Skil-Care Gel Wedge, Flotation Pad
FDA 510(k) K801217 · Skil-Care Corp.
510(k) numberK801217
Submission
- Device name
- Skil-Care Gel Wedge, Flotation Pad
- Applicant
- Skil-Care Corp.
Mchenry, IL, US - Received
- May 21, 1980
- Decision date
- May 30, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KIC – Cushion, Flotation
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3175
- Specialty
- Physical Medicine
Other 510(k)s with product code KIC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K960189 | Gel-T CushionKIC · Traditional | Span-America Medical Systems, Inc. | 02/07/1996SE |
| K953352 | Proteam CushionKIC · Traditional | Iskra.Med | 11/29/1995SE |
| K954117 | Customcare Seating SystemKIC · Traditional | Span-America Medical Systems, Inc. | 10/13/1995SE |
| K950085 | Multicure(R) S Gel PadKIC · Traditional | Multigestion (Deutschland) GmbH | 07/13/1995SE |
| K945667 | Micos Micropulse(Tm) Alternating Pressure Wheelchair CushionKIC · Traditional | Micos Medical Systems | 02/21/1995SE |
| K941858 | Gel CushionKIC · Traditional | Hollister, Inc. | 05/05/1994SE |
| K911843 | Zero-G(Tm) Gel/Foam Mattress TopperKIC · Traditional | Steridyne Corp. | 05/30/1991SE |
| K872739 | Safe-Seat, Low-Profile Wheelchair CushionKIC · Traditional | D.A. Schulman, Inc. | 07/30/1987SE |
| K864109 | C' Airecush Seat CushionKIC · Traditional | Medical Industries America, Inc. | 11/14/1986SE |
| K864108 | Push CushKIC · Traditional | Medical Industries America, Inc. | 11/14/1986SE |
More from Medical Industries America, Inc.
| 510(k) | Device | Decision |
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| 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 Gel Wedge, Flotation Pad cleared by the FDA?
Skil-Care Gel Wedge, Flotation Pad (K801217) received a 510(k) decision of Substantially Equivalent on May 30, 1980, 9 days after the submission was received.
What is the product code of K801217?
The FDA product code is KIC – Cushion, Flotation, a Class I (low risk) device regulated under 21 CFR 890.3175.