FDA.reportPublic FDA data

Comfytopia

Primary DI
00819567011233
Brand
Comfytopia
Company
Comfytopia, Inc.
Model
SE22
Device description
BRACOO SE22 Waist trimmer Wrap Comfort Fit Trimmer Black L/XL-size
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
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
00819567011233PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819567011233008195670112338195670112330819567011233

GMDN Terms#

Term, Definition table
TermDefinition
Static magnetic orthopaedic orthosisA body-support orthopaedic device containing or impregnated with magnetized metals or metallic compounds, designed to be worn around a body area (e.g., shoulder, elbow, thoracic or lumbar spine region, knee, foot arch) and produce a weak magnetic flux field to assist the whole body’s innate healing capability to alleviate body aches and pains (e.g., from muscle soreness/stiffness, arthritis). 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
00819567011608ComfytopiaFP302025-07-09
00819567011615ComfytopiaFP30 2025-07-09
00819567011639ComfytopiaEP302025-07-09
00819567011646ComfytopiaKP302025-07-09
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
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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
00819567016818ComfytopiaComfytopia, Inc.ISR2025-07-09
00810113579122ViveVIVE HEALTH LLCISR2025-05-20
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10810041980295CoreTechVIVE HEALTH LLCISR2023-06-15