Select TENS, Model 4600S
FDA 510(k) K061650 · Empi
510(k) numberK061650
Submission
- Device name
- Select TENS, Model 4600S
- Applicant
- Empi
St. Paul, MN, US - Received
- June 13, 2006
- Decision date
- January 22, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| 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 |
|---|---|---|
| K093324 | Empi ContinuumIPF · Traditional | 03/05/2010SE |
| K090922 | Empi Active Transcutaneous Nerve StimulatorGZJ · Special | 06/05/2009SE |
| K072946 | Hybresis Iontophoresis Drug Delivery SystemEGJ · Special | 11/16/2007SE |
| K070427 | Dupel Transport Iontophoresis SystemEGJ · Traditional | 05/14/2007SE |
| K041920 | Infinity Plus Electrotherapy SystemIPF · Traditional | 01/21/2005SE |
| K042057 | Infinity Electrotherapy SystemLIH · Traditional | 12/17/2004SE |
| K030395 | Empi Action Patch Iontophoresis SystemEGJ · Traditional | 04/08/2003SE |
| K021100 | 300 PV Complete Electrotherapy SystemIPF · Traditional | 06/18/2002SE |
| K991991 | Dupel Iontophoresis SystemEGJ · Traditional | 09/10/1999SE |
| K983484 | Dupel B.L.U.E. Small Iontophoresis ElectrodeEGJ · Traditional | 12/28/1998SE |
Questions and answers
When was Select TENS, Model 4600S cleared by the FDA?
Select TENS, Model 4600S (K061650) received a 510(k) decision of Substantially Equivalent on January 22, 2007, 223 days after the submission was received.
What is the product code of K061650?
The FDA product code is GZJ – Stimulator, Nerve, Transcutaneous, For Pain Relief, a Class II (moderate risk) device regulated under 21 CFR 882.5890.