The subject of this 510(k) application - the Hwa-To acupuncture needle - is a sterile, single use only acupuncture needle. The Hwa-To acupuncture needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture.

The Hwa-To brand acupuncture needle was first manufactured in China in 1986 and has been imported and sold through interstate commerce in the USA under the FDA labeling restrictions of: "Caution: Investigational device limited by U.S. law to investigational use". Since 1986, no accidents or device failure claims have been reported as a result of using the Hwa-To brand acupuncture needle.

In conclusion, based on the information provided with this 510(k) application, the Hwa-To acupuncture needle meets the criteria for 510(k) acceptance. The Hwa-To needle is equivalent to acupuncture needles which were in commercial distribution prior to May 28, 1976. Also, the Hwa-To needle is equivalent to other acupuncture needles which are currently being sold through interstate commerce.

Kyung Soon Riihimaki, President
Date: 8-20-96

Premarket Notification (510(k) Number):