CASE

Primary DI
00702173355696
Brand
CASE
Company
WR MEDICAL ELECTRONICS CO INC
Model
IV
Published
2016-08-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
K910624000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K910624000CASE IV COMPUTER AIDED SENSORY EVALUATOR VERSION 4Wr Medical Electronics Co.1992-01-17LLN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00702173355696PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00702173355696007021733556967021733556960702173355696

GMDN Terms#

Term, Definition table
TermDefinition
Vibratory biothesiometerAn electronic instrument intended to produce vibrations that are applied to a part of the body (often the great toe) in a range of intensities to noninvasively measure vibratory sensation threshold. Sometimes referred to as a vibrameter, It is typically used for neuropathological diagnoses and evaluation of the neurological health effects of diabetes mellitus, exposure to neurotoxic compounds (e.g., solvents or heavy metals), poor ergonomic working conditions, chemotherapy or trauma.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
651-604-8400info@wrmed.com

Regulatory Flags#

DUNS number
006196604
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00702173456508HRV Acquire56502016-07-25
00702173131870Surgical Probe Monopolar31872016-08-29
00702173131887Surgical Probe, Monopolar w/Protected Plug31882016-08-29
00702173132174Silverstein Facial Nerve Stimulator Remote Probe32172016-08-29
00702173139005Hilger Dual Stim39002016-08-29
00702173139050Hilger Dual-Stimulator Remote Probe39052016-08-29
00702173139104Silverstein Facial Nerve StimulatorS82016-08-29
00702173122755TherabathTB92020-03-11
00702173122809TherabathTB102019-11-06
00702173151885Q-Sweat51882016-09-12
00702173151915Meridian™ Iontophoretic Drug Delivery Electrode51912016-09-12
00702173152929Meridian™ Iontophoretic Drug Delivery Electrode52922017-06-06
00702173155920Iontophor®-II6111PM/DX2017-02-21
00702173123202TherabathTB62016-08-29
00702173123226TherabathTB72016-08-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04573224000317PAINVISIONSANYO SEIKO CO.,LTD.LLN2026-05-22
08908022363016NEURO TOUCHYOSTRA LABS PRIVATE LIMITEDLLN2024-01-10