FDA.reportPublic FDA data

Freestanding patient positioner, reusable

Definition
A preformed patient-contact device (e.g., cushion, pad, bolster, wedge, elevation pillow) designed to be placed freely on a flat surface (e.g., operating table, stretcher) to position and stabilize a patient or body part typically in preparation for and during various medical procedures [e.g., to align the head, neck and thorax to optimise laryngoscopy in anaesthesia]; it is not attached to a parent device. It is made of shock-absorbing materials (e.g., memory foam) to reduce pressure on the bony prominences of a body part (e.g., torso, arm, leg), and some types are inflatable to provide variable support (e.g., to level the spine in a lateral position). This is a reusable device.
GUDID devices
1,373
Last updated
2026-08-12 10:12:12

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00057475960018BIOS LivingThermor LtdSP0012024-08-19
00089904001634Action®ACTION PRODUCTS, INC.Positioner2021-01-14
00089904001641Action®ACTION PRODUCTS, INC.Positioner2021-01-14
00089904007766Action®ACTION PRODUCTS, INC.OR Table Replacement Pad2021-01-14
00089904010681Action®ACTION PRODUCTS, INC.Positioner2021-01-14
00749756401371DeRoyalDEROYAL INDUSTRIES, INC.M60-AP6002026-01-22
00810006680041Wipe Down Body Wedge w/Handle - Extra LongPRIMO INCBPW04XL2019-02-20
00810006680058Wipe Down Body Wedge Set - Standard PRIMO INCBPW102019-02-20
00810006680065Wipe Down Body Wedge Set - Standard PRIMO INCBPW112019-02-20
00810006680102Wipe Down Body Wedge Set - BariatricPRIMO INCBPW202019-02-20
00810006680232Wipe Down Body Wedge w/Handle - StandardPRIMO INCBPW042019-02-20
00810006680249Wipe Down Body Wedge w/Handle - LongPRIMO INCBPW04L2019-02-20
00810006681413Wipe Down Body Wedge w/Handle - Bariatric PRIMO INCBPW02C2019-02-20
00810006681420Wipe Down Body Wedge w/Handle - Bariatric PRIMO INCBPW02C-152019-02-20
00810006681437Wipe Down Body Wedge w/Handle - BariatricPRIMO INCBPW02C-192019-02-20
00810006681451Wipe Down Body Wedge w/Handle - BariatricPRIMO INCBPW02FC2019-02-20
00810006681468Wipe Down Body Wedge w/Handle - BariatricPRIMO INCBPW02FC-152019-02-20
00810006681475Wipe Down Body Wedge w/Handle - BariatricPRIMO INCBPW02FC-192019-02-20
00810006681529Wipe Down Body Wedge w/Handle - StandardPRIMO INCBPW04F2019-02-20
00810006681536Wipe Down Body Wedge w/Handle - LongPRIMO INCBPW04FL2019-02-20
00810006681543Wipe Down Body Wedge Set - Bariatric PRIMO INCBPW212019-02-20
00810006683745Wipe Down Body Wedge Set PRIMO INCBPW10F2021-07-26
00810006683752Wipe Down Body Wedge Set PRIMO INCBPW11F2021-07-26
00810006683769Wipe Down Body Wedge, RoundedPRIMO INCBPW04R2021-07-22
00810006683776Wipe Down Body Wedge, RoundedPRIMO INCBPW04LR2021-07-22
00810006683844Wipe Down Body Wedge Set, RoundedPRIMO INCBPW10R2021-07-26
00810006683851Wipe Down Body Wedge Set, RoundedPRIMO INCBPW11R2021-07-26
00810055880300Foam ProductsJOERNS HEALTHCARE, LLC8616EA2023-08-11
00810055880317Foam ProductsJOERNS HEALTHCARE, LLC8809EA2023-08-11
00810055880324Foam ProductsJOERNS HEALTHCARE, LLC8807EA2023-08-11
