FDA.report

DeRoyal

Primary DI
00749756111492
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
M5150
Catalog number
M5150
Device description
Wheelchair Belt
Published
2021-08-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KIDRESTRAINT, WHEELCHAIR, NON-PROTECTIVE

Product Code Classifications

CodeDeviceSpecialtyClass
KIDRestraint, Wheelchair, Non-ProtectivePhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00749756111492PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00749756111492007497561114927497561114920749756111492

GMDN Terms

TermDefinition
Wheelchair/chair occupant restraint/supportA rigid or non-rigid device, typically a strap, belt, bar, harness or vest designed to be attached to a wheelchair/chair and/or its occupant to stabilize the occupant’s position for prevention of slips and/or falls from the appliance and/or to provide postural support. Some types may also be used to secure a wheelchair occupant in a wheelchair while travelling in a motor vehicle.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(888)938-7828udisupport@deroyal.com

Regulatory Flags

DUNS number
096372255
Device count
1
DM exempt
true
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
true
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 DIBrandModelCatalogPublished
50749756033140DeRoyal10-513010-51302023-01-31
50749756392490DeRoyalNP-6006UNP-6006U2026-01-22
50749756397808DeRoyalNP-0080LMDNP-0080LMD2026-01-22
00749756401258DeRoyalSTM2000STM20002026-01-22
50749756401352DeRoyalM60-AP500M60-AP5002026-01-22
50749756401376DeRoyalM60-AP600M60-AP6002026-01-22
50749756401383DeRoyalM60-AP601M60-AP6012026-01-22
50749756401390DeRoyalM60-AP602M60-AP6022026-01-22
50749756401482DeRoyal46-LT19S-01B46-LT19S-01B2026-01-22
50749756401437DeRoyalM70-200PM70-200P2026-01-01
50749756401444DeRoyalM70-200CM70-200C2026-01-01
50749756401451DeRoyalM70-200CNWM70-200CNW2026-01-01
50749756401468DeRoyalM70-200PNWM70-200PNW2026-01-01
50749756394418DeRoyal71-080571-08052025-08-13
50749756396641DeRoyalPH81-010400PH81-0104002025-08-13
50749756397853DeRoyalPH81-020409PH81-0204092025-08-13
50749756397860DeRoyalPH81-020412PH81-0204122025-08-13
00749756399333DeRoyal1-524A-01-CHO1-524A-01-CHO2025-07-30
00749756399340DeRoyal1-524A-02-CHO1-524A-02-CHO2025-07-30
00749756399357DeRoyal1-524A-03-CHO1-524A-03-CHO2025-07-30

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00860011289296ValmaxSupply Line MedicalKID2025-02-21
06974231101307ValmaxSupply Line MedicalKID2025-01-21
00749756011426DeRoyalDEROYAL INDUSTRIES, INC.KID2021-08-03
50749756011490DeRoyalDEROYAL INDUSTRIES, INC.KID2021-08-03
00749756011525DeRoyalDEROYAL INDUSTRIES, INC.KID2021-08-03
00749756011549DeRoyalDEROYAL INDUSTRIES, INC.KID2021-08-03
00749756011563DeRoyalDEROYAL INDUSTRIES, INC.KID2021-08-03
00749756111515DeRoyalDEROYAL INDUSTRIES, INC.KID2021-08-03
00749756112345DeRoyalDEROYAL INDUSTRIES, INC.KID2021-08-03
00749756128964DeRoyalDEROYAL INDUSTRIES, INC.KID2021-08-03
00749756780162DeRoyalDEROYAL INDUSTRIES, INC.KID2021-08-03
08436035353286Salvaclip ComfortMEDI CARE SYSTEM SLUKID2019-11-26
08436035351145SalvaclipMEDI CARE SYSTEM SLUKID2019-11-22
08436035351169SalvaclipMEDI CARE SYSTEM SLUKID2019-11-22
08436035351183SalvaclipMEDI CARE SYSTEM SLUKID2019-11-22
08436035351206SalvaclipMEDI CARE SYSTEM SLUKID2019-11-22
08436035351220SalvaclipMEDI CARE SYSTEM SLUKID2019-11-22
08436035351244SalvaclipMEDI CARE SYSTEM SLUKID2019-11-22
08436035351268SalvaclipMEDI CARE SYSTEM SLUKID2019-11-22
08436035351282SalvaclipMEDI CARE SYSTEM SLUKID2019-11-22
08436035351305SalvaclipMEDI CARE SYSTEM SLUKID2019-11-22
08436035351329SalvaclipMEDI CARE SYSTEM SLUKID2019-11-22
08436035351343SalvaclipMEDI CARE SYSTEM SLUKID2019-11-22
08436035351367SalvaclipMEDI CARE SYSTEM SLUKID2019-11-22
08436035351381SalvaclipMEDI CARE SYSTEM SLUKID2019-11-22
08436035351442SalvaclipMEDI CARE SYSTEM SLUKID2019-11-22
08436035351480SalvaclipMEDI CARE SYSTEM SLUKID2019-11-22
08436035353262Salvaclip ComfortMEDI CARE SYSTEM SLUKID2019-11-22
08436035353279Salvaclip ComfortMEDI CARE SYSTEM SLUKID2019-11-22
08436035353293Salvaclip ComfortMEDI CARE SYSTEM SLUKID2019-11-22