Identity
- Trade Name
- DARCO® Body Armor® Walker II FDA UDI
- Generic Name
- Lower-limb orthosis ankle/foot component, mechanical-resistance FDA UDI
- Device Name
- Medium Black low version FDA UDI
- Model / Reference
- BATS2 FDA UDI
- Description
- Medium Black low version FDA UDI
Identifiers
- Catalog Number
- BATS2 FDA UDI
- Primary DI / UDI-DI
- 00609271299252 FDA UDI
- FDA Product Code
- NOC FDA UDI
- GMDN Term
- Lower-limb orthosis ankle/foot component, mechanical-resistance FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.3910 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
No
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: Lower-limb orthosis ankle/foot component, mechanical-resistance
DARCO® Body Armor® Walker II by DARCO International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Lower-limb orthosis ankle/foot component, mechanical-resistance.
- DARCO® FXPro Walker Liner — DARCO International, Inc. · Class I
- DARCO® Body Armor® Walker II — DARCO International, Inc. · Class I
- DARCO® Body Armor® Walker II — DARCO International, Inc. · Class I
- Health Design Tall Leg Walker — DARCO International, Inc. · Class I
- Health Design Ankle Leg Walker — DARCO International, Inc. · Class I
- DARCO® Body Armor® Walker — DARCO International, Inc. · Class I
- DARCO® Body Armor® Walker II — DARCO International, Inc. · Class I
- DARCO® FX Pro™ Walker — DARCO International, 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 |
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Manufacturer
- Manufacturer
- DARCO International, Inc.
Sources (1)
- FDA UDI e9b7f4d2-a6e6-43e4-98a7-2829fe0006f5 34 fields · synced Jun 9, 2026