PAINVISION

Primary DI
04573224000317
Brand
PAINVISION
Company
SANYO SEIKO CO.,LTD.
Model
PS-2100
Published
2026-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
LLNDevice, Vibration Threshold Measurement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLNDevice, Vibration Threshold MeasurementNeurology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072882000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072882000PAIN VISION, MODEL PS-2100Osachi Co., Ltd.2009-01-08LLN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04573224000317PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04573224000317045732240003174573224000317

GMDN Terms#

Term, Definition table
TermDefinition
Somatosensory electrical stimulation systemAn assembly of devices used to apply precisely timed and repeatable electrical stimuli to the peripheral nerves, typically for evoked potential and other research procedures (e.g., functional mapping in epilepsy). It is usually a multichannel external stimulation system, consisting of external surface electrodes or invasive (i.e., needle) electrodes, and a pulse generator. It may be used as a component of more complex devices such as somatosensory evoked-potential recording systems.

Regulatory Flags#

DUNS number
701679508
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 Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08908022363016NEURO TOUCHYOSTRA LABS PRIVATE LIMITEDLLN2024-01-10
00702173355696CASEWR MEDICAL ELECTRONICS CO INCLLN2016-08-29