FDA.report

STAIRS,ADA STRAIGHT,11" DEEP STEP

Primary DI
00840314803986
Brand
STAIRS,ADA STRAIGHT,11" DEEP STEP
Company
Hausmann Enterprises, LLC
Model
1582
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
IONExerciser, Non-Measuring

Product Code Classifications

CodeDeviceSpecialtyClass
IONExerciser, Non-MeasuringPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840314803986PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840314803986008403148039868403148039860840314803986

GMDN Terms

TermDefinition
Stair-climbing exerciser, non-poweredAn exercise apparatus designed to simulate the motion of climbing stairs primarily to increase cardiovascular endurance by keeping the heart and respiration rates elevated over a continuous period (aerobics); it also promotes lower-body muscle strength. It may consist of static staircases, or steppers (also known as climbers) consisting of foot pedals or platforms with a manual/hydraulic/air piston drive system, and with side handrails and/or front handlebars. It may include workout program modes to adjust the resistance level, a monitor to display the workout time, distance, speed, calories burned, and heart rate; and handlebars with grip pulse sensors or wireless heart rate tools.

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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00840314811189ELASTIC ANKLE SUPPORT LGHM01322025-01-01
00840314811196ELASTIC ANKLE SUPPORT XLHM01332025-01-01
00840314811202ELASTIC ELBOW SUPPORT SMHM01342025-01-01
00840314811219ELASTIC ELBOW SUPPORT MDHM01352025-01-01
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00840314811233ELASTIC ELBOW SUPPORT XLHM01372025-01-01
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