Soft-Cover
FDA 510(k) K921928 · Adroit Medical Systems, Inc.
510(k) numberK921928
Submission
- Device name
- Soft-Cover
- Applicant
- Adroit Medical Systems, Inc.
Morganton, NC, US - Received
- April 24, 1992
- Decision date
- November 6, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FMW – Cover, Mattress (Medical Purposes)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6190
- Specialty
- General Hospital
Other 510(k)s with product code FMW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K152884 | DermaTherapy Bed LinensFMW · Traditional | Precision Fabrics Group, Inc. | 06/20/2016SE |
| K061242 | Dermatherapy, Model 22216FMW · Traditional | Precision Fabrics Group, Inc. | 01/25/2007SE |
| K001003 | Z-NetFMW · Traditional | Demite Limited | 12/10/2001SE |
| K992702 | Event Allergen Barriers, Event Mattress Encasing, Event Duvet Encasing, Event Pillow…FMW · Traditional | Allergy Direct | 11/08/1999SE |
| K940327 | Intervent Allergen Exclusion Technology, Intervent Bedding System, Intervent Mattress…FMW · Traditional | W. L. Gore & Associates, Inc. | 02/25/1994SE |
| K935220 | Core Prevent Mattress ModificationFMW · Traditional | Paladin Medical, Inc. | 11/29/1993SE |
| K924807 | Reusable Incontient UnderpadFMW · Traditional | Perfect Fit Industries, Inc. | 02/10/1993SE |
| K924477 | Wipeable PillowFMW · Traditional | Perfect Fit Industries, Inc. | 01/29/1993SE |
| K923173 | Obalon CoverFMW · Traditional | Turnsoft, Inc. | 11/06/1992SE |
| K903382 | Allergy Control CoversFMW · Traditional | Allergy Control Products, Inc. | 11/02/1990SE |
More from Allergy Control Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K073712 | Soft Air, Model SA 4000 and Mistral Air, Model MA0100DWJ · Traditional | 06/06/2008SE |
| K973981 | Safepass Sterilization PouchKCT · Traditional | 01/29/1998SE |
| K970197 | HTP-1500 Localized Heat Therapy PumpILO · Traditional | 09/10/1997SE |
| K962983 | Sterile Soft-TempILO · Traditional | 01/10/1997SE |
| K921920 | Soft-TempDWJ · Traditional | 12/11/1992SE |
Questions and answers
When was Soft-Cover cleared by the FDA?
Soft-Cover (K921928) received a 510(k) decision of Substantially Equivalent on November 6, 1992, 196 days after the submission was received.
What is the product code of K921928?
The FDA product code is FMW – Cover, Mattress (Medical Purposes), a Class I (low risk) device regulated under 21 CFR 880.6190.