FDA.reportPublic FDA data

Neuspera SNM System

Primary DI
00850075633449
Brand
Neuspera SNM System
Company
NeuSpera Medical Inc.
Model
WBTS-XL
Device description
Wearable with Silicone - Extra Large
Published
2026-04-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
P240031003

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P240031003Neuspera Sacral Neuromodulation SystemNeuspera Medical, Inc.2025-06-17EZW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850075633449PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850075633449008500756334498500756334490850075633449

GMDN Terms#

Term, Definition table
TermDefinition
Personal device holder, reusableA portable device designed to be worn or carried by a patient/layperson to hold a portable medical device (e.g., long-term recorder, wireless antenna, portable oxygen equipment, urine collection bag, tracheostoma protector, infusion pump) during ambulation or sleep; it is neither designed to hold an invasive tube/catheter to the skin surface (i.e., not a catheter/tube holder), nor to house and protect a device from damage (i.e., not a rigid case/housing). It is typically designed as a wearable bag, pouch, belt or strap intended to pass through the bag’s slots, headband, clothing, or trolley with wheels. This is a reusable device.

Regulatory Flags#

DUNS number
033985298
Device count
1
Lot or batch
true
Manufacturing date on label
true
Contains natural rubber latex
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
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
00850075633258Neuspera SNM SystemWU-R-2XL2025-11-17

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
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
00850075633128Neuspera 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