Gel Flotation Cushion
FDA 510(k) K813225 · Jefferson Industries, Inc.
510(k) numberK813225
Submission
- Device name
- Gel Flotation Cushion
- Applicant
- Jefferson Industries, Inc.
Mchenry, IL, US - Received
- November 10, 1981
- Decision date
- December 3, 1981
- 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.
Questions and answers
When was Gel Flotation Cushion cleared by the FDA?
Gel Flotation Cushion (K813225) received a 510(k) decision of Substantially Equivalent on December 3, 1981, 23 days after the submission was received.
What is the product code of K813225?
The FDA product code is KIC – Cushion, Flotation, a Class I (low risk) device regulated under 21 CFR 890.3175.