# Skylark Device Co., Ltd.

- Location (FDA's records): Taipei, Taiwan, R.O.C., TW
- FDA decisions: 20 (1991–1999): 20 510(k) clearances
- Product codes: GZJ (10), LIH (2), IPF (2), GYB (1), ILY (1), EGJ (1), FLL (1), GXY (1), IMI (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 12 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Gemore Technology Co, Ltd.: 2 (https://510kreport.com/company/gemore-technology)
- Bio-Medical Research, Ltd.: 2 (https://510kreport.com/company/bio-medical-research)
- Kingfisher Healthcare NV: 1 (https://510kreport.com/company/kingfisher-healthcare)
- The Dezac Group: 1 (https://510kreport.com/company/dezac-group)
- Emsi: 1 (https://510kreport.com/company/emsi)
- Theratech, Inc.: 1 (https://510kreport.com/company/theratech)
- Pain Management Technologies: 1 (https://510kreport.com/company/pain-management-technologies)
- Skylark Device & Systems Co., Ltd.: 1 (https://510kreport.com/company/skylark-device-systems)

## Its most-cited devices
- K946299: PGS123 and HVS-123 (1995), cited by 3
- K912178: Bio Tens 601, 606 and 608 (3000) (1991), cited by 2
- K930535: IF400 (1994), cited by 2
- K983964: Batch #6060 Conductive Gel (1998), cited by 1
- K912642: EMS300, EMS400, EMS8000 (1991), cited by 1
- K923298: Micro 100,200,300, & 400 Tens (1992), cited by 1

## Recent decisions
- K990233: ST-302 Infrarex (Oct 27, 1999)
- K984506: SD-100 Skyear Thermometer (Jul 29, 1999)
- K981449: SD-956 Ultrasound Therapy (Dec 11, 1998)
- K983964: Batch #6060 Conductive Gel (Dec 9, 1998)
- K964437: GB-1002 Tens with Massage (Aug 14, 1998)
- K974585: IF-727 Interferential Stimulator (Mar 6, 1998)
- K964434: SD-970EMS Electrical Muscular Stimulator (Oct 9, 1997)
- K963729: SD-610M (Also Known as Standard Tens, SD-609M,SD-611M, GLC-I Standard) (Feb 13, 1997)

Source page: https://510kreport.com/company/skylark-device