FDA.report

Lode B.V.

Primary DI
08717524641061
Brand
Lode B.V.
Company
Lode B.V.
Model
965920
Device description
965920 Excalibur Sport PFM
Published
2019-08-09
Public version status
Update
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
ISDExerciser, measuring

Product Code Classifications

CodeDeviceSpecialtyClass
ISDExerciser, MeasuringPhysical Medicine2

Premarket Submissions

SubmissionSupplement
K851097000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K851097000LODE MODEL CORIVAL ERGOMETERLode Corp.1985-06-18ISD

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08717524641061PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08717524641061087175246410618717524641061

GMDN Terms

TermDefinition
Bicycle ergometerA device intended to be used to provide a quantitative measurement of the rate at which work (energy) is performed by a muscle or group of muscles under controlled conditions. It is operated by a person using their legs, usually the patient, undergoing assessment, treatment, training, or rehabiltation and measures this related muscle activity at defined workloads.

Regulatory Flags

DUNS number
407774181
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08717524640194Lode B.V.9259002017-05-09
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08717524640217Lode B.V.9259012017-05-09
08717524640224Lode B.V.9259102017-05-09
08717524640064Lode B.V.9389002017-05-09
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08717524640088Lode B.V.9389032017-05-10
08717524640095Lode B.V.9389042017-05-10
08717524640101Lode B.V.9389052017-05-10
08717524640118Lode B.V.9389062017-05-11
08717524640156Lode B.V.9389022017-05-11
08717524640163Lode B.V.9349302017-05-11
08717524640170Lode B.V.9349002017-05-11

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