Trexo Robotics
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Trexo Robotics FDA UDI
- Generic Name
- Programmable ambulation exoskeleton, home-use FDA UDI
- Device Name
- Trexo EUDAMEDTrexo Robotics Small Trexo Home 1 Shipment FDA UDI
- Model / Reference
- T0010 EUDAMEDT0010MP EUDAMEDT0010LP EUDAMEDT0010SH EUDAMEDT0010LH EUDAMEDT0010SP EUDAMEDA0001 FDA UDI
- Description
- Trexo Robotics Small Trexo Home 1 Shipment FDA UDI
Identifiers
- Catalog Number
- A001BHR FDA UDI
- Primary DI / UDI-DI
- 06287193215396 EUDAMED06287193215464 EUDAMED06287193211404 EUDAMED06287193215082 EUDAMED06287193215228 EUDAMED00628719321003 FDA UDI
- Basic UDI-DI
- 00628719T00104X EUDAMED
- FDA Product Code
- IKK FDA UDI
- EMDN Code
- Y061216 HIP-KNEE ORTHOSES EUDAMED
- GMDN Term
- Programmable ambulation exoskeleton, home-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 890.1925 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
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
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Programmable ambulation exoskeleton, home-use
Trexo Robotics by Trexo Robotics Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Programmable ambulation exoskeleton, home-use.
- ReWalk(TM) Personal — LIFEWARD, INC. · Class II
- ReWalk 7 Personal Exoskeleton Therapist Handheld Device — LIFEWARD, INC. · Class II
- Trexo Robotics — Trexo Robotics Inc. · Class II
- Trexo Robotics — Trexo Robotics Inc. · Class II
- Trexo Robotics — Trexo Robotics Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Trexo Robotics Inc.
Sources (6)
- FDA UDI 3364307e-a3c0-4646-8fe3-faf9e782c233 35 fields · synced Jul 30, 2026
- EUDAMED 9e3c379f-3730-4dda-b9e4-23477deefca2 61 fields · synced Jul 8, 2026
- EUDAMED 67f86708-b210-41f2-8f74-f693669f1dd9 61 fields · synced Jul 10, 2026
- EUDAMED e030b05b-ebea-463c-80d4-37ec7ad450dd 61 fields · synced Jul 15, 2026
- EUDAMED a1049542-9c52-4bdb-82cc-3f575f851223 61 fields · synced Jul 23, 2026
- EUDAMED 8bc2a3ef-0257-40ed-bd6d-34a1ab1da846 61 fields · synced Jul 30, 2026