The following data is part of a premarket notification filed by Skylark Device & Systems Co., Ltd with the FDA for Sd-730 If-sds, Perfect Pulse If-sds.
| Device ID | K992652 |
| 510k Number | K992652 |
| Device Name: | SD-730 IF-SDS, PERFECT PULSE IF-SDS |
| Classification | Interferential Current Therapy |
| Applicant | SKYLARK DEVICE & SYSTEMS CO., LTD 34 CHUNG SHAN NORTH RD., 12TH FL., SEC. 3 Taipei, TW |
| Contact | George K.c. Chen |
| Correspondent | George K.c. Chen SKYLARK DEVICE & SYSTEMS CO., LTD 34 CHUNG SHAN NORTH RD., 12TH FL., SEC. 3 Taipei, TW |
| Product Code | LIH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-06 |
| Decision Date | 2000-02-03 |