FDA.reportPublic FDA data

HealthSmart

Primary DI
10041298370090
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
Rx
false
OTC
false
Sterile
false
Single use
false

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
062028220
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
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
00041298370093HealthSmartD-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