Skylark Device Co., Ltd.
Medical device manufacturer in Taipei, TW.
20510(k) clearances
0PMA approvals
0recalls
Device types
- GZJ Stimulator, Nerve, Transcutaneous, For Pain… 10
- IPF Stimulator, Muscle, Powered 2
- LIH Interferential Current Therapy 2
- GXY Electrode, Cutaneous 1
- EGJ Device, Iontophoresis, Other Uses 1
- GYB Media, Electroconductive 1
- IMI Ultrasonic Diathermy For Use In Applying… 1
- FLL Continuous Measurement Thermometer 1
- ILY Lamp, Infrared, Therapeutic Heating 1
510(k) clearances
| 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 |
| K946299 | PGS123 and HVS-123GZJ · Traditional | 06/26/1995SE |
| K934051 | Bio SDP (Aka Saturn SD, Glc-Iii SD & Stat-Sd)GZJ · Traditional | 07/11/1994SE |
| K930535 | IF400LIH · Traditional | 06/14/1994SE |
| K931079 | Stat-TensGZJ · Traditional | 06/09/1994SE |
| K925729 | SD-602 SD Mode 11, SD-603 SD Mod 111GZJ · Traditional | 01/22/1993SE |
| K923934 | TX-3 SDGZJ · Traditional | 10/23/1992SE |
| K923935 | SD-605 SD II ProgramGZJ · Traditional | 10/15/1992SE |
| K923298 | Micro 100,200,300, & 400 TENSGZJ · Traditional | 10/13/1992SE |
| K912643 | ElectrodeGXY · Traditional | 02/14/1992SE |
| K912642 | EMS300, EMS400, EMS8000IPF · Traditional | 12/09/1991SE |
| K912178 | Bio TENS 601, 606 and 608 (3000)GZJ · Traditional | 10/25/1991SE |