FDA.report

Health o meter professional

Primary DI
00851628008387
Brand
Health o meter professional
Company
Pelstar, LLC
Model
2600KG-BT
Device description
HOM Wheelchair Scale, KG only with BT
Published
2022-02-07
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
INFScale, Platform, Wheelchair

Product Code Classifications

CodeDeviceSpecialtyClass
INFScale, Platform, WheelchairPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00851628008387PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00851628008387008516280083878516280083870851628008387

GMDN Terms

TermDefinition
Wheelchair-accessible platform scaleAn electronic device designed to measure the weight of a wheelchair occupant who is unable to vacate their wheelchair; it may in addition be intended to function as a patient stand-on scale. It is designed as a floor-standing or floor-integrated platform whereby the known weight of the wheelchair is subtracted from the total measured weight to provide the weight of the wheelchair occupant; it is not designed to weigh a bed/stretcher.

Sterilization Methods

Method

Regulatory Flags

DUNS number
037289290
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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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00850017694330Health o meter professional59002022-11-16
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00850017694118Health o meter professional523KL2022-03-30
00850017694187Health o meter professional752KL-BT2022-03-30
00850017694194Health o meter professional752KG-BT2022-03-30
00850017694750Health o meter professional880KG2022-03-30
00851628008042Health o meter professional550KL2022-03-30
00851628008073Health o meter professional596KL2022-03-30
00851628008646Health o meter professional599KG2022-03-30
00851628008653Health o meter professional600KG2022-03-30
00851628008660Health o meter professional752KG2022-03-30
00851628008677Health o meter professional600KG-BT2022-03-30
00851628008752Health o meter professional844KL-C2022-03-30

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