FDA.reportPublic FDA data

TEHLIN

Primary DI
04719883463470
Brand
TEHLIN
Company
TEH LIN PROSTHETIC & ORTHOPAEDIC INC.
Model
F-TGF-2RU26R
Device description
FEATHER CARBON FOOT W. ANKLE JOINT (26R)
Published
2025-01-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ISHComponent, External, Limb, Ankle/Foot

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISHComponent, External, Limb, Ankle/FootPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719883463470PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719883463470047198834634704719883463470

GMDN Terms#

Term, Definition table
TermDefinition
Mechanical-resistance external ankle-foot prosthesisA mechanical device which is a component of an external lower limb prosthesis designed to functionally replace, in part or total, an absent foot and/or ankle, wherein the principle of operation for dorsiflexion/plantar flexion control is based on media-free mechanical resistance (i.e., mechanical friction/elastic deflection with no fluid or gas operating media). The device may have various designs and functional features (e.g., SACH, SAFE, partial-foot, energy-storing carbon fibre spring blade type, adjustable heel height, split/sandal toe) for support during a variety of activities.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
657485074
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719883460356TEHLINC-TK-4P01P2025-01-10
04719883460370TEHLINC-TK-50SO2025-01-10
04719883461698TEHLINF-TSF-FFH0126L2025-01-10
04719883463432TEHLING-TCS-RA352025-01-10
04719883463449TEHLING-TCS-RA382025-01-10
04719883463456TEHLING-TCS-RA412025-01-10
04719883463463TEHLING-TCS-SA412025-01-10
04719883463494TEHLINJ-HT-12RTR2025-01-10
04719883463500TEHLINJ-HT-005R2025-01-10
04719883463517TEHLINJ-HT-004R2025-01-10
04719883463524TEHLINJ-HT-002L2025-01-10
04719883463531TEHLINJ-HT-010L2025-01-10
04719883464286TEHLING-TCS-SA352025-01-10
04719883464859TEHLING-TCS-SB242025-01-10
04719883464866TEHLING-TCS-RB182025-01-10
04719883464873TEHLING-TCS-RB212025-01-10
04719883464880TEHLING-TCS-RB242025-01-10
04719883460004TEHLINA-TGH-012023-10-31
04719883460028TEHLINA-TGK-40012023-10-31
04719883460035TEHLINA-TGK-40022023-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195411492992Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493005Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493012Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493029Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493036Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493043Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493050Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493067Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493074Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493081Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493098Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493104Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493111Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493128Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493135Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493142Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493159Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493166Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493173Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493180Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493197Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493203Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493210Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493227Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493234Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493241Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493258Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493265Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493272Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27
00195411493289Terrain VSCOLLEGE PARK INDUSTRIES, INC.ISH2026-08-27