FDA.reportPublic FDA data

Trulife

Primary DI
00645517852720
Brand
Trulife
Company
TRULIFE LIMITED
Model
T37T39PADKIT
Device description
PAD KIT SPINAL HYPERXTENSION T37/T39/T39S
Published
2022-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

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
00645517852720PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00645517852720006455178527206455178527200645517852720

GMDN Terms#

Term, Definition table
TermDefinition
Thoracic spine orthosisA prefabricated (non-customized) orthopaedic corset designed to encompasses the thoracic spine region of the trunk to support or immobilize deformities, fractures, sprains, or strains of the spine through compression of the abdomen. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
289728891
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
00645517899350TrulifeTN250-22026-02-17
00645517899367TrulifeTN250-32026-02-17
00645517899374TrulifeTN250-42026-02-17
00645517899381TrulifeTN250-52026-02-17
00645517872773TrulifeSSF400-27-L-2 2025-09-19
00645517872780TrulifeSSF400-27-L-3 2025-09-19
00645517872827TrulifeSSF400-28-L-1 2025-09-19
00645517872834TrulifeSSF400-28-L-2 2025-09-19
00645517872872TrulifeSSF400-28-R-3 2025-09-19
00645517872889TrulifeSSF400-29-L-2 2025-09-19
00645517872933TrulifeSSF400-30-R-3 2025-09-19
00645517872988TrulifeSSF403-23-R-1 2025-09-19
00645517873039TrulifeSSF403-24-R-1 2025-09-19
00645517873084TrulifeSSF403-25-L-3 2025-09-19
00645517873138TrulifeSSF403-26-L-2 2025-09-19
00645517873183TrulifeSSF403-27-L-1 2025-09-19
00645517873190TrulifeSSF403-27-L-2 2025-09-19
00645517873237TrulifeSSF403-27-R-3 2025-09-19
00645517873244TrulifeSSF403-28-L-1 2025-09-19
00645517873282TrulifeSSF403-28-R-2 2025-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10810178881564CoreTechVIVE HEALTH LLCMRI2025-05-19
04823097721872TM "Rehabilitimed" L-4M-3 S ComfortREABILITIMED TOVMRI2025-05-17
04823097721889TM "Rehabilitimed" L-4M-3 M ComfortREABILITIMED TOVMRI2025-05-17
04823097721896TM "Rehabilitimed" L-4M-3 L ComfortREABILITIMED TOVMRI2025-05-17
04823097721902TM "Rehabilitimed" L-4M-3 XL ComfortREABILITIMED TOVMRI2025-05-17