FDA.reportPublic FDA data

New Balance

Primary DI
00888625011393
Brand
New Balance
Company
RENFRO CORPORATION
Model
N915 Black X-Large
Device description
Graduated Compression Support Sock Firm Support (20-30 mmHg) Over the Calf, Closed Toe
Published
2016-09-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)General Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123398000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123398000DR. SCHOLL'S COMPRESSION SOCKSRenfro Corporation2012-12-18DWL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888625011397PackageGS16In Commercial Distribution
00888625011393PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088862501139720888625011397
00888625011393008886250113938886250113930888625011393

GMDN Terms#

Term, Definition table
TermDefinition
Compression/pressure sock/stocking, reusableA 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 reusable device.

Contacts#

Phone, Email table
PhoneEmail
865-655-8134callcenter@renfro.com

Regulatory Flags#

DUNS number
003219318
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00042825634022Dr. Scholl'sDSL-7120-BL1-SK2017-08-08
00042825634039Dr. Scholl'sDSM-7000-BXL1-SK2017-08-08
00042825634046Dr Scholl'sDSM-7000-BL1-SK2017-08-08
00042825634053Dr. Scholl'sDSL-7110-BGL1-SK Beige Large2016-09-30
00888625001608New BalanceN915 Black Medium2016-11-08
00888625001615New BalanceN915 Black Large 2016-11-08
00888625001622New BalanceN915 White Medium2016-11-08
00888625001639New BalanceN915 White Large2016-09-30
00888625011409New BalanceN915 White X-Large2016-11-08
00042825534841Dr Scholl'sDSL-7110-BGL1 Beige Large2016-09-30
20042825634057Dr. Scholl'sDSL-7110-BGL1-SK Beige Large2016-09-30
20888625001602New BalanceN915 Black Medium2016-11-08
20888625001619New BalanceN915 Black Large 2016-11-08
20888625001626New BalanceN915 White Medium2016-11-08
20888625001633New BalanceN915 White Large2016-09-30
20888625011397New BalanceN915 Black X-Large 2016-09-30
20888625011403New BalanceN915 White X-Large2016-11-08
20042825634026Dr. Scholl'sDSL-7120-BL1-SK2017-08-08
20042825634033Dr. Scholl'sDSM-7000-BXL1-SK2017-08-08
20042825634040Dr Scholl'sDSM-7000-BL1-SK2017-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G4200211Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4200221Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4201011Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4201021Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4201031Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4201041Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4201061Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4202011Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4202021Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203001Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203011Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203021Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203031Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203041Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203051Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203061Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203071Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203081Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203091Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203311Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203321Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203331Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203341Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203351Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203361Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203371Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203381Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203391Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203411Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203421Compression StockingGottfried Medical, Inc.DWL2026-06-04