Encircle Compression Therapy Stocking
FDA 510(k) K122485 · Encircle Medical Devices , Ltd.
510(k) numberK122485
Submission
- Device name
- Encircle Compression Therapy Stocking
- Applicant
- Encircle Medical Devices , Ltd.
Palos Verdes Estates, CA, US - Received
- August 14, 2012
- Decision date
- April 23, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DWL – Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5780
- Specialty
- General Hospital
Other 510(k)s with product code DWL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K141127 | Medline Anti-Embolism StockingDWL · Traditional | Medline Industries, Inc. | 08/21/2014SE |
| K131496 | Bellavar / Custom Seamless Soft (A.K.A. Comtesse)DWL · Special | Bsn Medical, Inc. | 07/10/2013SE |
| K123820 | Bossong Hosiery Medical Compression Stockings 8-15 MMHG, Bossong Hosiery Anti-Embolism…DWL · Traditional | Bossong Hosiery Mills, Inc. | 04/02/2013SE |
| K123085 | Futuro (TM) Travel Knee-Highs; Futuro (TM) Travel Socks; Futuro (TM) Travel Stockings…DWL · Traditional | 3M Company | 12/20/2012SE |
| K123561 | Elvarex/Elvarex Soft/Elvarex Soft SeamlessDWL · Special | Bsn Medical, Inc. | 12/18/2012SE |
| K123398 | Dr. Scholl's Compression SocksDWL · Traditional | Renfro Corporation | 12/18/2012SE |
| K121106 | Truform Ready-To-Wear Compression Arm Sleece Truform Ready-To-Wear Compression GauntletDWL · Traditional | Surgical Appliance Industries, Inc. | 04/27/2012SE |
| K112769 | Curad Compression HosieryDWL · Traditional | Medline Industries, Inc. | 03/01/2012SE |
| K111662 | Venotrain CuraflowDWL · Traditional | Bauerfeind AG | 10/04/2011SE |
| K101614 | Heelsafe DVT Hose, Models 00800-00804, 00805-00809DWL · Traditional | Dm Systems, Incorporated | 01/13/2011SE |
Questions and answers
When was Encircle Compression Therapy Stocking cleared by the FDA?
Encircle Compression Therapy Stocking (K122485) received a 510(k) decision of Substantially Equivalent on April 23, 2013, 252 days after the submission was received.
What is the product code of K122485?
The FDA product code is DWL – Stocking, Medical Support (To Prevent Pooling Of Blood In Legs), a Class II (moderate risk) device regulated under 21 CFR 880.5780.