Cushion, Flotation
Physical Medicine · 21 CFR 890.3175
Recent MDR events
172 adverse event reports on file
- ROHO QUADTRO SELECT HIGH PROFILE CUSHIONMay 28, 2026InjuryRoho, Inc.3008630266-2026-00005
- ROHO QUADTRO SELECT HIGH PROFILE CUSHIONMay 15, 2026InjuryRoho, Inc.3008630266-2026-00004
- SOFCARE CHAIR CUSHION BOX OF 6Apr 23, 2026MalfunctionStryker Medical-kalamazoo0001831750-2026-99228
- ROHO QUADTRO SELECT HIGH PROFILE CUSHIONFeb 20, 2026InjuryRoho, Inc.3008630266-2026-00003
- ROHO CONTOUR SELECT CUSHIONFeb 2, 2026MalfunctionRoho, Inc.3008630266-2026-00002
- ROHO QUADTRO SELECT HIGH PROFILE CUSHIONJan 8, 2026InjuryRoho, Inc.3008630266-2026-00001
- ROHO QUADTRO SELECT HIGH PROFILE CUSHIONDec 11, 2025InjuryRoho, Inc.3008630266-2025-00009
- ROHO LOW PROFILE SINGLE COMPARTMENT CUSHIONNov 26, 2025InjuryRoho, Inc.3008630266-2025-00008
- ROHO QUADTRO SELECT HIGH PROFILE CUSHIONNov 13, 2025InjuryRoho, Inc.3008630266-2025-00007
- ROHO HIGH PROFILE SINGLE COMPARTMENT CUSHIONSep 19, 2025InjuryRoho, Inc.,3008630266-2025-00006
Event type breakdown
Recalls
1 recall events for this product code
Registered firms
130 firms currently registered for this product code
Purple Innovation, Llc
Mc Donough, GA, US
E-life International Co., Ltd
Yonghe Dist., Taipei, TW
Dielectrics, Inc.
CHICOPEE, MA, US
Professional Specialties Co., Inc.
Memphis, TN, US
Picard Healthcare Technology (dongguan) Co. Ltd
Dongguan Guangdong, CN
Dongguan China Effort Healthcare Products Co., Ltd.
Dongguan City Guangdong, CN
Young Won Medical Co., Ltd.
Ansan-si Gyeonggi, KR
Agiliti Health - Corona
CORONA, CA, US
Accumed Corp.
Nigua San Cristobal, DO
Crest Medical Limited
Warrington Cheshire West and Chester, GB
Tynor Orthotics (p) Ltd.
Mohali Punjab, IN
Mass Corporation
Apia Tuamasaga, WS
Zhongshan First Medical Equipment Co., Ltd
Zhongshan Guangdong, CN
Ehob(jiaxing) Medical Product Co., Ltd.
Jiaxing Zhejiang, CN
Gf Health Products, Inc
Atlanta, GA, US
Bort Gmbh
WEINSTADT-BENZACH Baden-Wurttemberg, DE
Cascade Designs Nevada, Inc.
Reno, NV, US
Tops Medical Articles Industries Nantong Inc
Qidong City Jiangsu, CN
Tuper Medical Co., Ltd.
Dezhou City Shandong, CN
Drive Devilbiss Healthcare
Perris, CA, US
Gcmedica Enterprise Ltd.(wuxi)
WUXI Jiangsu, CN
Guangdong Yuehua Medical Instrument Factory Co., Ltd.
Shantou Guangdong, CN
Inmed (wuxi) Medical Device Co.,ltd
Wuxi Jiangsu, CN
Prime Med Shop Llc
Stafford, TX, US
Liven Sports Mfg. (xiamen) Co., Ltd.
XIAMEN Fujian, CN
510(k) clearances
29 clearances for this product code
- Span-America Medical Systems, Inc.Feb 7, 1996
K960189 · GEL-T CUSHION
- Iskra.MedNov 29, 1995
K953352 · PROTEAM CUSHION
- Span-America Medical Systems, Inc.Oct 13, 1995
K954117 · CUSTOMCARE SEATING SYSTEM
- Multigestion (Deutschland) GmbHJul 13, 1995
K950085 · MULTICURE(R) S GEL PAD
- Micos Medical SystemsFeb 21, 1995
K945667 · MICOS MICROPULSE(TM) ALTERNATING PRESSURE WHEELCHAIR CUSHION
- Hollister, Inc.May 5, 1994
K941858 · GEL CUSHION
- Steridyne Corp.May 30, 1991
K911843 · ZERO-G(TM) GEL/FOAM MATTRESS TOPPER
- D.A. Schulman, Inc.Jul 30, 1987
K872739 · SAFE-SEAT, LOW-PROFILE WHEELCHAIR CUSHION