FDA.report

DeRoyal

Primary DI
00749756580069
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
9357-20
Catalog number
9357-20
Device description
CPM REPLACEMENT PAD
Published
2021-07-29
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
false

Related Records

Contact Domains

Product Codes

CodeName
BXBEXERCISER, POWERED

Product Code Classifications

CodeDeviceSpecialtyClass
BXBExerciser, PoweredPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00749756580069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00749756580069007497565800697497565800690749756580069

GMDN Terms

TermDefinition
Hip/knee continuous passive motion exerciserA mains electricity (AC-powered) device intended to provide continuous passive motion (CPM) exercise therapy for the hip and/or knee, typically following joint surgery/trauma to promote healing; some types may also operate with patient assistance under controlled active motion (CAM). The device may stimulate articular tissues, circulation of synovial fluid, reduce joint oedema, and provide neuromuscular and coordination training. It typically consists of a motorized carriage with straps to hold and move the leg/knee, and an electrical control unit for the healthcare professional to set the motion range/speed; digital displays and manual/automated safety capabilities may also be included.

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

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00749756399333DeRoyal1-524A-01-CHO1-524A-01-CHO2025-07-30
00749756399340DeRoyal1-524A-02-CHO1-524A-02-CHO2025-07-30
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