FDA.reportPublic FDA data

DONJOY PERFORMANCE

Primary DI
00190446241324
Brand
DONJOY PERFORMANCE
Company
DJO, LLC
Model
DP171SR01-BLK
Device description
WAIST TRIMMER, BLACK, ONE SIZE FITS MOST
Published
2022-05-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IQEORTHOSIS, LUMBAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQEOrthosis, LumbarPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190446241324PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190446241324001904462413241904462413240190446241324

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081840873
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190446780601CHATTANOOGA81-50102023-04-25
00190446780618CHATTANOOGA81-50112023-04-25
00190446750598CHATTANOOGA47382022-09-02
00190446750604CHATTANOOGA47822022-09-02
00190446757214CHATTANOOGA4782-12022-09-02
00190446757221CHATTANOOGA4738-12022-09-02
00888912036627PROCARE79-892002022-08-22
00888912292856CHATTANOOGA2761-102016-09-15
00888912292863CHATTANOOGA2761-22016-09-15
00888912294249CHATTANOOGA2789-102016-09-15
00888912294256CHATTANOOGA2789-22016-09-15
00888912296977CHATTANOOGA28742016-09-15
00888912297110CHATTANOOGA28762016-09-15
00888912297295CHATTANOOGA28782016-09-15
00888912335652CHATTANOOGA39-07012016-09-15
00888912335669CHATTANOOGA39-07022016-09-15
00888912267588CHATTANOOGA20252026-03-31
00888912267618CHATTANOOGA20272026-03-31
00888912267625CHATTANOOGA20282026-03-31
00888912267632CHATTANOOGA20292026-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810178882533CoreTechVIVE HEALTH LLCIQE2026-02-09
00810178884520CoreTechVIVE HEALTH LLCIQE2025-10-30
00810179882044CopperFitIdeavillage Products CorpIQE2025-10-10
00810179882099CopperFitIdeavillage Products CorpIQE2025-10-10
00810179882105CopperFitIdeavillage Products CorpIQE2025-10-10
00810113682686Tailback 27Manamed, Inc.IQE2025-09-19
00810113682693Tailback2-42Manamed, Inc.IQE2025-09-19
00810113682723Tailback2-64Manamed, Inc.IQE2025-09-19
00860014460807Boston Body Jacket, Single OpeningBoston Brace International, Inc.IQE2025-08-05
00860014460814Boston Body Jacket, Bivalve OpeningBoston Brace International, Inc.IQE2025-08-05
00860014460821Boston Overlap Brace (BOB)Boston Brace International, Inc.IQE2025-08-05
00636257203651MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257203668MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257203675MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257203682MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257203699MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257203705MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257203712MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257203729MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257203736MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257203743MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257203750MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257203767MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257204801MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257204818MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257204825MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257204832MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257204849MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257204856MEDIMEDI MANUFACTURING, INC.IQE2025-06-24
00636257204863MEDIMEDI MANUFACTURING, INC.IQE2025-06-24