Identity
- Trade Name
- Trulife FDA UDI
- Generic Name
- Mechanical-resistance external ankle-foot prosthesis FDA UDI
- Device Name
- FOOT SHELL SEF 22 LT K12 FDA UDI
- Model / Reference
- SFC190-22-L-K12 FDA UDI
- Description
- FOOT SHELL SEF 22 LT K12 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00645517820965 FDA UDI
- FDA Product Code
- ISH FDA UDI
- GMDN Term
- Mechanical-resistance external ankle-foot prosthesis FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3420 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Mechanical-resistance external ankle-foot prosthesis
Trulife by Trulife, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mechanical-resistance external ankle-foot prosthesis.
- TruStep — COLLEGE PARK INDUSTRIES, INC. · Class I
- Iceross Comfort® Locking — Össur Iceland ehf. · Class I
- Tribute — COLLEGE PARK INDUSTRIES, INC. · Class I
- Venture — COLLEGE PARK INDUSTRIES, INC. · Class I
- Aviator — COLLEGE PARK INDUSTRIES, INC. · Class I
- Soleus — COLLEGE PARK INDUSTRIES, INC. · Class I
- Proprio Foot® — Össur Iceland ehf. · Class I
- Onyx — COLLEGE PARK INDUSTRIES, INC. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Trulife, Inc.
Sources (1)
- FDA UDI 9c6e3ee5-9dc6-4e10-8b17-fb4c87dd6e53 33 fields · synced Jun 4, 2026