FDA.reportPublic FDA data

Neotech Care

Primary DI
00843776103014
Brand
Neotech Care
Company
NEOTECH CARE INC.
Model
NTCY001M_Grey_M
Published
2026-07-14
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
IQEOrthosis, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQEOrthosis, LumbarPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843776103014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843776103014008437761030148437761030140843776103014

GMDN Terms#

Term, Definition table
TermDefinition
Lumbar spine orthosisA prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to encompass the lumbar spine region of the trunk to support or immobilize deformities, fractures, sprains, or strains of the spine. This is a reusable device.

Regulatory Flags#

DUNS number
119475285
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
00843776100013Neotech CareNTCY003F_S2026-07-14
00843776100020Neotech CareNTCY003F_M2026-07-14
00843776100037Neotech CareNTCY003F_L2026-07-14
00843776100044Neotech CareNTCY003F_XL2026-07-14
00843776100051Neotech CareNTCY003F_XXL2026-07-14
00843776100099Neotech CareNTCY001_S2026-07-14
00843776102499Neotech CareNTCY001M_Beige_S2026-07-14
00843776102505Neotech CareNTCY001M_Beige_M2026-07-14
00843776102512Neotech CareNTCY001M_Beige_L2026-07-14
00843776102529Neotech CareNTCY001M_Beige_XL2026-07-14
00843776102536Neotech CareNTCY001M_Beige_XXL2026-07-14
00843776103007Neotech CareNTCY001M_Grey_S2026-07-14
00843776103021Neotech CareNTCY001M_Grey_L2026-07-14
00843776103038Neotech CareNTCY001M_Grey_XL2026-07-14
00843776103045Neotech CareNTCY001M_Grey_XXL2026-07-14
00843776105957Neotech CareNTCY001_M2026-07-14
00843776105964Neotech CareNTCY001_L2026-07-14
00843776105971Neotech CareNTCY001_XL2026-07-14
00843776105988Neotech CareNTCY001_XXL2026-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00843776100013Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776100020Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776100037Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776100044Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776100051Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776100099Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776102499Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776102505Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776102512Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776102529Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776102536Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776103007Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776103021Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776103038Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776103045Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776105957Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776105964Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776105971Neotech CareNEOTECH CARE INC.IQE2026-07-14
00843776105988Neotech CareNEOTECH CARE INC.IQE2026-07-14
00810178882533CoreTechVIVE HEALTH LLCIQE2026-02-09
00810178884520CoreTechVIVE HEALTH LLCIQE2025-10-30
00810179882044CopperFitIdeavillage Products CorpIQE2025-10-10
00810179882099CopperFitIdeavillage Products CorpIQE2025-10-10
00810179882105CopperFitIdeavillage Products CorpIQE2025-10-10
00810113682686Tailback 27Manamed, Inc.IQE2025-09-19
00810113682693Tailback2-42Manamed, Inc.IQE2025-09-19
00810113682723Tailback2-64Manamed, Inc.IQE2025-09-19
00860014460807Boston Body Jacket, Single OpeningBoston Brace International, Inc.IQE2025-08-05
00860014460814Boston Body Jacket, Bivalve OpeningBoston Brace International, Inc.IQE2025-08-05
00860014460821Boston Overlap Brace (BOB)Boston Brace International, Inc.IQE2025-08-05