Avazzia
Convenience kit with Avazzia Life Pinnacle device, conductive pads, Y electrode accessory, brush electrode accessory, lead wires, batteries, instruction manual and carry case.
32manufacturers in China registered for this device type
29catalogue numbers in this listing
2510(k) clearances naming this product code
4recalls on this code
Who Else Makes It
Concentrated in Guangdong (23), Jiangsu (2), Beijing (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| JKH Health Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 22 |
| Shenzhen Jie Zhong Lian Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| ATL Technology DG,Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Hang Yik Electronics Plastics & Mold (ShenZhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 2 |
| Shenzhen Zifound Infonet Technology Co., Ltd. | Shenzhen, Guandong | Guangdong | Contract manufacturer | 2 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Beijing Choice Electronic Technololgy Co., Ltd. | Beijing | Beijing | Repacker / relabeller | 30 |
| Hong Qiangxing (Shen Zhen) Electronics Limited | Shenzhen | Guangdong | Contract manufacturer | 19 |
| Shenzhen Dongdixin Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| Guangzhou Xinbo Electronic Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 18 |
| Drtv Asia Ltd | Panyu Guangzhou | Guangdong | Specification developer | 16 |
| Hebei Tuosite Technology Co., Ltd. | Shijiazhuang | Hebei | Manufacturer | 14 |
Showing 12 of 32. All 32 manufacturers in China registered for Stimulator, Nerve, Transcutaneous, For Pain Relief
Record
| Listed by | Avazzia, Inc., United States |
|---|---|
| FDA product code | GZJ |
| Device type | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5890 |
| Establishment | Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-23 |
| Record revised | 2026-04-27 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | serial number |
| Distribution end date | 2026-03-31 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A4-RS-K | In distribution | |
| A4-PS-K | In distribution | |
| A4-PS | In distribution | |
| A4-BP-K-Y | In distribution | |
| AA-EC | In distribution | |
| A4-PL-K | In distribution | |
| A4-UL | In distribution | |
| A4-BP | In distribution | |
| AA-Y175 | In distribution | |
| A4-TP | In distribution | |
| AA-EP | In distribution | |
| A4-AP | In distribution | |
| A4-AE-K-Y | In distribution | |
| A4-AE | In distribution | |
| AA-FE | In distribution | |
| A4-PL | In distribution | |
| A4-BP-K | In distribution | |
| A4-RS | In distribution | |
| A4-RS-K-Y | In distribution | |
| A4-UL-K | In distribution | |
| AA-CC | In distribution | |
| A4-AP-K | In distribution | |
| A4-TB2 | In distribution | |
| A4-AB-K-Y | Withdrawn | |
| A4-AB-K | Withdrawn | |
| A4-TB | Withdrawn | |
| A4-AB | Withdrawn | |
| A4-AL | Withdrawn | |
| A4-EN-K | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| GEM-Stim | Gemore Technology Co., Ltd. | 66 |
| Belifu | Hong Qiangxing (Shen Zhen) Electronics Limited | 55 |
| Neocarbon | Hong Qiangxing (Shen Zhen) Electronics Limited | 38 |
| Domas | Hong Qiangxing (Shen Zhen) Electronics Limited | 30 |
| NeuroMD | Hong Qiangxing (Shen Zhen) Electronics Limited | 24 |
| Mastogo | Hong Qiangxing (Shen Zhen) Electronics Limited | 18 |
| EmeTerm | WAT Medical Technology Inc. | 17 |
| Stimease | Hong Qiangxing (Shen Zhen) Electronics Limited | 15 |
| Xpoint | Hong Qiangxing (Shen Zhen) Electronics Limited | 15 |
| Globus | Domino SRL | 13 |
| Omega | Hong Qiangxing (Shen Zhen) Electronics Limited | 12 |
| Roscoe Medical | Drive DeVilbiss Healthcare | 12 |
Showing 12 of 358. All products under Stimulator, Nerve, Transcutaneous, For Pain Relief
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K123099 | 2014-05-23 |
| K062641 | 2007-04-30 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2007-06-29 | Not classified | Other | Plastic Cases may crack due to manufacturing by the supplier not meeting specifications | 134 units. | 2008-04-04 |
| 2007-06-29 | Not classified | Other | Plastic Cases may crack due to manufacturing by the supplier not meeting specifications | 8 units | 2008-04-04 |
| 2007-06-29 | Not classified | Other | Plastic Cases may crack due to manufacturing by the supplier not meeting specifications | 75 units | 2008-04-04 |
| 2007-06-29 | Not classified | Other | Plastic Cases may crack due to manufacturing by the supplier not meeting specifications | 61 units | 2008-04-04 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.