510(k) K101906
K101906 is an FDA 510(k) premarket notification submitted by Tsung Hau Technology Co., Ltd. for the device "SHAPE TO FIT COMPRESSION WEAR". The FDA issued a decision of Substantially Equivalent on September 17, 2010. The device falls under product code DWL (Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)), a Class II device regulated under 21 CFR 880.5780.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 17, 2010
- Date Received
- July 8, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
- Device Class
- Class II
- Regulation Number
- 880.5780
- Review Panel
- HO
- Submission Type