The following data is part of a premarket notification filed by Tsung Hau Technology Co., Ltd. with the FDA for Shape To Fit Compression Wear.
| Device ID | K101906 |
| 510k Number | K101906 |
| Device Name: | SHAPE TO FIT COMPRESSION WEAR |
| Classification | Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) |
| Applicant | TSUNG HAU TECHNOLOGY CO., LTD. 3F, BUILDING A, NO.248-21, SINSHENG RD., Taiwan, R.o.c., TW 806 Kh |
| Contact | Peggy Kuo |
| Correspondent | Peggy Kuo TSUNG HAU TECHNOLOGY CO., LTD. 3F, BUILDING A, NO.248-21, SINSHENG RD., Taiwan, R.o.c., TW 806 Kh |
| Product Code | DWL |
| CFR Regulation Number | 880.5780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-08 |
| Decision Date | 2010-09-17 |
| Summary: | summary |