FDA.reportPublic FDA data

THIN GAIT BELT 54 INCH

Primary DI
00733657232141
Brand
THIN GAIT BELT 54 INCH
Company
ALIMED, INC.
Model
712437
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
IKXAID, TRANSFER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKXAid, TransferPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00733657232141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00733657232141007336572321417336572321410733657232141

GMDN Terms#

Term, Definition table
TermDefinition
Movement-resistance gait rehabilitation deviceA collection of wearable belts, vest, straps and pulleys designed to assist a patient with a walking disability (neurogenic, muscular, or osseous in origin) with regaining lost motor function for ambulation using movement-resistant attachments to the legs/feet. This is a non-powered device intended to be used in the home.

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

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00850015884986easycareSynchronis Medical, LLCIKX2026-02-20
00850063404006easycareSynchronis Medical, LLCIKX2026-02-20
00850063404020easycareSynchronis Medical, LLCIKX2026-02-20
00850063404044easycareSynchronis Medical, LLCIKX2026-02-20
00860000925303easycareSynchronis Medical, LLCIKX2026-02-20
00850063404068easycareSynchronis Medical, LLCIKX2026-02-13
00850063404082easycareSynchronis Medical, LLCIKX2026-02-13
00850063404105easycareSynchronis Medical, LLCIKX2026-02-13
00850063404129easycareSynchronis Medical, LLCIKX2026-02-13
00850063404143easycareSynchronis Medical, LLCIKX2026-02-13
00850063404167easycareSynchronis Medical, LLCIKX2026-02-13
00850063404181easycareSynchronis Medical, LLCIKX2026-02-13
10810132043007HCSConcordance Healthcare Solutions LLCIKX2026-01-23
10810132043014HCSConcordance Healthcare Solutions LLCIKX2026-01-23
00745129273859579 Melany Donning & Doffing SmallSIGVARIS INCIKX2026-01-19
00745129273866579 Melany Donning & Doffing Extra SmallSIGVARIS INCIKX2026-01-19
00745129273835579 Melany Donning & Doffing LargeSIGVARIS INCIKX2026-01-09
00745129273842579 Melany Donning & Doffing MEDIUMSIGVARIS INCIKX2026-01-09
00810178884940ViveVIVE HEALTH LLCIKX2026-01-08
00810178885015ViveVIVE HEALTH LLCIKX2026-01-08
10810178884206ViveVIVE HEALTH LLCIKX2025-12-06
00810178884582ViveVIVE HEALTH LLCIKX2025-12-05
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00841027102458Pedigo Products, Inc. PEDIGO PRODUCTS, INC.IKX2025-11-26
00841027102465Pedigo Products, Inc. PEDIGO PRODUCTS, INC.IKX2025-11-26
00841027102632Pedigo Products, Inc. PEDIGO PRODUCTS, INC.IKX2025-11-26