Browse hierarchy: [Physical Medicine (PM)](/submissions/PM) → [Subpart D — Physical Medicine Prosthetic Devices](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices) → [21 CFR 890.3175](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/890.3175) → KIC — Cushion, Flotation # KIC · Cushion, Flotation _Physical Medicine · 21 CFR 890.3175 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KIC ## Overview - **Product Code:** KIC - **Device Name:** Cushion, Flotation - **Regulation:** [21 CFR 890.3175](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/890.3175) - **Device Class:** 1 - **Review Panel:** [Physical Medicine](/submissions/PM) ## Identification A flotation cushion is a device intended for medical purposes that is made of plastic, rubber, or other type of covering, that is filled with water, air, gel, mud, or any other substance allowing a flotation media, used on a seat to lessen the likelihood of skin ulcers. ## Classification Rationale Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. ## Recent Cleared Devices (20 of 29) Showing 20 most recent of 29 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K960189](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KIC/K960189.md) | GEL-T CUSHION | Span-America Medical Systems, Inc. | Feb 7, 1996 | SESE | | [K953352](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KIC/K953352.md) | PROTEAM CUSHION | Iskra.Med | Nov 29, 1995 | SESE | | [K954117](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KIC/K954117.md) | CUSTOMCARE SEATING SYSTEM | Span-America Medical Systems, Inc. | Oct 13, 1995 | SESE | | [K950085](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KIC/K950085.md) | MULTICURE(R) S GEL PAD | Multigestion (Deutschland) GmbH | Jul 13, 1995 | SESE | | [K945667](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KIC/K945667.md) | MICOS MICROPULSE(TM) ALTERNATING PRESSURE WHEELCHAIR CUSHION | Micos Medical Systems | Feb 21, 1995 | SESE | | [K941858](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KIC/K941858.md) | GEL CUSHION | Hollister, Inc. | May 5, 1994 | SESE | | [K911843](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KIC/K911843.md) | ZERO-G(TM) GEL/FOAM MATTRESS TOPPER | Steridyne Corp. | May 30, 1991 | SESE | | [K872739](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KIC/K872739.md) | SAFE-SEAT, LOW-PROFILE WHEELCHAIR CUSHION | D.A. Schulman, Inc. | Jul 30, 1987 | SESE | | [K864109](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KIC/K864109.md) | C' AIRECUSH SEAT CUSHION | Medical Industries America, Inc. | Nov 14, 1986 | SESE | | [K864108](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KIC/K864108.md) | PUSH CUSH | Medical Industries America, Inc. | Nov 14, 1986 | SESE | | [K861327](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KIC/K861327.md) | ROHO HEEL PAD | Roho, Inc. | Jun 2, 1986 | SESE | | [K855072](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KIC/K855072.md) | MAXIMUS CUSHION | Jay Medical, Ltd. | Mar 10, 1986 | SESE | | [K851814](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KIC/K851814.md) | WHEELCHAIR CUSHIONS | Dignicare | Jul 9, 1985 | SESE | | [K851027](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KIC/K851027.md) | SOF. CARE CUSHION & SOF-CARE CUSHION COVER | Gaymar Industries, Inc. | Jun 18, 1985 | SESE | | [K842380](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KIC/K842380.md) | PRESSURE RELIEF SEAT CUSHION | American Pharmaseal Div. Ahsc | Jun 28, 1984 | SESE | | [K842120](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KIC/K842120.md) | ZERO-G | Steridyne Corp. | Jun 8, 1984 | SESE | | [K834517](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KIC/K834517.md) | JAY CUSHION | Jay Medical, Ltd. | Jan 17, 1984 | SESE | | [K831247](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KIC/K831247.md) | SAFE-SEAT WHEELCHAIR CUSHION | D.A. Schulman, Inc. | May 16, 1983 | SESE | | [K830426](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KIC/K830426.md) | INFLATABLE INVALID RING | Maddak, Inc. | Apr 28, 1983 | SESE | | [K830427](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KIC/K830427.md) | ARM CUSHION | Maddak, Inc. | Mar 29, 1983 | SESE | ## Top Applicants - D.A. Schulman, Inc. — 2 clearances - Jay Medical, Ltd. — 2 clearances - Maddak, Inc. — 2 clearances - Medical Industries America, Inc. — 2 clearances - Span-America Medical Systems, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KIC](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KIC) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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