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Lower Limb Orthotics

FDA UDI

Class I (US FDA UDI)

by Boston Brace International, Inc.

Identity

Trade Name
Lower Limb Orthotics FDA UDI
Generic Name
Multiple-joint lower limb orthosis FDA UDI
Model / Reference
Reciprocating Gait Orthosis (RGO) FDA UDI

Identifiers

Catalog Number
Reciprocating Gait Orthosis (RGO) FDA UDI
Primary DI / UDI-DI
00860013109899 FDA UDI
FDA Product Code
MRI FDA UDI
GMDN Term
Multiple-joint lower limb orthosis FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3490 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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
MRI Safety
MR Unsafe FDA UDI

Category: Multiple-joint lower limb orthosis

Lower Limb Orthotics by Boston Brace International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple-joint lower limb orthosis.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Boston Brace International, Inc.

Sources (1)

  • FDA UDI b2a6546b-23cb-4b1d-9452-ece706abcd15 33 fields · synced May 30, 2026