FDA.reportPublic FDA data

Keenhealth

Primary DI
08719699632677
Brand
Keenhealth
Company
Sevenground Trading B.V.
Model
K-PC-195-L
Device description
K-PC-195-L Posture corrector
Published
2019-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MRIOrthosis, Truncal/Orthosis, Limb

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRIOrthosis, Truncal/Orthosis, LimbPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08719699632677PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719699632677087196996326778719699632677

GMDN Terms#

Term, Definition table
TermDefinition
Cervicothoracic spine orthosisAn externally applied orthopaedic appliance or device, also known as a cervical-thoracic orthosis (CTO), designed to support or immobilize deformities, fractures, sprains, or strains of the cervicothoracic spine. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
492177197
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08719481723408iProvènOXI-27 black2026-03-09
08719699630161iProvènOXI-27 black 2019-04-05
08719699636910iProvènBBT-3742025-09-17
08719699636958iProvènBBT-2162025-09-12
08719699636828iProvènBPM-352024-08-09
08719699636729iProvènDMT-77B2023-09-15
08719699636644iProvènBBB-112 Grey2023-06-30
08719699636651iProvènBBB-112 Blue2023-06-30
08719699630901iProvenFMH-139-52021-03-01
08719699633230iProvenFMH-139-52019-06-04
08719699633254iProvenFMH-139-32019-06-04
08719699636552iProvènDMT-77BT2022-11-28
08719699636538iProvènBBT-1272022-11-09
08719699636507iProvènBPM-6172022-07-14
08719699636477iProvènDMT-772022-06-24
08719699636491iProvènBPM-4172022-06-24
08719699634633iProvenFK-127-CO2021-03-19
08719699636217iProvenDMT-489 WHITE2020-12-11
08719699636248iProvenDMT-489 BLACK2020-12-11
08719699633315iProvenDMT-316B2020-07-21

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00645517890821TrulifeTRULIFE LIMITEDMRI2025-09-11
00645517892757TrulifeTRULIFE LIMITEDMRI2025-09-11
00645517892764TrulifeTRULIFE LIMITEDMRI2025-09-11
00645517898766TrulifeTRULIFE LIMITEDMRI2025-09-11
00645517899077TrulifeTRULIFE LIMITEDMRI2025-09-11
00645517899121TrulifeTRULIFE LIMITEDMRI2025-09-11
00645517897776TrulifeTRULIFE LIMITEDMRI2025-08-25
04719879646108ComfyHealthComfy Health Group Co., Ltd.MRI2025-07-10
04719879646115ComfyHealthComfy Health Group Co., Ltd.MRI2025-07-10
04719879646122ComfyHealthComfy Health Group Co., Ltd.MRI2025-07-10
04719879646139ComfyHealthComfy Health Group Co., Ltd.MRI2025-07-10
04719879646146ComfyHealth Comfy Health Group Co., Ltd.MRI2025-07-10
04719879646153ComfyHealthComfy Health Group Co., Ltd.MRI2025-07-10
04719879646160ComfyHealthComfy Health Group Co., Ltd.MRI2025-07-10
04719879646177ComfyHealthComfy Health Group Co., Ltd.MRI2025-07-10
04719879646566ComfyHealthComfy Health Group Co., Ltd.MRI2025-07-10
04719879646580ComfyHealthComfy Health Group Co., Ltd.MRI2025-07-10
00819567011639ComfytopiaComfytopia, Inc.MRI2025-07-09
00819567012452ComfytopiaComfytopia, Inc.MRI2025-07-09
00819567012469ComfytopiaComfytopia, Inc.MRI2025-07-09
00819567017839ComfytopiaComfytopia, Inc.MRI2025-07-09
00819567017846ComfytopiaComfytopia, Inc.MRI2025-07-09
00854194003107ComfytopiaComfytopia, Inc.MRI2025-07-09
00854194003114ComfytopiaComfytopia, Inc.MRI2025-07-09
00854194003480ComfytopiaComfytopia, Inc.MRI2025-07-09
00810178881567CoreTechVIVE HEALTH LLCMRI2025-05-19
10810178881564CoreTechVIVE HEALTH LLCMRI2025-05-19