Hepax (TENS)
FDA 510(k) K882154 · Avl Scientific Corp.
510(k) numberK882154
Submission
- Device name
- Hepax (TENS)
- Applicant
- Avl Scientific Corp.
Roswell, GA, US - Received
- May 23, 1988
- Decision date
- September 30, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code GZJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252712 | STIMPOD NMS460 Nerve StimulatorGZJ · Traditional | Algiamed Technologies USA, Inc. | 05/28/2026SE |
| K252767 | actiTENS miniGZJ · Traditional | Sublimed | 01/16/2026SE |
| K252236 | CP Relief Wand Rx - TENS/NMESGZJ · Special | N & C Holdings, LLC | 08/15/2025SE |
| K232441 | Unipro (K-UNIPRO-US)GZJ · Traditional | Tenscare, Ltd. | 08/30/2024SE |
| K241228 | TENSWaveGZJ · Abbreviated | Zynex Medical Officer | 08/27/2024SE |
| K233046 | Electrical Neuromuscular Stimulator, Cure TrioGZJ · Traditional | Oriental Inspiration Limited | 04/19/2024SE |
| K222879 | Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)GZJ · Traditional | Wuxi Jiajian Medical Instrument Co., Ltd. | 01/24/2023SE |
| K212618 | iRelieve Microcurrent Pain Relief SystemGZJ · Traditional | Fast Track Technologies, Inc. | 09/14/2022SE |
| K213802 | StimOnTM Pain Relief System (GM2439)GZJ · Traditional | Gimer Medical Co., Ltd. | 08/26/2022SE |
| K220578 | Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)GZJ · Traditional | Bozhou Rongjian Medical Appliance Co., Ltd. | 05/25/2022SE |
More from Bozhou Rongjian Medical Appliance Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K001632 | Opti-Check Plus Multi-Analyte Control, Model HC7009JJY · Traditional | 06/19/2000SE |
| K000103 | Avl Opti R AnalyzerCHL · Traditional | 03/20/2000SE |
| K993837 | Avl Opti Critical Care AnalyzerCGA · Traditional | 12/16/1999SE |
| K990092 | Avl Omni Modular AnalyzerCHL · Traditional | 01/29/1999SE |
| K984299 | Avl Opti Critical Care AnalyzerJFP · Traditional | 12/11/1998SE |
| K974784 | Avl Opti Critical Care AnalyzerCEM · Traditional | 02/24/1998SE |
| K974822 | Avl Opti-Check Ph/ Blood Gas/ Electrolyte/Thb/ SO2 ControlJJY · Traditional | 01/22/1998SE |
| K972733 | Avl Omni AnalyzerCGA · Traditional | 09/09/1997SE |
| K972673 | Avl 9181 Electrolyte AnalyzerJFP · Traditional | 08/20/1997SE |
| K963964 | Avl Compact 3 Ph/Blood Gas AnalyzerCHL · Traditional | 11/29/1996SE |
Questions and answers
When was Hepax (TENS) cleared by the FDA?
Hepax (TENS) (K882154) received a 510(k) decision of Substantially Equivalent on September 30, 1988, 130 days after the submission was received.
What is the product code of K882154?
The FDA product code is GZJ – Stimulator, Nerve, Transcutaneous, For Pain Relief, a Class II (moderate risk) device regulated under 21 CFR 882.5890.