JIAJIAN ELECTRO-ACUPUNCTURE STIMULATORS

• K Number: K122812
• Device Name: JIAJIAN ELECTRO-ACUPUNCTURE STIMULATORS
• Manufacturer: WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD.
• Date Cleared: 2013-04-11 ( 210 days)
• Product Code: BWK
• Regulation Number: N/A

Intended Use

Jiajian® Electro-acupuncture Stimulator, Model WQ-10D1 and WQ-6F are electro-acupuncture stimulator devices, which are indicated for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

Device Description

Jiajian® Electro-acupuncture Stimulator, Model WQ-10D1, is a battery powered instrument with 3 channel outputs for acupuncture needle stimulation. The predicate device is ES-130, K081943. The output frequency and intensity for stimulation are adjustable. The stimulation time can be set. The 3 channels can output stimulation simultaneously. The device is powered by DC 9V battery, Type 6F22. When the battery has insufficient voltage (<8.5V), the light goes out. The user should replace battery. WQ-10D1 does not equip with acupuncture needles. The practitioners should select 510(k) cleared needles (with minimum diameter of 0.30mm and insertion depth of 15mm) for use. Jiajian® Electro-acupuncture Stimulator, Model WQ-6F, is an electro-acupuncture device, composed of a main unit and seven separate lead wires which represent 7 output channels. 4 output channels are grouped in Section A and 3 output channels are grouped in Section B. Section A and B have separate intensity and frequency adjusting knobs. The 4 channels in Section A can output waveforms simultaneously, and the 3 channels in Section B can output waveforms simultaneously but Section A and Section B can not output waveforms simultaneously. The main unit is powered by DC4.5V battery (three No 1 battery, Size "D"). When the battery has insufficient voltage (<4.1V), the light goes out. The user should replace battery. WQ-6F does not equip with acupuncture needles. The practitioners should select 510(k) cleared needles (with minimum diameter of 0.30mm and insertion depth of 15mm) for use. The predicate device of WQ-6F is ES-130, K081943.

Predicate Devices

K081943

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on basic electrical stimulation parameters (frequency, intensity, time) and battery power, with no mention of AI, ML, or any adaptive or learning capabilities.

Therapeutic

Yes.
The device is used to stimulate acupuncture needles, which falls under the practice of acupuncture by qualified practitioners, indicating a therapeutic purpose.

Diagnostic

No

The device is described as an "electro-acupuncture stimulator" used to provide stimulation for acupuncture, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description explicitly details physical hardware components such as battery-powered instruments, output channels, lead wires, and adjusting knobs, indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
• Device Function: The Jiajian® Electro-acupuncture Stimulator is used to apply electrical stimulation to the body through acupuncture needles. It is a therapeutic device used in the practice of acupuncture.
• Intended Use: The intended use clearly states it's for "use in the practice of acupuncture by qualified practitioners of acupuncture". This involves direct application to the patient's body, not testing of specimens.

Therefore, based on its function and intended use, the Jiajian® Electro-acupuncture Stimulator is a therapeutic device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Jiajian® Electro-acupuncture Stimulator, Model WQ-10D1 and WQ-6F are electro-acupuncture stimulator devices, which are indicated for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

Product codes (comma separated list FDA assigned to the subject device)

BWK

Device Description

Jiajian® Electro-acupuncture Stimulator, Model WQ-10D1, is a battery powered instrument with 3 channel outputs for acupuncture needle stimulation. The output frequency and intensity for stimulation are adjustable. The stimulation time can be set. The 3 channels can output stimulation simultaneously. The device is powered by DC 9V battery, Type 6F22. When the battery has insufficient voltage (

Regulation Number and Section

N/A

Summary

0

Wuxi Jiajian Medical Instrument Co., Ltd

Qinghong Rd., Ehu Town, Xishan District, Wuxi, Jiangsu, China 214116

Section 5

510(k) Summary

[As required by 21 CFR 807.92]

1. Submission Information
510(k) Number:	K122812
Date:	Feb 27th, 2013
Type of 510(k) Submission:	Traditional
Basis for 510(k) Submission:	New device
Submitter/Manufacturer:	Wuxi Jiajian Medical Instrument Co., Ltd
Qinghong Rd., Ehu Town, Xishan District, Wuxi, China 214116
Contactor:	Doris Dong
[Consultant, from Shanghai CV Technology Co., Ltd.]
Add.: Room 1706 Yuesha, No. 128 Songle Rd., Songjiang, Shanghai, China 201600
E-mail: [e-mail]
Tel: [phone]
Fax: [phone]

2. Device Description

.

| Proprietary Name: | Jiajian® Electro-acupuncture Stimulators
(Model: WQ-10D1 and WQ-6F) |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Electro-acupuncture Device |
| Classification Name: | Stimulator, Electro-acupuncture |
| Regulation Number: | Unclassified |
| Review Panel: | Neurology |
| Product Code: | BWK |
| Device Class: | Unclassified, 510(k) |
| Device Description: | Jiajian® Electro-acupuncture Stimulator, Model WQ-10D1, is a battery
powered instrument with 3 channel outputs for acupuncture needle
stimulation. The predicate device is ES-130, K081943.
The output frequency and intensity for stimulation are adjustable. The
stimulation time can be set. The 3 channels can output stimulation
simultaneously.
The device is powered by DC 9V battery, Type 6F22. When the battery
has insufficient voltage (