Trans Elec Nerve Stim/Muscle Stim Elec W/Poly Gel
FDA 510(k) K914871 · Labeltape Meditect, Inc.
510(k) numberK914871
Submission
- Device name
- Trans Elec Nerve Stim/Muscle Stim Elec W/Poly Gel
- Applicant
- Labeltape Meditect, Inc.
Grand Rapids, MI, US - Received
- October 29, 1991
- Decision date
- December 18, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K951328 | Lmi Medical, Electrode, Electrosurgical, Disposable Dispersive Electrode with CordGEI · Traditional | 04/25/1995SE |
| K915333 | Electrode Using Promeon RG-60 Series GelGXY · Traditional | 01/14/1992SE |
| K912979 | Hemawipe System, the Civilized Test, ModificationKHE · Traditional | 10/04/1991SE |
| K902738 | Electro Blue ECG Electrode-Pediatric ClothDRX · Traditional | 09/04/1990SE |
| K902719 | Spect.E.N.S. Repostion.-E Foam Pin Type TENS ElectGXY · Traditional | 07/19/1990SE |
| K900656 | Spec T.E.N.S. Prewired Repositionable TENS Elect.GXY · Traditional | 03/01/1990SE |
| K896844 | Babe-Ease Neonatal Cloth ECG ElectrodeGXY · Traditional | 02/12/1990SE |
| K896936 | L.A.S.P. Lumbar and Sacral Pad, Reposition. SnapGXY · Traditional | 01/22/1990SE |
| K894991 | Electro Blue ECG Elect. Foam, Silver/Silver Chlo.DRX · Traditional | 10/26/1989SE |
| K894462 | Care Disp. Diag. Electrodes, Silver/SilverDRX · Traditional | 10/12/1989SE |
Questions and answers
When was Trans Elec Nerve Stim/Muscle Stim Elec W/Poly Gel cleared by the FDA?
Trans Elec Nerve Stim/Muscle Stim Elec W/Poly Gel (K914871) received a 510(k) decision of Substantially Equivalent on December 18, 1991, 50 days after the submission was received.
What is the product code of K914871?
The FDA product code is GZJ – Stimulator, Nerve, Transcutaneous, For Pain Relief, a Class II (moderate risk) device regulated under 21 CFR 882.5890.