FDA.reportPublic FDA data

Therafit Belts

Primary DI
00840252901904
Brand
Therafit Belts
Company
Therafin Corporation
Model
61203
Catalog number
61203
Device description
W X 1.75H PADS W/ METAL CLIPS&CAMLOCKS
Published
2023-07-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
ISRBand Or Belt, Pelvic Support

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISRBand Or Belt, Pelvic SupportPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840252901904PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840252901904008402529019048402529019040840252901904

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair/chair occupant restraint/supportA rigid or non-rigid device, typically a strap, belt, bar, harness or vest designed to be attached to a wheelchair/chair and/or its occupant to stabilize the occupant’s position for prevention of slips and/or falls from the appliance and/or to provide postural support. Some types may also be used to secure a wheelchair occupant in a wheelchair while travelling in a motor vehicle.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-843-7234Info@therafin.com

Regulatory Flags#

DUNS number
056630924
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840252904004Sensory Vest30217302172023-07-06
00840252904011Sensory Vest30218302182023-07-06
00840252904028Sensory Vest30219302192023-07-06
00840252904035Sensory Vest30220302202023-07-06
00840252904042Sensory Cuff30221302212023-07-06
00840252904059Sensory Cuff30222302222023-07-06
00840252904066Sensory Cuff30223302232023-07-06
00840252925597Molded J&L50475504752023-07-06
00840252927423Molded J&L51096510962023-07-06
00840252927454Molded J&L51099510992023-07-06
00840252927461Molded J&L51100511002023-07-06
00840252927478Molded J&L51101511012023-07-06
00840252927485Molded J&L51102511022023-07-06
00840252927492Molded J&L51103511032023-07-06
00840252927508Molded J&L51104511042023-07-06
00840252901089Multi-Axis50215502152023-07-06
00840252901096Surelock50218502182023-07-06
00840252901232ProFit50365503652023-07-06
00840252901249ProFit50366503662023-07-06
00840252901256ProFit50367503672023-07-06

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Primary DI, Brand, Company table
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04719879641868ComfyHealthComfy Health Group Co., Ltd.ISR2025-07-10
04719879641875ComfyHealthComfy Health Group Co., Ltd.ISR2025-07-10
04719879644562ComfyHealthComfy Health Group Co., Ltd.ISR2025-07-10
00819567011233ComfytopiaComfytopia, Inc.ISR2025-07-09
00819567016818ComfytopiaComfytopia, Inc.ISR2025-07-09
00810113579122ViveVIVE HEALTH LLCISR2025-05-20
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10810113579129ViveVIVE HEALTH LLCISR2025-05-20
10810113579136ViveVIVE HEALTH LLCISR2025-05-20
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10810113579150ViveVIVE HEALTH LLCISR2025-05-20
05061035460530Love NoobsROBUST VENTURES LTDISR2025-02-21
00810041981158CoreTechVIVE HEALTH LLCISR2024-09-06
10810041981155CoreTechVIVE HEALTH LLCISR2024-09-06
06973712280043AZMEDHengshui Tianjian Medical Supplies CO.,LTDISR2024-03-27
06973712280050AZMEDHengshui Tianjian Medical Supplies CO.,LTDISR2024-03-27
10326053118514Regard™Resource Optimization & Innovation, L.L.C.ISR2023-08-10
20326053118511Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.ISR2023-08-10
00840252901881Therafit BeltsTherafin CorporationISR2023-07-06
00840252901898Therafit BeltsTherafin CorporationISR2023-07-06
00840252902062Therafit BeltsTherafin CorporationISR2023-07-06
00840252902079Therafit BeltsTherafin CorporationISR2023-07-06
00840252902086Therafit BeltsTherafin CorporationISR2023-07-06
00840252902093Therafit BeltsTherafin CorporationISR2023-07-06
00840252902116Therafit BeltsTherafin CorporationISR2023-07-06
10810041980295CoreTechVIVE HEALTH LLCISR2023-06-15