FDA.reportPublic FDA data

Comfyhealth

Primary DI
04719879646658
Brand
Comfyhealth
Company
Comfy Health Group Co., Ltd.
Model
TP35
Device description
BRACOO TP35 Thumb Advanced Reinforced stabilization Black Free size
Published
2026-10-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
04719879646658PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719879646658047198796466584719879646658

GMDN Terms#

Term, Definition table
TermDefinition
Wrist/hand orthosisAn externally applied orthopaedic appliance or apparatus designed to support, correct, or improve function of the wrist and hand through actions such as alignment, hinge-support, or dorsiflexion assistance. This is a reusable device.

Regulatory Flags#

DUNS number
658202517
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719879646610ComfyhealthBP622026-10-28
04719879646627ComfyhealthBP622026-10-28
04719879646634ComfyhealthBP622026-10-28
04719879646672ComfyhealthWB322026-10-28
04719879646696ComfyhealthWS302026-10-28
04719879646603ComfyhealthTP342025-12-08
04719879641868ComfyHealthSE232025-07-10
04719879641875ComfyHealthSE232025-07-10
04719879642889ComfyHealthFP312025-07-10
04719879644562ComfyHealthBP612025-07-10
04719879646009ComfyHealthKP322025-07-10
04719879646108ComfyHealthEE922025-07-10
04719879646115ComfyHealthEE922025-07-10
04719879646122ComfyHealthEE922025-07-10
04719879646139ComfyHealthEE922025-07-10
04719879646146ComfyHealth EE922025-07-10
04719879646153ComfyHealthEE922025-07-10
04719879646160ComfyHealthEE922025-07-10
04719879646177ComfyHealthEE922025-07-10
04719879646566ComfyHealthTB502025-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719879646672ComfyhealthComfy Health Group Co., Ltd.MRI2026-10-28
04719879646696ComfyhealthComfy Health Group Co., Ltd.MRI2026-10-28
00650551006794ILSO™PMT CORPORATIONMRI2026-07-18
00650551006800ILSO™PMT CORPORATIONMRI2026-07-17
00650551006817ILSO™PMT CORPORATIONMRI2026-07-17
00650551006824ILSO™PMT CORPORATIONMRI2026-07-17
00650551006831ILSO™PMT CORPORATIONMRI2026-07-17
00650551006848ILSO™PMT CORPORATIONMRI2026-07-17
00650551006855ILSO™PMT CORPORATIONMRI2026-07-17
00650551006862ILSO™PMT CORPORATIONMRI2026-07-17
00650551006879ITLSO™PMT CORPORATIONMRI2026-07-17
00650551006886ITLSO™PMT CORPORATIONMRI2026-07-17
00650551006893ITLSO™PMT CORPORATIONMRI2026-07-17
00650551006909ITLSO™PMT CORPORATIONMRI2026-07-17
00650551006916ITLSO™PMT CORPORATIONMRI2026-07-17
00650551006923ITLSO™PMT CORPORATIONMRI2026-07-17
00650551006930ITLSO™PMT CORPORATIONMRI2026-07-17
00650551006947ITLSO™PMT CORPORATIONMRI2026-07-17
00650551006954ILSO™PMT CORPORATIONMRI2026-07-17
00650551006961ITLSO™PMT CORPORATIONMRI2026-07-17
00850040983005WoodyKnowsM&M Pure Air Systems LLCMRI2026-05-19
00850040983012WoodyKnowsM&M Pure Air Systems LLCMRI2026-05-19
00850040983029WoodyKnowsM&M Pure Air Systems LLCMRI2026-05-19
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