Home Microcurrent HMC
FDA 510(k) K935132 · Medical Devices, Inc.
510(k) numberK935132
Submission
- Device name
- Home Microcurrent HMC
- Applicant
- Medical Devices, Inc.
St. Paul, MN, US - Received
- October 28, 1993
- Decision date
- March 14, 1994
- 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 |
|---|---|---|
| K131719 | Ophthalmoscopes Diagnostic Instrument KitsHLJ · Traditional | 10/30/2013SE |
| K002280 | Pad Pro Pediatric Electrode, Model Pad Pro 2602MKJ · Traditional | 02/05/2001SE |
| K930084 | Micro-ArthroscopeHRX · Traditional | 09/01/1995SN |
| K943126 | ElectroflexGXY · Traditional | 12/05/1994SE |
| K940012 | Smartbrace ElectrodeGXY · Traditional | 12/05/1994SE |
| K934619 | FlexmateGZJ · Traditional | 02/23/1994SE |
| K924897 | Xenon Endoscopic Illuminator, Model XEI-300GCT · Traditional | 07/06/1993SE |
| K930053 | Video Camera W/ Electronic Shutter Model VCE-10FWF · Traditional | 05/17/1993SE |
| K923914 | If-Ii (TM), Model 7200IPF · Traditional | 11/06/1992SE |
| K920071 | Meditron Automatic Electronic Insuff. Model AEI-15GEI · Traditional | 07/21/1992SE |
Questions and answers
When was Home Microcurrent HMC cleared by the FDA?
Home Microcurrent HMC (K935132) received a 510(k) decision of Substantially Equivalent on March 14, 1994, 137 days after the submission was received.
What is the product code of K935132?
The FDA product code is GZJ – Stimulator, Nerve, Transcutaneous, For Pain Relief, a Class II (moderate risk) device regulated under 21 CFR 882.5890.