Comprinet, Comtesse and Bellavar Stockings
FDA 510(k) K905631 · Jobst Institute, Inc.
510(k) numberK905631
Submission
- Device name
- Comprinet, Comtesse and Bellavar Stockings
- Applicant
- Jobst Institute, Inc.
Toledo, OH, US - Received
- December 17, 1990
- Decision date
- March 7, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K122485 | Encircle Compression Therapy StockingDWL · Traditional | Encircle Medical Devices , Ltd. | 04/23/2013SE |
| 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 |
More from Bauerfeind AG
| 510(k) | Device | Decision |
|---|---|---|
| K955138 | Anti-Em/Gp StockingsDWL · Traditional | 12/13/1995SE |
| K953763 | Gladiator Antishock PantsLHX · Traditional | 11/28/1995SE |
| K925583 | Jobskin Continuing CareMDA · Traditional | 04/04/1994SE |
| K925154 | Jobst-CustomDWL · Traditional | 04/04/1994SE |
| K934639 | Jobst Athrombic Pump - System 2500JOW · Traditional | 02/09/1994SE |
| K922681 | Cutinova FoamKMF · Traditional | 08/31/1992SE |
| K921562 | Jobst Extremity Pump System 7500JOW · Traditional | 06/22/1992SE |
| K920444 | UltimateDWL · Traditional | 04/20/1992SE |
| K912232 | UlcercareMCY · Traditional | 08/14/1991SE |
| K911247 | Yours Truly Asymmetrical Breast FormKCZ · Traditional | 03/29/1991SE |
Questions and answers
When was Comprinet, Comtesse and Bellavar Stockings cleared by the FDA?
Comprinet, Comtesse and Bellavar Stockings (K905631) received a 510(k) decision of Substantially Equivalent on March 7, 1991, 80 days after the submission was received.
What is the product code of K905631?
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.