Pressure Relief Seat Cushion
FDA 510(k) K842380 · American Pharmaseal Div. Ahsc
510(k) numberK842380
Submission
- Device name
- Pressure Relief Seat Cushion
- Applicant
- American Pharmaseal Div. Ahsc
Walker, MI, US - Received
- June 18, 1984
- Decision date
- June 28, 1984
- 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 |
|---|---|---|
| K874022 | Pharmaseal Wound Irrigation DeviceFQH · Traditional | 12/30/1987SE |
| K874517 | Pharmaseal Rubber Urethral CatheterKOD · Traditional | 12/03/1987SE |
| K874045 | Pharmaseal Endoscopy Prep Kit Upper and LowerNWU · Traditional | 12/03/1987SE |
| K873359 | Airlife Volume Venti. Circuit W/Clear Cap Ex ValveCAI · Traditional | 11/06/1987SE |
| K872228 | Pharmaseal Alternating Pressure Pad SystemFNM · Traditional | 09/04/1987SE |
| K872917 | Jinotti Suction/Oxygen Insufflation CatheterBSY · Traditional | 08/11/1987SE |
| K871429 | Antimicrobial Foley CatheterKOD · Traditional | 08/10/1987SE |
| K871770 | American Pharmaseal Wound DressingFRO · Traditional | 06/26/1987SN |
| K870387 | Euromedical, Endosoft Endotracheal TubeBTR · Traditional | 05/08/1987SE |
| K870977 | Pharmaseal T Type Thermocouple 100% Cath./ProbeKOD · Traditional | 04/01/1987SE |
Questions and answers
When was Pressure Relief Seat Cushion cleared by the FDA?
Pressure Relief Seat Cushion (K842380) received a 510(k) decision of Substantially Equivalent on June 28, 1984, 10 days after the submission was received.
What is the product code of K842380?
The FDA product code is KIC – Cushion, Flotation, a Class I (low risk) device regulated under 21 CFR 890.3175.