PGS123 and HVS-123
FDA 510(k) K946299 · Skylark Device Co., Ltd.
510(k) numberK946299
Submission
- Device name
- PGS123 and HVS-123
- Applicant
- Skylark Device Co., Ltd.
Taipei, TW - Received
- December 27, 1994
- Decision date
- June 26, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code GZJ
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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 |
|---|---|---|
| K990233 | ST-302 InfrarexILY · Traditional | 10/27/1999SE |
| K984506 | SD-100 Skyear ThermometerFLL · Traditional | 07/29/1999SE |
| K981449 | SD-956 Ultrasound TherapyIMI · Traditional | 12/11/1998SE |
| K983964 | Batch #6060 Conductive GelGYB · Traditional | 12/09/1998SE |
| K964437 | GB-1002 TENS with MassageGZJ · Traditional | 08/14/1998SE |
| K974585 | IF-727 Interferential StimulatorLIH · Traditional | 03/06/1998SE |
| K964434 | SD-970EMS Electrical Muscular StimulatorIPF · Traditional | 10/09/1997SE |
| K963729 | SD-610M(ALSO Known AS Standard TENS, SD-609M,SD-611M, Glc-I Standard)GZJ · Traditional | 02/13/1997SE |
| K946337 | IT-727 (Also Known AS IT-610, IT-600 and Dynaphor IIEGJ · Traditional | 12/20/1995SE |
| K934051 | Bio SDP (Aka Saturn SD, Glc-Iii SD & Stat-Sd)GZJ · Traditional | 07/11/1994SE |
Questions and answers
When was PGS123 and HVS-123 cleared by the FDA?
PGS123 and HVS-123 (K946299) received a 510(k) decision of Substantially Equivalent on June 26, 1995, 181 days after the submission was received.
What is the product code of K946299?
The FDA product code is GZJ – Stimulator, Nerve, Transcutaneous, For Pain Relief, a Class II (moderate risk) device regulated under 21 CFR 882.5890.