FDA.reportPublic FDA data

Lode B.V.

Primary DI
08717524640712
Brand
Lode B.V.
Company
Lode B.V.
Model
969900
Device description
969900 Corival Recumbent cpet
Published
2018-01-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
ISDExerciser, measuring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISDExerciser, MeasuringPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K851097000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K851097000LODE MODEL CORIVAL ERGOMETERLode Corp.1985-06-18ISD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08717524640712PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717524640712087175246407128717524640712

GMDN Terms#

Term, Definition table
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
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08717524640392Lode B.V.9379012017-05-09
08717524640064Lode B.V.9389002017-05-09
08717524640071Lode B.V.9389012017-05-10
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
08717524641054Lode B.V.9259002019-08-09
08717524641061Lode B.V.9259092019-08-09
08717524640026Lode B.V.9609002017-05-08
08717524640033Lode B.V.9609012017-05-09
08717524640057Lode B.V.9609122017-05-09
08717524640187Lode B.V.9299002017-05-11
08717524640484Lode B.V.9679002018-02-01
08717524640491Lode B.V.9679022018-02-01
08717524640507Lode B.V.9679032018-02-01
08717524640514Lode B.V.9679042018-02-01

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