FDA.reportPublic FDA data

Handicare

Primary DI
00810045517520
Brand
Handicare
Company
HANDICARE USA, INC.
Model
520547080-10
Device description
Custom Disposable Universal Sling w_HS - XL (Case 10)
Published
2024-10-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
INESling, Overhead Suspension, Wheelchair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INESling, Overhead Suspension, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810045517568PrimaryGS10
00810045517520Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810045517568008100455175688100455175680810045517568
00810045517520008100455175208100455175200810045517520

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
800145836
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810045517612Handicare520517340-12026-06-10
00810045517582Handicare5208A1200-S2025-08-13
00810045517599Handicare5208A1500-S2025-08-13
00810045517605Handicare5208A1600-S2025-08-13
00810045512785Handicare3030802020-12-14
00810045510040Handicare3030702020-07-02
00810045510385Handicare3030602020-07-02
00810045510392Handicare3030732020-07-02
00810045510408Handicare3030752020-07-02
00810045510415Handicare3030772020-07-02
00810045510422Handicare3030902020-07-02
00810045510439Handicare3030912020-07-02
00810045510446Handicare3030932020-07-02
00810045512808Handicare3030742020-07-02
00810045517575Handicare5204024552025-05-09
00810045517537Handicare520547050-102024-10-11
00810045517544Handicare520547060-102024-10-11
00810045517551Handicare520547070-102024-10-11
00810045517568Handicare520547080-102024-10-11
00810045517490Handicare520547050-102024-10-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810045517612HandicareHANDICARE USA, INC.INE2026-06-10
05056387401836Silvalea Boned Back Stand aid poly loops LARGESILVALEA LIMITEDINE2025-03-13
05056387401850Silvalea Boned Back Stand aid poly loops MEDIUMSILVALEA LIMITEDINE2025-03-13
05056387401898Silvalea Boned Back Stand aid poly loops EXTRA LARGESILVALEA LIMITEDINE2025-03-13
05056387438900In-Situ Repositioning Sheet MediumSILVALEA LIMITEDINE2024-07-29
05056387438917In-Situ Repositioning Sheet LargeSILVALEA LIMITEDINE2024-07-29
05056387415864Disposable High Easy LOOPS LargeSILVALEA LIMITEDINE2024-03-11
05056387415871Disposable High Easy Poly LOOPS LargeSILVALEA LIMITEDINE2024-03-11
05056387415888Disposable High Easy LOOPS MEDIUMSILVALEA LIMITEDINE2024-03-11
05056387415895Disposable High Easy Poly LOOPS MediumSILVALEA LIMITEDINE2024-03-11
05056387415901Disposable High Easy LOOPS SmallSILVALEA LIMITEDINE2024-03-11
05056387415918Disposable High Easy LOOPS Extra LargeSILVALEA LIMITEDINE2024-03-11
05056387415925Disposable High Easy LOOPS Extra SmallSILVALEA LIMITEDINE2024-03-11
05056387415932Disposable High Easy LOOPS XXLargeSILVALEA LIMITEDINE2024-03-11
05056387437040Repositioning Sheet Close Weave PolyesterSILVALEA LIMITEDINE2024-02-29
05056387403823General Stand Aid Sling D-A Clips White Extra LargeSILVALEA LIMITEDINE2024-02-28
05056387405148Birthing Sling ManualSILVALEA LIMITEDINE2024-02-28
05056387409245Stand Assist Clip Fixings LargeSILVALEA LIMITEDINE2024-02-28
05056387409252Stand Assist Loop Fixings LargeSILVALEA LIMITEDINE2024-02-28
05056387409269Stand Assist Clip Fixings MediumSILVALEA LIMITEDINE2024-02-28
05056387409276Stand Assist Loop Fixings MediumSILVALEA LIMITEDINE2024-02-28
05056387409283Stand Assist Clip Fixings SmallSILVALEA LIMITEDINE2024-02-28
05056387409290Stand Assist Loop Fixings SmallSILVALEA LIMITEDINE2024-02-28
05056387409306Stand Assist Clip Fixings Extra LargeSILVALEA LIMITEDINE2024-02-28
05056387409313Stand Assist Loop Fixings Extra LargeSILVALEA LIMITEDINE2024-02-28
05056387409320Stand Assist Clip Fixings Extra SmallSILVALEA LIMITEDINE2024-02-28
05056387409337Stand Assist Loop Fixings Extra SmallSILVALEA LIMITEDINE2024-02-28
05056387409344Stand Assist Clip Fixings Ex Ex LargeSILVALEA LIMITEDINE2024-02-28
05056387409351Stand Assist Loop Fixings Ex Ex LargeSILVALEA LIMITEDINE2024-02-28
05056387409368Stand Assist Loop Fixings Ex Ex Ex LargeSILVALEA LIMITEDINE2024-02-28