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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
LIMB HOLDER FDA UDI
Model / Reference
70209-1 FDA UDI
Description
LIMB HOLDER FDA UDI

Identifiers

Primary DI / UDI-DI
10840200305218 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

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

Category: Limb/torso/head restraint, reusable

This non-rigid device, typically a strap or band or garment-like, is designed to restrict movement or facilitate patient positioning and stabilization during medical procedures while preventing injury/hazards. It's made of various materials and anchored to a fixture/furniture part, making it reusable. For patients with mobility issues or those undergoing specific procedures, this device can be an essential tool.

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 4b91f101-9419-4489-aa82-0d197bc521b6 36 fields · synced Jun 28, 2026