FDA.reportPublic FDA data

Comfytopia

Primary DI
00819567011646
Brand
Comfytopia
Company
Comfytopia, Inc.
Model
KP30
Device description
BRACOO KP30 Knee Fulcrum Wrap Ergonomic Stabilizer
Published
2025-07-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IQIOrthosis, Limb Brace

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQIOrthosis, Limb BracePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819567011646PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819567011646008195670116468195670116460819567011646

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-joint lower limb orthosisA prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of multiple joints of the lower body which will include the knee (e.g., hip and knee, knee and ankle). The device is typically adjustable and articulating. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
003944628
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00819567011233ComfytopiaSE222025-07-09
00819567011608ComfytopiaFP302025-07-09
00819567011615ComfytopiaFP30 2025-07-09
00819567011639ComfytopiaEP302025-07-09
00819567011660ComfytopiaFS102025-07-09
00819567012452ComfytopiaWS102025-07-09
00819567012469ComfytopiaWS102025-07-09
00819567016818ComfytopiaSE222025-07-09
00819567017839ComfytopiaES102025-07-09
00819567017846ComfytopiaES102025-07-09
00819567017853ComfytopiaFS102025-07-09
00819567017860ComfytopiaFS102025-07-09
00819567017877ComfytopiaFS102025-07-09
00819567017884ComfytopiaFS102025-07-09
00819567017891ComfytopiaKS102025-07-09
00819567017907ComfytopiaKS102025-07-09
00854194003107ComfytopiaWS102025-07-09
00854194003114ComfytopiaES102025-07-09
00854194003121ComfytopiaFS102025-07-09
00854194003138ComfytopiaKS102025-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190446660590PROCAREDJO, LLCIQI2026-07-31
00190446660606PROCAREDJO, LLCIQI2026-07-31
00190446660613PROCAREDJO, LLCIQI2026-07-31
00190446660620PROCAREDJO, LLCIQI2026-07-31
00190446660637PROCAREDJO, LLCIQI2026-07-31
00190446660644PROCAREDJO, LLCIQI2026-07-31
00810178883127ViveVIVE HEALTH LLCIQI2026-07-21
00810178883134ViveVIVE HEALTH LLCIQI2026-07-21
00810178883141ViveVIVE HEALTH LLCIQI2026-07-21
00810178883158ViveVIVE HEALTH LLCIQI2026-07-21
00400000326986MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000326993MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327006MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327013MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327020MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327037MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327044MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327051MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327068MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327075MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327082MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327099MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327105MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327112MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327129MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327136MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327143MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327150MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327167MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00400000327174MEDIMEDI MANUFACTURING, INC.IQI2026-07-20