FDA.report

HUGGER WT SET,5 WEIGHTS,1-5LB

Primary DI
00840314809483
Brand
HUGGER WT SET,5 WEIGHTS,1-5LB
Company
Hausmann Enterprises, LLC
Model
5588
Published
2022-08-16
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

Related Records

Product Codes

CodeName
IODComponents, Exercise

Product Code Classifications

CodeDeviceSpecialtyClass
IODComponents, ExercisePhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840314809483PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840314809483008403148094838403148094830840314809483

GMDN Terms

TermDefinition
Hand-held free weight exerciserA piece of exercise equipment designed primarily to increase muscle strength especially of the upper body by repetitive lifting and lowering with the hands and arms. It may be one of several types of hand-held weights or masses that are not attached to another structural device, including barbells, dumbbells, kettlebells, weight bars, weight plates, and medicine balls. The device is intended to improve strength especially in the arms, wrists, shoulders, chest, and back; it may also be used to help improve lower-body muscle strength and improve body metabolic rate, balance, flexibility, mobility, and bone density.

Sterilization Methods

Method

Regulatory Flags

DUNS number
001892660
Device count
1
DM exempt
false
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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