Stimtech SD Patient 6089 #78-8050
FDA 510(k) K844213 · Codman & Shurtleff, Inc.
510(k) numberK844213
Submission
- Device name
- Stimtech SD Patient 6089 #78-8050
- Applicant
- Codman & Shurtleff, Inc.
Randolph, MA, US - Received
- October 31, 1984
- Decision date
- January 10, 1985
- 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 |
|---|---|---|
| K193380 | CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing SetNRY · Traditional | 07/20/2020SE |
| K191237 | CERENOVUS Large Bore CatheterDQY · Traditional | 11/08/2019SE |
| K173192 | CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP…GWM · Special | 11/08/2017SE |
| K172537 | Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System…JXG · Traditional | 10/16/2017SE |
| K172022 | CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)JXG · Traditional | 10/03/2017SE |
| K171862 | GALAXY G3 Mini Microcoil Delivery SystemHCG · Traditional | 09/25/2017SE |
| K171747 | MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch…HCG · Special | 07/14/2017SE |
| K171653 | YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back UpDQY · Special | 07/03/2017SE |
| K162563 | YOGA MicrocatheterDQY · Special | 01/05/2017SE |
| K162437 | Codman EDS3 CSF External Drainage SystemJXG · Traditional | 10/28/2016SE |
Questions and answers
When was Stimtech SD Patient 6089 #78-8050 cleared by the FDA?
Stimtech SD Patient 6089 #78-8050 (K844213) received a 510(k) decision of Substantially Equivalent on January 10, 1985, 71 days after the submission was received.
What is the product code of K844213?
The FDA product code is GZJ – Stimulator, Nerve, Transcutaneous, For Pain Relief, a Class II (moderate risk) device regulated under 21 CFR 882.5890.