FDA.report

Trulife

Primary DI
00645517818757
Brand
Trulife
Company
TRULIFE LIMITED
Model
SEF190-26-L-4M6
Device description
TRULIFE ENERGY FOOT SIZE 26 LEFT #4
Published
2022-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
ISHCOMPONENT, EXTERNAL, LIMB, ANKLE/FOOT

Product Code Classifications

CodeDeviceSpecialtyClass
ISHComponent, External, Limb, Ankle/FootPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00645517818757PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00645517818757006455178187576455178187570645517818757

GMDN Terms

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

Regulatory Flags

DUNS number
289728891
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
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 From This Company

Primary DIBrandModelCatalogPublished
00645517899350TrulifeTN250-22026-02-17
00645517899367TrulifeTN250-32026-02-17
00645517899374TrulifeTN250-42026-02-17
00645517899381TrulifeTN250-52026-02-17
00645517872773TrulifeSSF400-27-L-2 2025-09-19
00645517872780TrulifeSSF400-27-L-3 2025-09-19
00645517872827TrulifeSSF400-28-L-1 2025-09-19
00645517872834TrulifeSSF400-28-L-2 2025-09-19
00645517872872TrulifeSSF400-28-R-3 2025-09-19
00645517872889TrulifeSSF400-29-L-2 2025-09-19
00645517872933TrulifeSSF400-30-R-3 2025-09-19
00645517872988TrulifeSSF403-23-R-1 2025-09-19
00645517873039TrulifeSSF403-24-R-1 2025-09-19
00645517873084TrulifeSSF403-25-L-3 2025-09-19
00645517873138TrulifeSSF403-26-L-2 2025-09-19
00645517873183TrulifeSSF403-27-L-1 2025-09-19
00645517873190TrulifeSSF403-27-L-2 2025-09-19
00645517873237TrulifeSSF403-27-R-3 2025-09-19
00645517873244TrulifeSSF403-28-L-1 2025-09-19
00645517873282TrulifeSSF403-28-R-2 2025-09-19

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00645517872773TrulifeTRULIFE LIMITEDISH2025-09-19
00645517872780TrulifeTRULIFE LIMITEDISH2025-09-19
00645517872827TrulifeTRULIFE LIMITEDISH2025-09-19
00645517872834TrulifeTRULIFE LIMITEDISH2025-09-19
00645517872872TrulifeTRULIFE LIMITEDISH2025-09-19
00645517872889TrulifeTRULIFE LIMITEDISH2025-09-19
00645517872933TrulifeTRULIFE LIMITEDISH2025-09-19
00645517872988TrulifeTRULIFE LIMITEDISH2025-09-19
00645517873039TrulifeTRULIFE LIMITEDISH2025-09-19
00645517873084TrulifeTRULIFE LIMITEDISH2025-09-19
00645517873138TrulifeTRULIFE LIMITEDISH2025-09-19
00645517873183TrulifeTRULIFE LIMITEDISH2025-09-19
00645517873190TrulifeTRULIFE LIMITEDISH2025-09-19
00645517873237TrulifeTRULIFE LIMITEDISH2025-09-19
00645517873244TrulifeTRULIFE LIMITEDISH2025-09-19
00645517873282TrulifeTRULIFE LIMITEDISH2025-09-19
00645517873299TrulifeTRULIFE LIMITEDISH2025-09-19
00645517873305TrulifeTRULIFE LIMITEDISH2025-09-19
00645517873336TrulifeTRULIFE LIMITEDISH2025-09-19
00645517873343TrulifeTRULIFE LIMITEDISH2025-09-19
00645517873350TrulifeTRULIFE LIMITEDISH2025-09-19
00645517896175TrulifeTRULIFE LIMITEDISH2025-09-19
00645517896182TrulifeTRULIFE LIMITEDISH2025-09-19
00645517896199TrulifeTRULIFE LIMITEDISH2025-09-19
00645517896205TrulifeTRULIFE LIMITEDISH2025-09-19
00645517896212TrulifeTRULIFE LIMITEDISH2025-09-19
00645517896229TrulifeTRULIFE LIMITEDISH2025-09-19
00645517896236TrulifeTRULIFE LIMITEDISH2025-09-19
00645517896243TrulifeTRULIFE LIMITEDISH2025-09-19
00645517896250TrulifeTRULIFE LIMITEDISH2025-09-19