FDA.reportPublic FDA data

ANSiSTIM - PP

Primary DI
08908006064267
Brand
ANSiSTIM - PP
Company
NEUROSTIMULATION MEDTECH PRIVATE LIMITED
Model
ANSiSTIM - PP
Device description
ANSiSTIM - PP
Published
2026-03-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NHIStimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHIStimulator, Nerve, Electrical, Percutaneous (Pens), For Pain ReliefNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220397000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220397000ANSiStim-PPDyansys, Inc.2022-05-12NHI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08908006064267PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08908006064267089080060642678908006064267

GMDN Terms#

Term, Definition table
TermDefinition
Acupuncture electrical stimulation systemAn electrically-powered unit designed to be used specifically to apply electrical stimuli to acupuncture sites (electroacupuncture). It is an external low-intensity, low frequency pulse (usually 1 to 100 pulses per second), multimode generator intended to connect to acupuncture electrodes. The electrodes may be placed either on the skin, or through acupuncture needles that penetrate the skin at the acupuncture points. Some may use a probe to detect the acupuncture sites using visual or audio signals.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
916731981
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08908006064311Morph DeviceMorph Device2026-05-22
08908006064328POSP DevicePOSP Device2026-05-22
08908006064199Primary Relief Primary Relief 2026-03-16
08908006064205OpiEaseOpiEase2026-03-16
08908006064212NociRelief NociRelief 2026-03-16
08908006064229GiCalmGiCalm2026-03-16
08908006064236NS100NS1002026-03-16
08908006064243First Relief v1First Relief v12026-03-16
08908006064281ANSiSTIM-PP ANSiSTIM-PP 2026-03-16
08908006064250NEUMONANEUMONA2025-08-18
08908006064168POSP Device POSP Device 2025-05-19
08908006064090NeuroSolutions 100NeuroSolutions 1002024-07-19
08908006064106OpiReliefOpiRelief2024-07-19
08908006064113Morph DeviceMorph Device2024-07-20
08908006064120S.T. GenesisS.T. Genesis2024-07-20
08908006064083Drug Relief v1Drug Relief v12026-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08908006064328POSP DeviceNEUROSTIMULATION MEDTECH PRIVATE LIMITEDNHI2026-05-22
00850022775260SPRINTSPR THERAPEUTICS, INC.NHI2026-05-19
08908006064199Primary Relief NEUROSTIMULATION MEDTECH PRIVATE LIMITEDNHI2026-03-16
08908006064212NociRelief NEUROSTIMULATION MEDTECH PRIVATE LIMITEDNHI2026-03-16
08908006064236NS100NEUROSTIMULATION MEDTECH PRIVATE LIMITEDNHI2026-03-16
00850022775000SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775017SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775222SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775239SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775246SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775253SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775376SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775383SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775444SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775451SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775468SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775475SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775482SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775499SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775505SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775512SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775529SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775536SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775543SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775550SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775413SPRINTSPR THERAPEUTICS, INC.NHI2025-08-21
08908006064250NEUMONANEUROSTIMULATION MEDTECH PRIVATE LIMITEDNHI2025-08-18
08908006064168POSP Device NEUROSTIMULATION MEDTECH PRIVATE LIMITEDNHI2025-05-19
00850022775390SPRINTSPR THERAPEUTICS, INC.NHI2024-08-30
00850022775406SPRINTSPR THERAPEUTICS, INC.NHI2024-08-30