FDA.reportPublic FDA data

MIO

Primary DI
00850042929070
Brand
MIO
Company
Mio Labs Inc.
Model
GBS-2104-G
Published
2022-09-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FRIScale, Stand-On, Patient

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRIScale, Stand-On, PatientGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850042929070PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850042929070008500429290708500429290700850042929070

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

Regulatory Flags#

DUNS number
117119317
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850042929346Health Wealth SafeTCS012024-01-29
00850042929377Health Wealth SafeTMB-2282-GTMB-2282-G2024-01-29
00850042929407TeleMate Health &TeleRPMTCS012024-01-29
00850042929438TeleMate Health &TeleRPMTMB-2282-GTMB-2282-G2024-01-29
00850042929285Brilliant CareTCS012023-11-13
00850042929315Brilliant CareTMB-2282-GTMB-2282-G2023-11-13
00850042929186MIOTeleBGM 2282-GTMB-2282-G2023-09-06
00850042929247TeleRPM & ChronicaTMB-2282-GTMB-2282-G2023-09-06
00850042929155MIOMCS012023-09-01
00850042929216TeleRPM & ChronicaTCS012023-09-01
00850042929063TeleRPMTMB-2092-G2025-02-06
00850042929322Health Wealth SafeTMB-2282-G2024-01-29
00850042929339Health Wealth SafeTTS012024-01-29
00850042929384TeleMate Health &TeleRPMTMB-2282-G2024-01-29
00850042929391TeleMate Health &TeleRPMTTS012024-01-29
00850042929261Brilliant CareTMB-2282-G2023-11-13
00850042929278Brilliant CareTTS012023-11-13
00850042929193TeleRPM & ChronicaTMB-2282-GTeleBGM 2282-G2023-09-06
00850042929209TeleRPM & ChronicaTTS012023-09-06
00850042929131MIOTeleBGM 2282-GTMB-2282-G2023-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00849987003761SR ScalesS R INSTRUMENTS, INC.FRI2026-06-26
00849987003778SR ScalesS R INSTRUMENTS, INC.FRI2026-06-26
00849987003785SR ScalesS R INSTRUMENTS, INC.FRI2026-06-26
00849987003792SR ScalesS R INSTRUMENTS, INC.FRI2026-06-26
00849987003808SR ScalesS R INSTRUMENTS, INC.FRI2026-06-26
00849987003815SR ScalesS R INSTRUMENTS, INC.FRI2026-06-26
00849987003822SR ScalesS R INSTRUMENTS, INC.FRI2026-06-26
00849987003839SR ScalesS R INSTRUMENTS, INC.FRI2026-06-26
00849987000029SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000036SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000135SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000142SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000159SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000166SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000173SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000180SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000197SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000203SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000210SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000258SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000265SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000449SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000777SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000784SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000791SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000807SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987001033SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987001040SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987001057SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987001064SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23