FDA.reportPublic FDA data

EMSRUN

Primary DI
06974567742809
Brand
EMSRUN
Company
Wuxi Emsrun Technology Co., Ltd.
Model
PZGD0003
Published
2022-12-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
06974567742809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974567742809069745677428096974567742809

GMDN Terms#

Term, Definition table
TermDefinition
Pelvic binder, reusableA belt-like support designed to be wrapped tightly around the pelvis (around the greater trochanters) of a patient suspected of a pelvic fracture to support the pelvis during transportation. It is typically intended to be used in an emergency setting to stabilize pelvic fractures. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
542972552
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974567745800EMSRUNPZQJ00022023-05-29
06974567741116EMSRUNPZJE00022022-12-02
06974567741147EMSRUNPZSI00082022-12-02
06974567742632EMSRUNPZSI00062022-12-02
06974567742649EMSRUNPZQJ00012022-12-02
06974567740515EMSRUNWSX-H2022-12-06
06974567742267EMSRUNCR-032022-12-06
06974567745411Lightning X Products,IncLXCP1002022-12-07
06974567742717EMSRUNPZBA00012022-12-02
06974567742724EMSRUNPZBA00122022-12-02
86974567746698RHINO RESCUEPZJJ00072023-10-10
86974567746926RHINO RESCUEPZJJ00072023-06-12
9697456774669566974567746694PZJJ00072023-10-10
96974567746923RHINO RESCUEPZJJ00072023-06-12
06974567749631Rhino RescuePZJJ00012022-12-08
06974567746692RHINO RESCUEPZJJ00072024-08-08
06974567746920RHINO RESCUEPZJJ00072024-08-08
06974567747989RHINO RESCUEPZJJ00072023-03-14
16974567747986RHINO RESCUEPZJJ00072023-03-14
06974567745428Lightning X Products,IncLXEFB2022-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719879646603ComfyhealthComfy Health Group Co., Ltd.ISR2025-12-08
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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
00810113579139ViveVIVE HEALTH LLCISR2025-05-20
00810113579146ViveVIVE HEALTH LLCISR2025-05-20
00810113579153ViveVIVE HEALTH LLCISR2025-05-20
10810113579129ViveVIVE HEALTH LLCISR2025-05-20
10810113579136ViveVIVE HEALTH LLCISR2025-05-20
10810113579143ViveVIVE HEALTH LLCISR2025-05-20
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
00840252901904Therafit 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