FDA.reportPublic FDA data

Lode B.V.

Primary DI
08717524641092
Brand
Lode B.V.
Company
Lode B.V.
Model
965921
Device description
Brachumera Sport PFM
Published
2026-06-01
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

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
08717524641092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717524641092087175246410928717524641092

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
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08717524641085Lode B.V.9659112026-06-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05065013876061Sword ThriveSWORD HEALTH, S.A.ISD2026-06-02
08717524641085Lode B.V.Lode B.V.ISD2026-06-01
07649998859059NUSHUMagnes AGISD2026-05-31
07290016986211XRBehaviorXR HEALTH IL LTDISD2026-05-14
07290016986204XRBehaviorXR HEALTH IL LTDISD2026-05-04
00199874272399SeniorLife.AISENIORLIFE TECHNOLOGIES INC.ISD2026-03-11
00850000967649SpiroFitCMI HEALTH INC.ISD2026-03-06
00853858006522EmbraceMiniEMPATICA SRLISD2026-02-16
00853858006713EmbraceMiniEMPATICA SRLISD2026-02-16
07290016986174XRBehaviorXR HEALTH IL LTDISD2026-01-26
07290016986181XRBehaviorXR HEALTH IL LTDISD2026-01-26
00860014763700Aspire MotionSurge Motion Inc.ISD2025-11-14
G186EXERSCAN30Exer ScanExer Labs, Inc.ISD2025-11-10
00860004615606XR Therapy SystemNeuromersive, Inc.ISD2025-10-25
00810188050045Bioness Integrated Therapy System, BITS 3.0, BITS BalanceBioness Medical, Inc.ISD2025-07-18
00616784050218Pedal Exerciser, Folding, Digital, Hands/FeetDynarex CorporationISD2025-05-29
00850064651102DS6Foresite Healthcare, LLCISD2025-02-07
G741WHREHABV10Waya RehabWELLOVATE, LLCISD2025-02-03
00860010613320StrideLink MercuryStrideLink Inc.ISD2024-12-16
G186EXERSCAN20Exer ScanExer Labs, Inc.ISD2024-09-03
00850067173007Opal V2CAPDM WEARABLE TECHNOLOGIES, INC.ISD2024-08-30
00850067173014Docking Station V2CAPDM WEARABLE TECHNOLOGIES, INC.ISD2024-08-30
00850067173021Access Point V2CAPDM WEARABLE TECHNOLOGIES, INC.ISD2024-08-30
00850067173038Opal DataHub V2CAPDM WEARABLE TECHNOLOGIES, INC.ISD2024-08-30
00850064651003DS5Foresite Healthcare, LLCISD2024-05-24
00850064651010DS6Foresite Healthcare, LLCISD2024-05-24
00850064651027MDSForesite Healthcare, LLCISD2024-05-24
00850064651041DS6Foresite Healthcare, LLCISD2024-05-24
00850064651058DS6Foresite Healthcare, LLCISD2024-05-24
00850064651065DS6Foresite Healthcare, LLCISD2024-05-24