FDA.report

DeRoyal

Primary DI
00749756141192
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
1203-50
Catalog number
1203-50
Device description
Resistive Exercise Band
Published
2021-07-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
IONEXERCISER, NON-MEASURING

Product Code Classifications

CodeDeviceSpecialtyClass
IONExerciser, Non-MeasuringPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00749756141192PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00749756141192007497561411927497561411920749756141192

GMDN Terms

TermDefinition
Body elastic exerciserAn exercise apparatus intended to primarily strengthen several or all of the major muscle groups of the body (i.e., in the arms, legs, chest, back, and/or abdomen) through repetitive body motion against elastic resistance. It typically consists of elastic bands, tubes, or cables often with handles/grips and sometimes anchors for attachment to fixtures (e.g., doors). The device typically enables the performance of a wide variety of exercise motions including curls, presses, lunges, flies, and raises; it may also be used to improve body flexibility and mobility.

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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