EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR, ACUKING, Myotech Dry, Red Coral Premium, Red Coral J-Type, Red Coral Natural

• K Number: K150903
• Device Name: EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR, ACUKING, Myotech Dry, Red Coral Premium, Red Coral J-Type, Red Coral Natural
• Manufacturer: MAANSHAN BOND MEDICAL INSTRUMENTS CO., LTD.
• Date Cleared: 2015-07-15 ( 103 days)
• Product Code: MQX
• Regulation Number: 880.5580
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A

Intended 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 attached to the needle to facilitate the deliyery of acupuncture treatment.

Device Description

The device consists of a solid, stainless steel needle. The device may have attached to the needle to facilitate the deliyery of acupuncture treatment.

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for several brands of acupuncture needles. It does not contain information about the acceptance criteria or a study proving that an AI device meets such criteria. Therefore, I cannot provide the requested information based on the given text.

The document discusses:

• Device Name: Eacu, Zagu, Jocu, Eaku, Balance, Tempo, Acuzone, Smart, Prime, Acuking, Myotech Dry, Red Coral Premium, Red Coral J-type, Red Coral Natural Acupuncture Needles
• Regulation Number: 21 CFR 880.5580
• Regulation Name: Acupuncture Needle
• Regulatory Class: II
• Product Code: MQX
• 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 attached to the needle to facilitate the delivery of acupuncture treatment.

There is no mention of any AI device, performance criteria, study data, sample sizes, expert ground truth, or comparative effectiveness studies.

Regulation Number and Section

§ 880.5580 Acupuncture needle.

(a)
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.(b)
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.