Atlas FDA

KIC

29 FDA 510(k) clearances · Product code

27 daysmedian time to decision
98 days90th percentile
29clearances measured

FDA profile

Official device name
Cushion, Flotation
Device class
Class I (low risk)
Regulation
21 CFR 890.3175
Medical specialty
Physical Medicine
Adverse events (MAUDE)
1996: 1 · 2011: 10 · 2012: 18 · 2013: 7 · 2014: 13 · 2015: 31
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
GEL-T CUSHION (K960189)Span-America Medical Systems, Inc.1996-02-07
PROTEAM CUSHION (K953352)Iskra.Med1995-11-29
CUSTOMCARE SEATING SYSTEM (K954117)Span-America Medical Systems, Inc.1995-10-13
MULTICURE(R) S GEL PAD (K950085)Multigestion (Deutschland) GmbH1995-07-13
MICOS MICROPULSE(TM) ALTERNATING PRESSURE WHEELCHAIR CUSHION (K945667)Micos Medical Systems1995-02-21
GEL CUSHION (K941858)Hollister, Inc.1994-05-05
ZERO-G(TM) GEL/FOAM MATTRESS TOPPER (K911843)Steridyne Corp.1991-05-30
SAFE-SEAT, LOW-PROFILE WHEELCHAIR CUSHION (K872739)D.A. Schulman, Inc.1987-07-30
C' AIRECUSH SEAT CUSHION (K864109)Medical Industries America, Inc.1986-11-14
PUSH CUSH (K864108)Medical Industries America, Inc.1986-11-14
ROHO HEEL PAD (K861327)Roho, Inc.1986-06-02
MAXIMUS CUSHION (K855072)Jay Medical, Ltd.1986-03-10
WHEELCHAIR CUSHIONS (K851814)Dignicare1985-07-09
SOF. CARE CUSHION & SOF-CARE CUSHION COVER (K851027)Gaymar Industries, Inc.1985-06-18
PRESSURE RELIEF SEAT CUSHION (K842380)American Pharmaseal Div. Ahsc1984-06-28
ZERO-G (K842120)Steridyne Corp.1984-06-08
JAY CUSHION (K834517)Jay Medical, Ltd.1984-01-17
SAFE-SEAT WHEELCHAIR CUSHION (K831247)D.A. Schulman, Inc.1983-05-16
INFLATABLE INVALID RING (K830426)Maddak, Inc.1983-04-28
ARM CUSHION (K830427)Maddak, Inc.1983-03-29
RUBBER INFLATABLE RING (K823903)Duro-Med Ind., Inc.1983-01-14
WATER FLOATATION PAD (K820236)Gottfried Medical, Inc.1982-02-04
GEL FLOTATION CUSHION (K813225)Jefferson Industries, Inc.1981-12-03
INVALID CUSHION (K810649)First Industries, Inc.1981-03-26
SILICONE ELBOW, BED AND CHAIR PADS (K810440)Fred Sammons, Inc.1981-03-12
CONPHAR INVALID RING (K803137)Conphar, Inc.1981-01-08
SKIL-CARE GEL WEDGE, FLOTATION PAD (K801217)Skil-Care Corp.1980-05-30
CONDUCTIVE CUSHION (K780941)Markham Service Co., Inc.1978-07-27
FLOTATION UNIT, CHAIR (K760613)Medpro, Inc.1976-10-14

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Every clearance here is in the API, with alerts when new ones post.