00810055880331Foam ProductsJOERNS HEALTHCARE, LLC2072EA2023-08-11
00810055880348Foam ProductsJOERNS HEALTHCARE, LLC8815EA2023-08-11
00810055880355Foam ProductsJOERNS HEALTHCARE, LLC4815EA2023-08-11
00810075280036BoneFoamBONE FOAM, INC.10-910-02-C2022-05-22
00810082220070Soule MedicalSOULE CO., THERG0100-245052022-09-15
00810082220094Soule MedicalSOULE CO., THERG21002022-09-15
00810082220100Soule MedicalSOULE CO., THERG21102022-09-16
00810082220117Soule MedicalSOULE CO., THERG2110-252022-09-16
00810082220124Soule MedicalSOULE CO., THERG21202022-09-16
00810082220131Soule MedicalSOULE CO., THERG21302022-09-16
00810082221022Soule MedicalSOULE CO., THESAC-CC2022-09-16
00810082221039Soule MedicalSOULE CO., THESAWL-CC2022-09-16
00810082221046Soule MedicalSOULE CO., THESAWM-CC2022-09-16
00810082221053Soule MedicalSOULE CO., THESAWS-CC2022-09-16
00810082221060Soule MedicalSOULE CO., THESCB5-CC2022-09-16
00810082221077Soule MedicalSOULE CO., THESCB7-CC2022-09-16
00810082221084Soule MedicalSOULE CO., THESCB9-CC2022-09-16
00810082221091Soule MedicalSOULE CO., THESEH-CC2022-09-16
00810082221107Soule MedicalSOULE CO., THESERLE-L-CC2022-09-16
00810082221114Soule MedicalSOULE CO., THESERLE-R-CC2022-09-16
00810082221121Soule MedicalSOULE CO., THESKB-CC2022-09-16
00810082221138Soule MedicalSOULE CO., THESLLT-CC2022-09-16
00810082221145Soule MedicalSOULE CO., THESLUEWL-CC2022-09-16
00810082221152Soule MedicalSOULE CO., THESLUEWS-CC2022-09-16
00810082221169Soule MedicalSOULE CO., THESLW-R-CC2022-09-16
00810082221176Soule MedicalSOULE CO., THESLW-S-CC2022-09-16
00810082221183Soule MedicalSOULE CO., THESOWL-CC2022-09-16
00810082221190Soule MedicalSOULE CO., THESOWS-CC2022-09-16
00810082221206Soule MedicalSOULE CO., THESRLE-CC2022-09-16
00810082221213Soule MedicalSOULE CO., THESRLE-CC2022-09-16
00810082221220Soule MedicalSOULE CO., THESRLE-PP-CC2022-09-16
00810082221237Soule MedicalSOULE CO., THESRLE-PP-CC-42022-09-16
00810082221244Soule MedicalSOULE CO., THESRLT-CC2022-09-16
00810082221251Soule MedicalSOULE CO., THESRPP-CC2022-09-16
00810082222920Soule MedicalSOULE CO., THEPU34772022-09-15
00810082223286Soule MedicalSOULE CO., THEWD18882022-09-08
00810082223293Soule MedicalSOULE CO., THEWD221292022-09-08
00810082223309Soule MedicalSOULE CO., THEWD2627122022-09-08
00810132044298HCS SourcingConcordance Healthcare Solutions LLC822002025-04-07
00810132044311HCS SourcingConcordance Healthcare Solutions LLC822022025-04-07
00810132044328HCS SourcingConcordance Healthcare Solutions LLC822032025-04-07
00817517026603Marketlab, IncMARKETLAB INC.1081922023-01-23
00817517026610Marketlab, IncMARKETLAB INC.1081932023-01-23
00817517026627Marketlab, IncMARKETLAB INC.1081942023-01-23
00817517026634Marketlab, IncMARKETLAB INC.1081962023-01-23
00817517026641Marketlab, IncMARKETLAB INC.1081972023-01-23
00817517026658Marketlab, IncMARKETLAB INC.1081982023-01-23
00840216120860PRIMO/ASP MEDICALAsp Global, LLCBPW04F-1-K2023-01-13
00840216120877PRIMO/ASP MEDICALAsp Global, LLCBPW04FL-1-K2023-01-13
00840216120884PRIMO/ASP MEDICALAsp Global, LLCBPW04R-1-K2023-01-13