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E.M. Adams Co, Inc.

FDA UDI

Class I (US FDA UDI)

by E.M. Adams

Identity

Trade Name
E.M. Adams Co, Inc. FDA UDI
Generic Name
Limb/torso/head restraint, reusable FDA UDI
Device Name
ELBOW SPLINT FDA UDI
Model / Reference
EP28-0305U-1 FDA UDI
Description
ELBOW SPLINT FDA UDI

Identifiers

Primary DI / UDI-DI
10840200314739 FDA UDI
510(k) Number
K971948 FDA UDI
FDA Product Code
FMQ FDA UDI
GMDN Term
Limb/torso/head restraint, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.6760 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Limb/torso/head restraint, reusable

E.M. Adams Co, Inc.'s ELBOW SPLINT is a non-rigid restraint device designed to temporarily restrict movement and facilitate patient positioning during medical procedures. This reusable device is made of various materials, such as fabric or nylon, and is anchored to a fixture for stability. It is intended for immobilization of the limbs, torso, or head, but not for specific joint immobilization.

Similar devices

Also classified as Limb/torso/head restraint, reusable.

Cleared under the same submission

K971948 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
E.M. Adams

Sources (1)

  • FDA UDI fb5ab6f2-35f1-4efd-a131-366460011ab9 36 fields · synced Jul 13, 2026