The following data is part of a premarket notification filed by Skylark Device & Systems Co., Ltd with the FDA for Bio-stim Kit.
| Device ID | K050174 |
| 510k Number | K050174 |
| Device Name: | BIO-STIM KIT |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | SKYLARK DEVICE & SYSTEMS CO., LTD 4F, 34, SEC. 3, CHUNG SHAN NORTH RD. Taipei, TW 104 |
| Contact | Betty Chien |
| Correspondent | Betty Chien SKYLARK DEVICE & SYSTEMS CO., LTD 4F, 34, SEC. 3, CHUNG SHAN NORTH RD. Taipei, TW 104 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-25 |
| Decision Date | 2005-09-07 |