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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
EP28-0305B-1 FDA UDI
Description
ELBOW SPLINT FDA UDI

Identifiers

Primary DI / UDI-DI
18100013408486 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
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

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

E.M Adams co, inc. by E.M. Adams — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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 ffe5a539-5220-4d43-be40-85031f4d5d43 37 fields · synced Jun 8, 2026