Zero-G(Tm) Gel/Foam Mattress Topper
FDA 510(k) K911843 · Steridyne Corp.
510(k) numberK911843
Submission
- Device name
- Zero-G(Tm) Gel/Foam Mattress Topper
- Applicant
- Steridyne Corp.
Riviera Beach, FL, US - Received
- April 25, 1991
- Decision date
- May 30, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| K861327 | Roho Heel PadKIC · Traditional | Roho, Inc. | 06/02/1986SE |
More from Roho, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K925352 | Clean Cuff Blood Pressure Cuff LinerDXQ · Traditional | 01/12/1993SE |
| K911269 | Mercury and Glass Fever ThermometerFLK · Traditional | 05/15/1991SE |
| K842120 | Zero-GKIC · Traditional | 06/08/1984SE |
| K821314 | Fever MeterKDP · Traditional | 05/28/1982SE |
| K801458 | Winter Head DressingFQM · Traditional | 07/28/1980SE |
Questions and answers
When was Zero-G(Tm) Gel/Foam Mattress Topper cleared by the FDA?
Zero-G(Tm) Gel/Foam Mattress Topper (K911843) received a 510(k) decision of Substantially Equivalent on May 30, 1991, 35 days after the submission was received.
What is the product code of K911843?
The FDA product code is KIC – Cushion, Flotation, a Class I (low risk) device regulated under 21 CFR 890.3175.