FDA.reportPublic FDA data

ExaStim

Primary DI
00850053287268
Brand
ExaStim
Company
Niche Biomedical, Inc.
Model
ExaStim Stimulation System - Professional US
Catalog number
EXA-001
Published
2026-07-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
SDOTranscutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SDOTranscutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And SensationPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252893000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252893000ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® Electrode Pad (PAD-013)Aneuvo2026-03-27SDO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850053287275Direct MarkingGS10
00850053287268PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850053287275008500532872758500532872750850053287275
00850053287268008500532872688500532872680850053287268

GMDN Terms#

Term, Definition table
TermDefinition
Spinal cord rehabilitation transcutaneous electrical stimulation systemAn electrically-powered device assembly intended to apply various modes of transcutaneous electrical stimulation to the spinal cord to improve or restore upper extremity sensory and motor function in adults with chronic neurological deficit resulting from incomplete spinal cord injury. It includes a portable electric current pulse generator and noninvasive electrodes. It is intended for use in the healthcare facility and in the home.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure00
Handling Environment Humidity00
Handling Environment Temperature00
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+1 (424) 256 2194contactus@aneuvo.com

Regulatory Flags#

DUNS number
080179632
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
00850053287404ExaStimPortable Stimulator Kit - Patient USEXA910012026-07-14
00850053287411ReCurePatient Electrode Kit - Professional USPEK900012026-07-14
00850053287428ReCurePatient Electrode Kit - Patient USPEK910012026-07-14
00850053287442ReCureElectrode Pad, 2 pack - Professional USPAD900012026-07-14
00850053287459ReCureElectrode Pad, 2 pack - Patient USPAD910012026-07-14
00850053287466ExaStimReturn Electrode Cable - Professional USCAB900012026-07-14
00850053287473ExaStimReturn Electrode Cable - Patient USCAB910012026-07-14
00850053287480ReCureStimulation Cable - Professional USCAB900032026-07-14
00850053287497ReCureStimulation Cable - Patient USCAB910032026-07-14
00850053287503ExaStimProgrammer - Professional USACC900012026-07-14
00850053287510ExaStimProgrammer - Patient USACC910012026-07-14
00850053287541ExaStimPortable Stimulator Kit - Professional USEXA900012026-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850053287404ExaStimNiche Biomedical, Inc.SDO2026-07-14
00850053287411ReCureNiche Biomedical, Inc.SDO2026-07-14
00850053287428ReCureNiche Biomedical, Inc.SDO2026-07-14
00850053287442ReCureNiche Biomedical, Inc.SDO2026-07-14
00850053287459ReCureNiche Biomedical, Inc.SDO2026-07-14
00850053287466ExaStimNiche Biomedical, Inc.SDO2026-07-14
00850053287473ExaStimNiche Biomedical, Inc.SDO2026-07-14
00850053287480ReCureNiche Biomedical, Inc.SDO2026-07-14
00850053287497ReCureNiche Biomedical, Inc.SDO2026-07-14
00850053287503ExaStimNiche Biomedical, Inc.SDO2026-07-14
00850053287510ExaStimNiche Biomedical, Inc.SDO2026-07-14
00850053287541ExaStimNiche Biomedical, Inc.SDO2026-07-14
08720908310033ARC-EX SystemONWARD Medical N.V.SDO2025-12-05
08720908310002ARC-EX SystemONWARD Medical N.V.SDO2024-12-27
08720908310040ARC-EX SystemONWARD Medical N.V.SDO2024-12-27