FDA.reportPublic FDA data

MyNotifi Fall Detection Device

Primary DI
00867239000269
Brand
MyNotifi Fall Detection Device
Company
MEDHAB, LLC
Model
Version 1
Device description
MyNotifi is an advanced emergency alert system that notifies family and friends automatically via an easy-to-use smartphone app should you fall. MyNotifi comes with the added flexibility and convenience of two devices for low prices. The fall detection device can be worn as a wrist band and/or can be worn on a belt clip. The device does not require monthly fees, does not require contract papers, does not require landline, and does not require the push of a button. The device is purchased with a one time fee.
Published
2018-06-28
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
true

Product Codes#

Code, Name table
CodeName
KQXGoniometer, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQXGoniometer, Ac-PoweredOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00867239000269PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00867239000269008672390002698672390002690867239000269

GMDN Terms#

Term, Definition table
TermDefinition
Bed/chair occupancy sensorA battery-powered electronic pressure pad designed to be placed under a bed and/or chair occupant (e.g., a geriatric patient, an Alzheimer's disease or dementia patient, a person with a disability, or a wheelchair user) who is at risk of vacating the bed/chair unattended and potentially falling. It is intended to detect diminished body-weight pressure should the user attempt to vacate the bed/chair, and functions in conjunction with an audible alarm or nurse call/home alert system which will provide an alert signal for assistance.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
107660874
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
00850023296009MyNotifi RxVersion 2MyNotifi RX - large2020-09-24
00850023296016MyNotifi RxVersion 2MyNotifi RX - medium2020-09-24
00850023296023MyNotifi RxVersion 2MyNotifi RX - small2020-09-24
00850023296276RPM2 Rx7 Size (0)Shoe insole size 0 (women 7.0 to 8.5) (men 5.0 to 2020-09-23
00850023296283RPM2 Rx7 Size (00)Shoe insole size 00 (women 3.0 to 6.5)2020-09-23
00850023296290RPM2 Rx7 Size (01)Shoe insole size 1 (women 9.0 to 10.5) (men 7.0 to2020-09-23
00850023296306RMP2 Rx7 Size (1)Shoe insole size 1 (women 9.0 to 10.5) (men 7.0 to2020-09-23
00850023296313RPM2 Rx7 Size (12)Shoe insole size (12) (women 9.0 to 10.5) (men 7.02020-09-23
00850023296320RPM2 Rx7 Size (2)Shoe insole size 2 (women 11.0 to 12.5) (men 9.0 t2020-09-23
00850023296337RPM2 Rx7 Size (2-3)Shoe insole size (2-3) (women 11.0 to 12.5) (men 92020-09-23
00850023296344RPM2 Rx7 Size (3)Shoe insole size 3 (women 13.0 to 15.0) (men 11.0 2020-09-23
00850023296351RPM2 Rx7 Size (4)Shoe insole size 4 (men 13.0 to 15.0)2020-09-23
00850023296085STEPRITE7 Size (4)Shoe insole size 4 (men 13.0 to 15.0)2020-09-24
00850023296030STEPRITE7 Size (00)Shoe insole size 00 (women 3.0 to 6.5)2020-09-23
00850023296047STEPRITE7 Size (0)Shoe insole size 0 (women 7.0 to 8.5) (men 5.0 to 2020-09-23
00850023296054STEPRITE7 Size (1)Shoe insole size 1 (women 9.0 to 10.5) (men 7.0 to2020-09-23
00850023296061STEPRITE7 Size (2)Shoe insole size 2 (women 11.0 to 12.5) (men 9.0 t2020-09-23
00850023296160STEPRITE7 Size (3)Shoe insole size 3 (women 13.0 to 15.0) (men 11.0 2020-09-23
00867239000207STEPRITE7STEPRITE 002019-09-23
00867239000214STEPRITE7STEPRITE SIZE 02019-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08600157703018TGCT & MeREMEPY HEALTH LTDKQX2026-05-24
00816271020698UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271020803myoRESEARCHNoraxon U.S.A., Inc.KQX2026-03-30
00816271020865UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271020872UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021039UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021046UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021053UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021060UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021077UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021084UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021091UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021107UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021114UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021121UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021138UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021145UltiumNoraxon U.S.A., Inc.KQX2026-03-30
04260242060316DIERS free²moveDIERS International GmbHKQX2026-03-09
00852184003670Motor Point Probe, Synchrony Synapse Biomedical, Inc.KQX2025-10-31
00852184003649Clinical Kit, SynchronySynapse Biomedical, Inc.KQX2025-10-23
00852184003779Kit, Wireless Charger USA 5WSynapse Biomedical, Inc.KQX2025-10-23
00850004866184ActivForce 2ActivBody, Inc.KQX2025-09-03
05694230564002NeckCare AssessmentsNeckCare Holding ehfKQX2025-05-30
05694230564033NeckCare DeviceNeckCare Holding ehfKQX2025-05-30
09413000126259myDigitalKnee®OPUM TECHNOLOGIES SERVICES LIMITEDKQX2025-03-25
09413000126273myDigitalKnee®OPUM TECHNOLOGIES SERVICES LIMITEDKQX2025-03-25
09413000123395Digital Knee®OPUM TECHNOLOGIES SERVICES LIMITEDKQX2025-01-15
09413000123418Digital Knee®OPUM TECHNOLOGIES SERVICES LIMITEDKQX2025-01-15
10853818007504USB C AdapterPRECISION BIOMETRICS INCKQX2024-09-03
00853818007491USB A to C CablePRECISION BIOMETRICS INCKQX2024-09-03