Device
Intrelief PFE is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stres...
Manufacturer
EasyMed Instruments Co., Ltd.
EasyMed Instruments Co., Ltd.
Model: Intrelief PFE
DI: 06942808259034
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-05-05
Current Version: 2026-05-13
Description
Intrelief PFE is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
bf545544-3364-450e-91e2-64beacebc3b0
Distribution Status:
In Commercial Distribution
DUNS Number:
526951168
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
06942808259034
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 65013
Name: Perineal orifice incontinence-control electrical stimulation system, home-use
Definition:
A device or device assembly available for use by a patient/layperson outside a clinical setting designed to treat urinary and/or faecal incontinence through the intravaginal/intra-anal application of electrical stimuli to the muscles of the pelvic floor to induce Kegel-like contractions. It consists of an electrically-powered external pulse generator/biofeedback unit with controls (e.g., hand-held remote control) intended for wired or wireless connection to a cylinder-like probe with surface electrodes designed to be inserted into the vagina and/or anus; the probe may be included in the device assembly. This is a reusable device.
FDA Product Codes
KPI
Stimulator, Electrical, Non-Implantable, For Incontinence