FDA.reportPublic FDA data

HealthSmart

Primary DI
00041298370093
Brand
HealthSmart
Company
D-M-S HOLDINGS, INC.
Model
522-3700-1900
Device description
Fold-Away Wall Mount Shower Seat
Published
2023-07-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
INBAttachment, Commode, Wheelchair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INBAttachment, Commode, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10041298370090PackageGS12In Commercial Distribution
00041298370093PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1004129837009010041298370090
00041298370093000412983700930412983700930041298370093

GMDN Terms#

Term, Definition table
TermDefinition
Shower seat, non-poweredA non-powered device designed to be sat upon by a patient (adult or child) while washing in a shower, or other washing facility (e.g., bath). The patient is typically disabled, infirm, or is undergoing medical treatment and requires to be seated while bathing/showering. The device may be in the form of a portable chair/stool or a fixed seat (e.g., wall-mounted), and may include armrests, side supports, or grab handles; it is typically made of water-resistant or waterproof materials (e.g., plastic and metal-coated materials). It may be used in a hospital, institution, or home.

Regulatory Flags#

DUNS number
062028220
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00767056160026MABIS01-160-02101-160-0212016-09-23
00767056160088MABIS01-160-08101-160-0812016-09-23
00767056160156MABIS01-160-15101-160-1512016-09-23
00767056160200MABIS01-160-20101-160-2012016-09-23
00767056160217MABIS01-160-21101-160-2112016-09-23
00767056160248MABIS01-160-24101-160-2412016-09-23
00767056410176MABIS09-141-01709-141-0172016-09-23
00767056110212MABIS01-110-02101-110-0212016-09-23
00767056234017MABIS05-234-01005-234-0102016-09-23
00767056300118MABIS01-130-01101-130-0112016-09-23
00767056300156MABIS01-130-01501-130-0152016-09-23
00767056300163MABIS01-130-01601-130-0162016-09-23
00767056322059MABIS05-223-06005-223-0602016-09-23
00767056400115MABIS01-140-01101-140-0112016-09-23
00767056400139MABIS01-140-01301-140-0132016-09-23
00767056400153MABIS01-140-01501-140-0152016-09-23
00767056400160MABIS01-140-01601-140-0162016-09-23
00767056400177MABIS01-140-01701-140-0172016-09-23
00767056550117MABIS01-155-01101-155-0112016-09-23
00767056600119MABIS05-260-01105-260-0112016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810178887644ViveVIVE HEALTH LLCINB2026-04-27
00810178884476ViveVIVE HEALTH LLCINB2026-02-02
00810178883806Vive VIVE HEALTH LLCINB2026-01-30
00860014905216MultichairNuprodx, Inc.INB2026-01-27
20885380068321CARDINAL HEALTHCardinal Health 200, LLCINB2025-12-29
50885380068322CARDINAL HEALTHCardinal Health 200, LLCINB2025-12-29
00815027012826DALTON COMMODE CHAIRDALTON MEDICAL CORPORATIONINB2025-09-18
00815027012833DALTON COMMODE CHAIRDALTON MEDICAL CORPORATIONINB2025-09-18
00815027012840DALTON TOILET SEATDALTON MEDICAL CORPORATIONINB2025-09-18
06970289035847HetaidaHetaida Technology Co., LtdINB2025-05-12
16970289035844HetaidaHetaida Technology Co., LtdINB2025-05-12
00194346231423Parent's ChoiceWAL-MART STORES, INC.INB2024-10-29
10194346231420Parent's ChoiceWAL-MART STORES, INC.INB2024-10-29
06976203345221GilogaZhongshan Jiale Rehabilitation Medical Equipment Co., LtdINB2024-07-01
06970289035649HetaidaHetaida Technology Co., LtdINB2024-03-14
16970289035646HetaidaHetaida Technology Co., LtdINB2024-03-14
00810113574219ViveVIVE HEALTH LLCINB2024-01-05
10041298370090HealthSmartD-M-S HOLDINGS, INC.INB2023-07-24
00822383008325DriveDrive Devilbiss HealthcareINB2022-02-01
50822383008320DriveDrive Devilbiss HealthcareINB2022-02-01
M3682195A41LUMEX GF HEALTH PRODUCTS, INC.INB2021-07-14
M3682215B21LUMEX GF HEALTH PRODUCTS, INC.INB2021-07-14
M3682195A40LUMEX GF HEALTH PRODUCTS, INC.INB2021-07-14
M3682215B20LUMEX GF HEALTH PRODUCTS, INC.INB2021-07-14
M368603904A1LUMEX GF HEALTH PRODUCTS, INC.INB2021-07-14
M36890761752J1Everest & JenningsGF HEALTH PRODUCTS, INC.INB2020-12-09
M3689B007700J1Everest & JenningsGF HEALTH PRODUCTS, INC.INB2020-12-09
M3689B045035J1Everest & JenningsGF HEALTH PRODUCTS, INC.INB2020-12-09
M3689B232870J1Everest & JenningsGF HEALTH PRODUCTS, INC.INB2020-12-09
M3689B47320J1Everest & JenningsGF HEALTH PRODUCTS, INC.INB2020-12-09