FDA.reportPublic FDA data

Neuspera SNM System

Primary DI
00850075633128
Brand
Neuspera SNM System
Company
NeuSpera Medical Inc.
Model
ES-1
Device description
External Stimulator
Published
2025-11-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
EZWStimulator, Electrical, Implantable, For Incontinence

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZWStimulator, Electrical, Implantable, For IncontinenceGastroenterology, Urology3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P240031000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P240031000Neuspera Sacral Neuromodulation SystemNeuspera Medical, Inc.2025-06-17EZW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850075633128PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850075633128008500756331288500756331280850075633128

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous incontinence-control electrical stimulatorA device or device assembly available for use by a patient/layperson outside a clinical setting (e.g., in the home) designed to treat urinary and/or faecal incontinence through the transcutaneous (noninvasive) 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., wearable remote control) intended for wired or wireless connection to a skin gel pad with surface electrodes designed to be placed on the pubic area; the gel pad may be included in the device assembly. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
033985298
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850075633135Neuspera SNM SystemWBTS-S2026-04-29
00850075633425Neuspera SNM SystemWBTS-M2026-04-29
00850075633432Neuspera SNM SystemWBTS-L2026-04-29
00850075633449Neuspera SNM SystemWBTS-XL2026-04-29
00850075633456Neuspera SNM SystemWBT-S2026-04-29
00850075633463Neuspera SNM SystemWBT-M2026-04-29
00850075633470Neuspera SNM SystemWBT-L2026-04-29
00850075633487Neuspera SNM SystemWBT-XL2026-04-29
00850075633036Neuspera SNM SystemWU-L-XS2025-11-17
00850075633142Neuspera SNM SystemWU-L-S2025-11-17
00850075633159Neuspera SNM SystemWU-L-M2025-11-17
00850075633166Neuspera SNM SystemWU-L-L2025-11-17
00850075633173Neuspera SNM SystemWU-L-XL2025-11-17
00850075633180Neuspera SNM SystemWU-L-2XL2025-11-17
00850075633197Neuspera SNM SystemWU-L-3XL2025-11-17
00850075633203Neuspera SNM SystemWU-R-XS2025-11-17
00850075633210Neuspera SNM SystemWU-R-S2025-11-17
00850075633227Neuspera SNM SystemWU-R-M2025-11-17
00850075633234Neuspera SNM SystemWU-R-L2025-11-17
00850075633241Neuspera SNM SystemWU-R-XL2025-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850075633135Neuspera SNM SystemNeuSpera Medical Inc.EZW2026-04-29
00850075633425Neuspera SNM SystemNeuSpera Medical Inc.EZW2026-04-29
00850075633432Neuspera SNM SystemNeuSpera Medical Inc.EZW2026-04-29
00850075633449Neuspera SNM SystemNeuSpera Medical Inc.EZW2026-04-29
00850075633456Neuspera SNM SystemNeuSpera Medical Inc.EZW2026-04-29
00850075633463Neuspera SNM SystemNeuSpera Medical Inc.EZW2026-04-29
00850075633470Neuspera SNM SystemNeuSpera Medical Inc.EZW2026-04-29
00850075633487Neuspera SNM SystemNeuSpera Medical Inc.EZW2026-04-29
00199150005918NAMEDTRONIC, INC.EZW2026-03-27
00199150005925NAMEDTRONIC, INC.EZW2026-03-27
00850075633081Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-12-02
00850075633012Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633029Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633036Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633043Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633067Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633098Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633104Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633111Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633142Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633159Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633166Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633173Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633180Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633197Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633203Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633210Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633227Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633234Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633241Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17