Neuromedics Orions #660-01
FDA 510(k) K822600 · Intermedics, Inc.
510(k) numberK822600
Submission
- Device name
- Neuromedics Orions #660-01
- Applicant
- Intermedics, Inc.
Mchenry, IL, US - Received
- August 27, 1982
- Decision date
- September 24, 1982
- 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 |
|---|---|---|
| K954610 | Model 430-07 Endocardial Pacing LeadDTB · Traditional | 12/16/1996PT |
| K955122 | Intermedics Model 436-07 Bipolar & Model 437-07 Unipolar Implantable Endocardial Pacing…DTB · Traditional | 11/04/1996ST |
| K962174 | Biplr Im En Pac Leads (430-07,432-03,436-02 & 07, 438-05 & 07)DTB · Traditional | 08/21/1996ST |
| K955550 | Cardifix Ez Bipolar/Unipolar Endocardial Pacing LeadDTB · Traditional | 06/19/1996ST |
| K960281 | Implantable Pacing Leads/Implantable Accessory/Non-Implantable AccessoryDTB · Traditional | 06/18/1996ST |
| K954719 | Intermedics Model 430-07 Bipolar Implantable Endocardial Pacing LeadDTB · Traditional | 02/27/1996ST |
| K933278 | Intermedics Triangle Chest Probe Model 526-04KRG · Traditional | 03/15/1995SE |
| K922042 | Cardifix Endocardial Pacing LeadDTB · Traditional | 04/29/1993SESP |
| K922972 | Models 438-05 and 435-05 Implantable Pacing LeadDTB · Traditional | 01/22/1993SESP |
| K920530 | Intermedics Model 366-15 VS 1 Header PlugDXY · Traditional | 03/17/1992SE |
Questions and answers
When was Neuromedics Orions #660-01 cleared by the FDA?
Neuromedics Orions #660-01 (K822600) received a 510(k) decision of Substantially Equivalent on September 24, 1982, 28 days after the submission was received.
What is the product code of K822600?
The FDA product code is GZJ – Stimulator, Nerve, Transcutaneous, For Pain Relief, a Class II (moderate risk) device regulated under 21 CFR 882.5890.