FDA.reportPublic FDA data

BlackBox

Primary DI
BB4B963WS501C1
Brand
BlackBox
Company
Blackbox Remote Patient Monitoring LLC
Model
WS-501C
Device description
Cellular weight scale with a large platform and high weight capacity
Published
2022-07-27
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRWScale, Patient

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRWScale, PatientGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
BB4B963WS501C1PackageHIBCC4In Commercial Distribution
B963WS501C0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Stand-on floor scale, electronicAn electrically-powered device designed to be placed on/integrated into the floor and upon which a patient is intended to stand to measure and display total body weight. It is not designed to weigh a wheelchair-bound patient or bed/stretcher.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4355129587Jared@BlackBoxRPM.com

Regulatory Flags#

DUNS number
117652799
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
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
B963103C0BlackBox RPMBPM-103C2025-01-01
B963WS501C0BlackBoxWS-501C2022-07-27
B963PO401W1BlackBox RPMPO-401W2020-10-20
B963102C1BlackBox RPMBPM-102C2021-08-01
B963BPM201W1BlackBox RPMBPM-201W2020-10-12
BB4B963PO401W1BlackBox RPMPO-401W2020-10-20
B963101C1BlackBoxBPM-101C2020-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00849987000005SR ScalesS R INSTRUMENTS, INC.FRW2026-06-23
00849987000012SR ScalesS R INSTRUMENTS, INC.FRW2026-06-23
00849987000272SR ScalesS R INSTRUMENTS, INC.FRW2026-06-23
00849987000289SR ScalesS R INSTRUMENTS, INC.FRW2026-06-23
00849987000333SR ScalesS R INSTRUMENTS, INC.FRW2026-06-23
00849987000883SR ScalesS R INSTRUMENTS, INC.FRW2026-06-23
00849987000890SR ScalesS R INSTRUMENTS, INC.FRW2026-06-23
00849987001767SR ScalesS R INSTRUMENTS, INC.FRW2026-06-23
00849987001774SR ScalesS R INSTRUMENTS, INC.FRW2026-06-23
00849987001781SR ScalesS R INSTRUMENTS, INC.FRW2026-06-23
00849987001798SR ScalesS R INSTRUMENTS, INC.FRW2026-06-23
00849987002320SR ScalesS R INSTRUMENTS, INC.FRW2026-06-23
00849987002344SR ScalesS R INSTRUMENTS, INC.FRW2026-06-23
00849987002771SR ScalesS R INSTRUMENTS, INC.FRW2026-06-23
00849987002788SR ScalesS R INSTRUMENTS, INC.FRW2026-06-23
00849987002818SR ScalesS R INSTRUMENTS, INC.FRW2026-06-23
00849987002825SR ScalesS R INSTRUMENTS, INC.FRW2026-06-23
00849987002832SR ScalesS R INSTRUMENTS, INC.FRW2026-06-23
00849987003020SR ScalesS R INSTRUMENTS, INC.FRW2026-06-23
04012030022927seca 406seca GmbH & Co. KGFRW2026-04-22
H933P11634Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FRW2025-12-03
04719846015753CharderCHARDER ELECTRONIC CO., LTD.FRW2025-08-07
04719846016040CharderCHARDER ELECTRONIC CO., LTD.FRW2025-08-07
40080196291237MEDLINEMEDLINE INDUSTRIES, INC.FRW2025-06-25
00860012873609WoddleWoddle Baby, Inc.FRW2025-06-02
10688503001051SavariaSavaria Concord LiftFRW2025-05-29
10688503001068SavariaSavaria Concord LiftFRW2025-05-29
00628725008264Smart ScaleCanadian Hospital Specialties LimitedFRW2025-02-28
00628725008271SMART SCALECanadian Hospital Specialties LimitedFRW2025-02-28
00093764604454A&D MedicalA&D COMPANY, LIMITEDFRW2024-10-16