FDA.reportPublic FDA data

Flyte System

Primary DI
00860331002063
Brand
Flyte System
Company
PELVITAL USA, INC.
Model
MTI-1.5
Published
2026-07-06
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

Product Codes#

Code, Name table
CodeName
HIRPerineometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIRPerineometerObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240805000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240805000Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)Pelvital USA, Inc.2024-08-01HIR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860331002063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860331002063008603310020638603310020630860331002063

GMDN Terms#

Term, Definition table
TermDefinition
PerineometerA device consisting of a fluid-filled sack for intravaginal use that is attached to an external manometer. The device measures the strength of the perineal muscles by offering resistance to a patient's voluntary contractions of these muscles and is used to diagnose and to correct, through exercise, urinary incontinence or sexual dysfunction.

Regulatory Flags#

DUNS number
080346522
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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
00860331002032FlyteMTI-1 2023-06-30
00860331002001Flyte In-Home Pelvic Floor TreatmentMTI-12021-08-04
00860331002018Flyte In-Home Pelvic Floor TreatmentMTI-12021-08-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00864124000137Vaginal Tactile Ultrasound ImagerAdvanced Tactile Imaging, Inc.HIR2026-04-23
04719872333104LevinaZMI ELECTRONICS LTD.HIR2026-04-14
04719872333593LevinaZMI ELECTRONICS LTD.HIR2026-04-14
04719872333616LevinaZMI ELECTRONICS LTD.HIR2026-04-14
00810138370834DeliceBlush NoveltiesHIR2025-03-13
00819835024125WellnessBlush NoveltiesHIR2025-01-28
03770014642486Hinge Health Pelvic Trainer by PerifitX6 INNOVATIONSHIR2024-01-15
03770014642196Perifit Care+X6 INNOVATIONSHIR2024-01-04
04719871184769LifecareEVERYWAY MEDICAL INSTRUMENTS CO., LTD.HIR2023-08-25
04719871184776LifecareEVERYWAY MEDICAL INSTRUMENTS CO., LTD.HIR2023-08-25
04719871184783LifecareEVERYWAY MEDICAL INSTRUMENTS CO., LTD.HIR2023-08-25
04719871184790LifecareEVERYWAY MEDICAL INSTRUMENTS CO., LTD.HIR2023-08-25
04719871184806LifecareEVERYWAY MEDICAL INSTRUMENTS CO., LTD.HIR2023-08-25
04719871184813LifecareEVERYWAY MEDICAL INSTRUMENTS CO., LTD.HIR2023-08-25
04719871184820LifecareEVERYWAY MEDICAL INSTRUMENTS CO., LTD.HIR2023-08-25
04719871184837LifecareEVERYWAY MEDICAL INSTRUMENTS CO., LTD.HIR2023-08-25
00860331002032FlytePELVITAL USA, INC.HIR2023-06-30
07350075029219Intimina KegelSmart 2 RechargeableLeloi ABHIR2023-06-26
03770014642134Perifit CareX6 INNOVATIONSHIR2023-05-12
03770014642165Perifit CareX6 INNOVATIONSHIR2023-05-12
03770014642448PerifitX6 INNOVATIONSHIR2023-05-12
03770014642660PerifitX6 INNOVATIONSHIR2023-05-12
07350022278004Intimina KegelSmart Leloi ABHIR2022-05-26
04719871183960EverywayEVERYWAY MEDICAL INSTRUMENTS CO., LTD.HIR2022-03-17
04719871183977EverywayEVERYWAY MEDICAL INSTRUMENTS CO., LTD.HIR2022-03-17
04719871184844EverywayEVERYWAY MEDICAL INSTRUMENTS CO., LTD.HIR2022-03-17
00860331002001Flyte In-Home Pelvic Floor TreatmentPELVITAL USA, INC.HIR2021-08-04
00860331002018Flyte In-Home Pelvic Floor TreatmentPELVITAL USA, INC.HIR2021-08-04
00864124000106Vaginal Tactile ImagerAdvanced Tactile Imaging, Inc.HIR2020-11-10
00850005838135Intimate RosePLUS EV HOLDINGS INC.HIR2020-10-29