FDA.report

Project Source

Primary DI
30076855990002
Brand
Project Source
Company
COMPASS HEALTH BRANDS CORP.
Model
FGB753PS LWS
Device description
PS BATH & SHOWER SEAT W/BACK
Published
2022-12-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
ILSAdaptor, Hygiene

Product Code Classifications

CodeDeviceSpecialtyClass
ILSAdaptor, HygienePhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30076855990002PackageGS11In Commercial Distribution
00076855990001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
3007685599000230076855990002
00076855990001000768559900010768559900010076855990001

GMDN Terms

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

Contacts

PhoneEmail
800-376-7263customerservice@compasshealthbrands.com

Regulatory Flags

DUNS number
827221698
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

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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06975960550671VOCICZhejiang Mateside Medical Devices Technology Co., LtdILS2026-03-17
00810178886012ViveVIVE HEALTH LLCILS2026-02-03
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06979196000016Shower chairZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000023Shower chairZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000030Shower chairZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000047Shower chairZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000054Shower chairZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000061Shower chairZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000078Shower chairZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000085Shower chairZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000092Shower chairZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000108Shower chairZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000115Shower chairZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000122Shower chairZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000139Shower chairZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000146Shower chairZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000153Shower chairZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000160Shower chairZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000177Shower chairZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000184Shower chairZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000191Shower chairZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000207Shower chairZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000214Shower chairZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000221Toilet SeatZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000238Toilet SeatZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000245Toilet SeatZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000252Toilet seatZhongshan Yungu daily products Co., LTD.ILS2025-12-18
06979196000269Toilet seatZhongshan Yungu daily products Co., LTD.ILS2025-12-18