FDA.reportPublic FDA data

KNEE SLEEVE NEOPRENE

Primary DI
00733657234206
Brand
KNEE SLEEVE NEOPRENE
Company
ALIMED, INC.
Model
66296/NA/NA/SM
Published
2022-12-01
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITQJOINT, KNEE, EXTERNAL BRACE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITQJoint, Knee, External BracePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00733657234206PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00733657234206007336572342067336572342060733657234206

GMDN Terms#

Term, Definition table
TermDefinition
Compression/pressure tubular garmentA device in the form of a tube intended to tightly fit over and apply compression/pressure (i.e., graduated or even-force) to a part of a limb, typically for the treatment/prevention of a disorder(s) of circulation [e.g., venous insufficiency, deep vein thrombosis (DVT)], to control scarring, and/or to manage lymphoedema; it is neither a strip/roll binder, glove, sock/stocking, nor tubular support bandage. It is typically made of cotton or synthetic elastic material (e.g., Lycra and Spandex); it does not include antimicrobial features. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(781)329-2900customerservice@alimed.com

Regulatory Flags#

DUNS number
056007248
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00733657301038ATEC KIT 4 STRAPS96114529700181532024-08-02
00733657288667ATEC STRAP 2 X 84IN 2 CLOSURE PELVIC LONG96119629700182042024-08-02
00733657288674ATEC STRAP 2 X 72IN 2 CLOSURE PELVIC SHORT96119729700182052024-08-02
00733657288681ATEC STRAP 2 X 42IN 2 CLOSURE THORACIC96119829700182062024-08-02
00733657230253CUSH DROP AWAY POMMEL 16X168892429700113712022-12-15
00733657230260DROP AWAY POMMEL CUSHION 18X168892529700113722022-12-15
00733657240054CATH LAB IMMOBILIZER93189829700134112022-12-15
00733657245035STRAP UNIVERSAL UNIBODY, 5WX65L9-93129700188652022-12-15
00733657283594STRAP UNIVERSAL 3IN X 72IN 10/PK75361029700099892022-12-15
00733657283600STRAP UNIVERSAL 3IN X 72IN 25/PK62575362529700099912022-12-15
00733657283624STRAP UNIVERSAL 4IN x 72IN 10/PK75391029700099962022-12-15
00733657283631STRAP UNIVERSAL 4IN x 72IN 25/PK75392529700099982022-12-15
00733657283648STRAP UNIVERSAL 4IN x 72IN 50/PK75395029700099992022-12-15
00733657283662STRAP UNIVERSAL 4IN x 72IN 100/PK753910029700099972022-12-15
00733657290684ROLLER FOAM FULL ROLL 36" LONG X 6" WIDE ALIMED 3/CS31716032022-12-01
00656204000201HARNESS PAVLIK TYPE51968/NA/LG2022-12-01
00656204000218HARNESS PAVLIK TYPE51968/NA/MD2022-12-01
00656204000225HARNESS PAVLIK TYPE51968/NA/SM2022-12-01
00656204000232HARNESS PAVLIK TYPE51968/NA/XL2022-12-01
00656204004940AFO CHILD LEFT66132/NA/LL2022-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810113579665ViveVIVE HEALTH LLCITQ2026-02-09
00810113579672ViveVIVE HEALTH LLCITQ2026-02-09
00810113579689ViveVIVE HEALTH LLCITQ2026-02-09
00810113579696ViveVIVE HEALTH LLCITQ2026-02-09
00810179882440CopperFitIdeavillage Products CorpITQ2026-01-13
16974500613576Knee BraceGCMEDICA ENTERPRISE LTD.(WUXI)ITQ2025-12-12
16974500613583Knee braceGCMEDICA ENTERPRISE LTD.(WUXI)ITQ2025-12-12
00810113683065ManaEZ ROM Ice ShortManamed, Inc.ITQ2025-10-17
00810113683522ManaEZ ROM Ice CureTechManamed, Inc.ITQ2025-10-03
00636257207727MEDIMEDI MANUFACTURING, INC.ITQ2025-09-11
00636257207734MEDIMEDI MANUFACTURING, INC.ITQ2025-09-11
00636257207741MEDIMEDI MANUFACTURING, INC.ITQ2025-09-11
00636257207758MEDIMEDI MANUFACTURING, INC.ITQ2025-09-11
00636257207765MEDIMEDI MANUFACTURING, INC.ITQ2025-09-11
00636257207772MEDIMEDI MANUFACTURING, INC.ITQ2025-09-11
00636257207789MEDIMEDI MANUFACTURING, INC.ITQ2025-09-11
06971503604528comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.ITQ2025-08-28
00190446660453PROCAREDJO, LLCITQ2025-07-23
00749756395489DeRoyalDEROYAL INDUSTRIES, INC.ITQ2025-07-23
00819567017891ComfytopiaComfytopia, Inc.ITQ2025-07-09
00819567017907ComfytopiaComfytopia, Inc.ITQ2025-07-09
00854194003138ComfytopiaComfytopia, Inc.ITQ2025-07-09
10810113579891ViveVIVE HEALTH LLCITQ2025-07-08
10810113579907ViveVIVE HEALTH LLCITQ2025-07-08
10810113579914ViveVIVE HEALTH LLCITQ2025-07-08
10810113579921ViveVIVE HEALTH LLCITQ2025-07-08
00810113579931ViveVIVE HEALTH LLCITQ2025-07-08
10810113579945ViveVIVE HEALTH LLCITQ2025-07-08
10810113579952ViveVIVE HEALTH LLCITQ2025-07-08
00190446660545PROCAREDJO, LLCITQ2025-07-07