FDA.report

WORK HARDENING STARTUP PACKAGE

Primary DI
00840314806475
Brand
WORK HARDENING STARTUP PACKAGE
Company
Hausmann Enterprises, LLC
Model
SYSTEM-I
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
00840314806475PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840314806475008403148064758403148064750840314806475

GMDN Terms

TermDefinition
Chest-press exerciserA mechanical exercise apparatus primarily intended to strengthen the muscles of the chest (especially the pectoralis major) through a repetitive pushing or pulling motion performed with the arms against the force of a weight. It typically consists of a metal frame containing a lever or pulley-cable system that incorporates changeable weights and bars and/or handles/hand stirrups for the user to grip and push or pull; also typically included is a bench for the user to sit or lay while performing the exercise (some exercises referred to as bench press). The device may also be used to help strengthen other upper-body muscles (e.g., deltoids, biceps, triceps).

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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