Skil-Care Bed Rail Pads
FDA 510(k) K791993 · Skil-Care Corp.
510(k) numberK791993
Submission
- Device name
- Skil-Care Bed Rail Pads
- Applicant
- Skil-Care Corp.
Mchenry, IL, US - Received
- October 3, 1979
- Decision date
- October 26, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FNJ – Bed, Manual
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5120
- Specialty
- General Hospital
Other 510(k)s with product code FNJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K934298 | King KribFNJ · Traditional | Noritage, Inc. | 01/26/1994SE |
| K892877 | Cradle, Hospital Bed ClothingFNJ · Traditional | Warsaw Orthopedic, Inc. | 06/15/1989SE |
| K885241 | Bed, Adjustable, Hospital, Folding, Field, W/O MatFNJ · Traditional | King Mfg. Co. | 02/24/1989SE |
| K884542 | Sic 3999 Folding Adjustable Hospital BedFNJ · Traditional | Commercial Products & Engineering Co. | 11/21/1988SE |
| K881725 | Envirotent (Bed)FNJ · Traditional | Envirotents, Inc. | 11/08/1988SE |
| K881961 | Msi Standard Bed Models: L1097-64 and L1085-64FNJ · Traditional | Med Service, Inc. | 11/01/1988SE |
| K881964 | Msi 3003 Series BedFNJ · Traditional | Med Service, Inc. | 06/28/1988SE |
| K881962 | Msi 2005 Series BedFNJ · Traditional | Med Service, Inc. | 06/03/1988SE |
| K881043 | Folding Hospital Cot NSN 6530-00-299-8517FNJ · Traditional | Junkin Safety Appliance Co., Inc. | 04/12/1988SE |
| K870166 | Platform Mattress W/Disposable Bedpan BagFNJ · Traditional | George C. Kuhn | 03/13/1987SE |
More from George C. Kuhn
| 510(k) | Device | Decision |
|---|---|---|
| K010818 | Infant Limb Holder, Models 306080 & 306081FMQ · Traditional | 05/24/2001SE |
| K010644 | Cinch-Type Disposable Limb Holders, Model 912025FMQ · Traditional | 05/18/2001SE |
| K963458 | Padded Mitts/Padded-Plus Mitts/Finger Separator Padded Mitts/Rigid Palm Padded MittsFMQ · Traditional | 10/18/1996SE |
| K963459 | Support VestKID · Traditional | 10/15/1996SE |
| K963461 | Safety Poncho/Shoulder Strap PonchoKID · Traditional | 10/11/1996SE |
| K963460 | Roll BeltFMQ · Traditional | 10/09/1996SE |
| K963457 | Sleeper Jacket/Houdini Safety SleeperFMQ · Traditional | 10/09/1996SE |
| K963456 | Limb Holders-Reusable/Limb Holders-Disposable/Quick-Cuff Limb HolderFMQ · Traditional | 10/08/1996SE |
| K963455 | Sleeved Jacket/Sleeved Jacket with Slider ControlKID · Traditional | 10/08/1996SE |
| K963454 | Cushion Belt/Cushion Slider Belt/Adjusta-Loop Cushion Belt/Quick Release Cushion BeltFMQ · Traditional | 10/07/1996SE |
Questions and answers
When was Skil-Care Bed Rail Pads cleared by the FDA?
Skil-Care Bed Rail Pads (K791993) received a 510(k) decision of Substantially Equivalent on October 26, 1979, 23 days after the submission was received.
What is the product code of K791993?
The FDA product code is FNJ – Bed, Manual, a Class I (low risk) device regulated under 21 CFR 880.5120.