FDA.reportPublic FDA data

OvuSense

Primary DI
05060508530121
Brand
OvuSense
Company
VIO HEALTHTECH LIMITED
Model
M400
Device description
M400 OvuFirst Starter Pack - M426 OvuFirst Skin Worn Sensor and M032 OvuSense App
Published
2021-05-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LHDDevice, Fertility Diagnostic, Proceptive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHDDevice, Fertility Diagnostic, ProceptiveUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060508530121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060508530121050605085301215060508530121

GMDN Terms#

Term, Definition table
TermDefinition
Thermometric fertility analyserA hand-operated, battery-powered, electronic, instrument used for recording basal body temperature and cycle length to identify the fertile and infertile phases of the menstrual cycle. The device consists of a basal body temperature thermometer and a microprocessor programmed with a mathematical algorithm to calculate and identify temperature shifts. It is used to predict ovulation to optimize the chances for becoming pregnant or for determining safe periods where sexual intercourse may take place. It is typically a noninvasive, automatic device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+441926800502support@ovusense.com

Regulatory Flags#

DUNS number
347449352
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060508530107OvuSenseM032 iOS2021-07-23
05060508530114OvuSenseM032 Android2021-07-23
05060508530091OvuSenseM4262021-05-01
05060508530039OvuSenseM3002017-12-11
05060508530046FertiloScopeFTO 1.402018-10-17
05060508530053OvuSenseM0262017-12-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06430060159860Fertile WindowOuraring Inc.LHD2025-11-14
06430060159877Fertile WindowOuraring Inc.LHD2025-11-14
06430060159983Fertile WindowOuraring Inc.LHD2024-11-12
00194253312512Cycle Tracking 4.0APPLE INC.LHD2024-11-01
00194253312529Cycle Tracking 4.0APPLE INC.LHD2024-11-01
06430060159990Fertile WindowOuraring Inc.LHD2024-10-28
04260749840039Clue AppBioWink GmbHLHD2023-07-27
04260749840046Clue AppBioWink GmbHLHD2023-07-27
04260749840022Clue ConceiveBioWink GmbHLHD2023-05-14
04260749840015Clue ConceiveBioWink GmbHLHD2023-05-14
07350014630100Cycle TrackingNaturalcycles Nordic ABLHD2023-04-19
07629999054073DaysyValley Electronics AGLHD2022-12-07
07629999894334Lady-CompValley Electronics AGLHD2022-12-07
09120095900274femSense Ovulation TrackerSteadySense GmbHLHD2022-10-26
07640184680464Ava FertilityAVA Sciences-FMTC GmbHLHD2022-09-29
07640184680136Ava FertilityAVA Sciences-FMTC GmbHLHD2022-09-21
00194252845967Cycle Tracking 3.0APPLE INC.LHD2022-07-27
00194252845974Cycle Tracking 3.0APPLE INC.LHD2022-07-27
00850003500478BeurerBEURER NORTH AMERICA, L.P.LHD2021-10-01
05060508530107OvuSenseVIO HEALTHTECH LIMITEDLHD2021-07-23
05060508530114OvuSenseVIO HEALTHTECH LIMITEDLHD2021-07-23
09120095900021femSense FertilitySteadySense GmbHLHD2021-07-15
06938444982498OT80-Beurer Ovulation Predictor and Fertility Tracking KitEquinox Biotech Co., Ltd.LHD2021-06-30
09120095900014femSense KinderwunschSteadySense GmbHLHD2021-05-17
05060508530091OvuSenseVIO HEALTHTECH LIMITEDLHD2021-05-01
00850003500560OVY by BeurerBEURER NORTH AMERICA, L.P.LHD2020-06-01
00850003500430BeurerBEURER NORTH AMERICA, L.P.LHD2019-12-09
20850003500434BeurerBEURER NORTH AMERICA, L.P.LHD2019-12-09
07290016672183Tyto DeviceTYTO CARE LTDLHD2019-01-24
07290016672213TytoHomeTYTO CARE LTDLHD2019-01-24