Identity
- Trade Name
- Trulife FDA UDI
- Generic Name
- Mechanical-resistance external ankle-foot prosthesis FDA UDI
- Device Name
- K3 Foot with Pyramid EUDAMEDTRULIFE ENERGY FOOT SIZE 23 LEFT #3 FDA UDI
- Model / Reference
- SEF190-23-L-3S3 EUDAMEDFDA UDI
- Description
- TRULIFE ENERGY FOOT SIZE 23 LEFT #3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00645517818542 EUDAMEDFDA UDI
- Basic UDI-DI
- 00645517FootK3YT EUDAMED
- FDA Product Code
- ISH FDA UDI
- EMDN Code
- Y062409 TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE) EUDAMED
- GMDN Term
- Mechanical-resistance external ankle-foot prosthesis FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3420 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
Yes
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Mechanical-resistance external ankle-foot prosthesis
A comprehensive mechanical- resistance external ankle-foot prosthesis designed to provide functional support during various activities. The Trulife Energy device is a cutting-edge solution for individuals with missing or damaged feet.
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Trulife, Inc.
Sources (2)
- FDA UDI cbf48ecb-c9e2-4baa-bfb1-428159aaa5b6 33 fields · synced Jul 23, 2026
- EUDAMED b62fb50a-0fc1-4c63-95af-ac17d21676a0 61 fields · synced Jul 23, 2026