Low Back Strip (or) K-Back
FDA 510(k) K912381 · Katecho, Inc.
510(k) numberK912381
Submission
- Device name
- Low Back Strip (or) K-Back
- Applicant
- Katecho, Inc.
Des Moines, IA, US - Received
- May 29, 1991
- Decision date
- January 30, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K012404 | K-Defib/Pace Adult Electrode, Model KDP-85DRO · Traditional | 10/12/2001SE |
| K010543 | KM-30 TENS ElectrodeGXY · Traditional | 05/23/2001SE |
| K003228 | K-Defib/Pace Multifuction Pediatric Electrode, Model KDP-70AMKJ · Traditional | 12/14/2000SE |
| K002806 | K-Defib/Pace, Model KDP-60AMKJ · Traditional | 11/21/2000SE |
| K000870 | KM-10 TENS ElectrodeGXY · Traditional | 11/07/2000SE |
| K993745 | K-Defib/Pace Adult Electrode, Model KDP-80MKJ · Traditional | 02/03/2000SE |
| K991007 | K-Defib/Pace Radiolucent Adult Electrode, Model KRT-60MKJ · Traditional | 08/23/1999SE |
| K981737 | K-Defib/Pace Adult Electrode Model Number KDP-60MKJ · Traditional | 12/09/1998SE |
| K954504 | K-Defib/Pace Pediatric ElectrodeMKJ · Traditional | 11/17/1995SE |
| K934692 | K-Defib/Pace Pediatric ElectrodeMKJ · Traditional | 01/24/1995SE |
Questions and answers
When was Low Back Strip (or) K-Back cleared by the FDA?
Low Back Strip (or) K-Back (K912381) received a 510(k) decision of Substantially Equivalent on January 30, 1992, 246 days after the submission was received.
What is the product code of K912381?
The FDA product code is GZJ – Stimulator, Nerve, Transcutaneous, For Pain Relief, a Class II (moderate risk) device regulated under 21 CFR 882.5890.