FDA.report

Ames Walker

Primary DI
00840390707673
Brand
Ames Walker
Company
Legs 4 Life, LLC
Model
1
Catalog number
15-XL-BEIGE
Device description
AW Style 15 Sheer Support Closed Toe Pantyhose - 15-20 mmHg X-Large Beige
Published
2023-11-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FQLStocking, Medical Support (For General Medical Purposes)

Product Code Classifications

CodeDeviceSpecialtyClass
FQLStocking, Medical Support (For General Medical Purposes)General Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840390707673PrimaryGS10

GMDN Terms

TermDefinition
Compression/pressure sock/stocking, single-useA garment in the form of a sock or stocking intended to fit tightly over the leg and foot to apply compression/pressure (i.e., graduated or even-force), typically for the treatment/prevention of a disorder(s) of circulation [e.g., venous insufficiency, deep vein thrombosis (DVT)]. It is not a strip/roll binder or tubular support bandage, and is not designed to cover the pelvis. It is typically made of elastic material (e.g., circular knit nylon/Spandex yarns) and may be referred to as a flight sock; it does not include antimicrobial features. It is intended for use in the home or a clinical setting. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
(804) 640-7716rzell@ameswalker.com

Regulatory Flags

DUNS number
011882358
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00840390718525Ames Walker1707-S-BEIGE2026-02-17
00840390718532Ames Walker1707-M-BEIGE2026-02-17
00840390718549Ames Walker1707-L-BEIGE2026-02-17
00840390718556Ames Walker1707-XL-BEIGE2026-02-17
00840390718563Ames Walker1705-S-BEIGE2026-02-17
00840390718570Ames Walker1705-M-BEIGE2026-02-17
00840390718587Ames Walker1705-L-BEIGE2026-02-17
00840390718594Ames Walker1705-XL-BEIGE2026-02-17
00840390718600Ames Walker1100-XXL-BLACK2026-02-17
00840390718617Ames Walker141-S-BEIGE2026-02-17
00840390718624Ames Walker141-XXL-BEIGE2026-02-17
00840390718631Ames Walker118-XXL-BEIGE2026-02-17
00840390718648Ames Walker118 S LT.BEIGE2026-02-17
00840390718655Ames Walker118 M LT.BEIGE2026-02-17
00840390718662Ames Walker118 L LT.BEIGE2026-02-17
00840390718679Ames Walker118 XL LT.BEIGE2026-02-17
00840390718686Ames Walker1720-S-BLACK2026-02-17
00840390718693Ames Walker1720-M-BLACK2026-02-17
00840390718709Ames Walker1720-L-BLACK2026-02-17
00840390718716Ames Walker1720-XL-BLACK2026-02-17

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Primary DIBrandCompanyProduct codePublished
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08300496072515SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072522SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20
08300496072539SOLIDEACALZIFICIO PINELLI SRLFQL2026-03-20