FDA.reportPublic FDA data

NeuroSwitch

Primary DI
00864267000414
Brand
NeuroSwitch
Company
CONTROL BIONICS INCORPORATED
Model
PL-25-1000
Published
2018-03-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ILQSystem, Communication, Powered
IQASystem, Environmental Control, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILQSystem, Communication, PoweredPhysical Medicine2
IQASystem, Environmental Control, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00864267000414PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00864267000414008642670004148642670004140864267000414

GMDN Terms#

Term, Definition table
TermDefinition
Voice synthesizer/digitizerAn assistive device designed to deliver voice output based either in the reproduction of previously-recorded natural speech and/or on an electronic synthesized voice following a pre-established set of pronunciation rules. It typically consists of an electronic unit with a keyboard and screen; the keyboard may include letters, symbols, or both. The device is often customized to meet the user?s needs and is mostly used by patients with disabilities that partially or totally impair voice capabilities, including chronic progressive diseases.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
964598481
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00864267000421NeuroEDUCATORPL-21-10002018-03-06
00864267000407NeuroNodePL-27-10002018-03-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840828196864GEN4 DIRECT ACCESSCURBELL MEDICAL PRODUCTS, INC.IQA2026-07-23
00840828196871GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-07-23
00840828196895PAD-CORDED,UNDER SEAT,10"X15",92" CORDCURBELL MEDICAL PRODUCTS, INC.ILQ2026-07-23
00840828196901PAD WIRELESS, UNDER SEAT, 10"X15"CURBELL MEDICAL PRODUCTS, INC.ILQ2026-07-23
00840828196710P4600 90°,S4600,1 FT,R6,PS BREAKAWAYCURBELL MEDICAL PRODUCTS, INC.ILQ2026-07-08
008408281967274600,R6,BASIC,2 LT,DVCURBELL MEDICAL PRODUCTS, INC.ILQ2026-07-08
008408281967344600,R6,ENH,2 LT,DVCURBELL MEDICAL PRODUCTS, INC.ILQ2026-07-08
00840828196741RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-07-08
00840828196758GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-07-08
00840828196765RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-07-08
00840828196772RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-07-08
00840828196789GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-07-08
00840828196796GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-07-08
00840828196802GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-07-08
00840828196819GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-07-08
00840828196826GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-07-08
00840828196833GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-07-08
00840828196840GEN4 DIGITALCURBELL MEDICAL PRODUCTS, INC.IQA2026-07-08
00840828196666GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-06-09
00840828196673GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-06-09
00840828196680RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-06-09
00840828196468RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-05-27
00840828196475GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196482GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196499GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196505GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196512GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196529GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196536GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196543GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27