FDA.reportPublic FDA data

NON FRANCHISE

Primary DI
00190446706977
Brand
NON FRANCHISE
Company
DJO, LLC
Model
88-578000994301
Device description
Soft Heel Cushions S
Published
2022-08-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
ITQJOINT, KNEE, EXTERNAL BRACE
ITWJOINT, ANKLE, EXTERNAL BRACE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITQJoint, Knee, External BracePhysical Medicine1
ITWJoint, Ankle, External BracePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190446706977PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190446706977001904467069771904467069770190446706977

GMDN Terms#

Term, Definition table
TermDefinition
Foot cushionA soft pillow or pad used to provide support and comfort to the user's feet, often during the treatment and/or prevention of musculoskeletal or circulatory disorders. The device may simply be used to alleviate pressure on the heels while the patient is sitting, or to slightly elevate the feet to reduce pressure and improve blood circulation in the lower extremity for the prevention of pressure sores and ulcers.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081840873
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190446968344DJO SURGICALS-2019632026-03-16
00190446953685DJO SURGICALS-2019592026-02-17
00190446953708DJO SURGICALS-2019582026-02-17
00888912408691DJO SURGICAL800-05-0242023-01-18
00190446940920DJO SURGICALS-2019462025-11-18
00190446660453PROCARE155-81-974272025-07-23
00190446660576PROCARE155-81-971502025-07-23
00190446662686PROCARE155-BH-1942025-07-23
00190446660354PROCARE155-79-843002025-07-14
00190446660583PROCARE155-79-84100C2025-07-14
00190446662785PROCARE155-BH827102025-07-14
00190446662891PROCARE155-81-874802025-07-14
00190446662907PROCARE155-81-874902025-07-14
00190446662914PROCARE155-81-874602025-07-14
00190446662921PROCARE155-81-874702025-07-14
00190446662792PROCARE155-81-873022025-07-11
00190446662808PROCARE155-81-873032025-07-11
00190446662815PROCARE155-81-873052025-07-11
00190446662822PROCARE155-81-873072025-07-11
00190446662839PROCARE155-81-873082025-07-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810113579665ViveVIVE HEALTH LLCITQ2026-02-09
00810113579672ViveVIVE HEALTH LLCITQ2026-02-09
00810113579689ViveVIVE HEALTH LLCITQ2026-02-09
00810113579696ViveVIVE HEALTH LLCITQ2026-02-09
00810179882440CopperFitIdeavillage Products CorpITQ2026-01-13
16974500613576Knee BraceGCMEDICA ENTERPRISE LTD.(WUXI)ITQ2025-12-12
16974500613583Knee braceGCMEDICA ENTERPRISE LTD.(WUXI)ITQ2025-12-12
16974500613446Ankle SupportGCMEDICA ENTERPRISE LTD.(WUXI)ITW2025-12-08
00810113683065ManaEZ ROM Ice ShortManamed, Inc.ITQ2025-10-17
00810113683522ManaEZ ROM Ice CureTechManamed, Inc.ITQ2025-10-03
00810113682891ManaEZ Ankle 06 Extra SmallManamed, Inc.ITW2025-09-26
00810113682907ManaEZ Ankle 06 SmallManamed, Inc.ITW2025-09-26
00810113682914ManaEZ Ankle 06 MediumManamed, Inc.ITW2025-09-26
00810113682921ManaEZ Ankle 06 LargeManamed, Inc.ITW2025-09-26
00810113682938ManaEZ Ankle 06 Extra LargeManamed, Inc.ITW2025-09-26
00810113682945ManaEZ Ankle 06 Extra Extra LargeManamed, Inc.ITW2025-09-26
00810113683126ManaEZ Night Splint, Plantar Fasciitis, SmallManamed, Inc.ITW2025-09-26
00810113683133ManaEZ Night Splint, Plantar Fasciitis, MediumManamed, Inc.ITW2025-09-26
00810113683140ManaEZ Night Splint, Plantar Fasciitis, LargeManamed, Inc.ITW2025-09-26
00810113683324ManaGO71 Ankle Brace Extra LargeManamed, Inc.ITW2025-09-26
00810113683331ManaGO71 Ankle Brace LargeManamed, Inc.ITW2025-09-26
00810113683348ManaGO71 Ankle Brace MediumManamed, Inc.ITW2025-09-26
00810113683355ManaGO71 Ankle Brace SmallManamed, Inc.ITW2025-09-26
00636257207727MEDIMEDI MANUFACTURING, INC.ITQ2025-09-11
00636257207734MEDIMEDI MANUFACTURING, INC.ITQ2025-09-11
00636257207741MEDIMEDI MANUFACTURING, INC.ITQ2025-09-11
00636257207758MEDIMEDI MANUFACTURING, INC.ITQ2025-09-11
00636257207765MEDIMEDI MANUFACTURING, INC.ITQ2025-09-11
00636257207772MEDIMEDI MANUFACTURING, INC.ITQ2025-09-11
00636257207789MEDIMEDI MANUFACTURING, INC.ITQ2025-09-11