FDA.report

BiOM T2

Primary DI
B15520017930
Brand
BiOM T2
Company
OTTO BOCK HEALTHCARE
Model
757L37
Device description
BiOM T2 Charger
Published
2018-04-11
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
ISWAssembly, Knee/Shank/Ankle/Foot, External

Product Code Classifications

CodeDeviceSpecialtyClass
ISWAssembly, Knee/Shank/Ankle/Foot, ExternalPhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04032767811588PrimaryGS10
B15520017930PrimaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04032767811588040327678115884032767811588

GMDN Terms

TermDefinition
Noninvasive device battery chargerAn electrically-powered device designed to supply an electrical charge, via a direct/wired or wireless connection, to the battery of a noninvasive device to recharge it for operation; it is not intended to receive data from and transmit data to other devices (i.e., not a transceiver). It is typically in the form of an electronic circuitry housing with a cable.

Sterilization Methods

Method

Regulatory Flags

DUNS number
932133408
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04032767832859Empower757B382018-04-11
04064409000012MyCRO Band24H1=12021-03-29
04064409000029MyCRO Band24H1=112021-03-29
04064409000036MyCRO Band24H1=122021-03-29
04064409000043MyCRO Band24H1=132021-03-29
04064409000050MyCRO Band24H1=2.52021-03-29
04064409000067MyCRO Band24H1=32021-03-29
04064409000074MyCRO Band24H1=52021-03-29
04064409000081MyCRO Band24H1=72021-03-29
04064409000098MyCRO Band24H1=82021-03-29
04064409000104MyCRO Band24H1=92021-03-29
04064409002634Empower1A1-2=L25-3/152021-03-01
04064409002641Empower1A1-2=L25-3/42021-03-01
04064409002658Empower1A1-2=L25-4/152021-03-01
04064409002665Empower1A1-2=L25-4/42021-03-01
04064409002672Empower1A1-2=L25-5/152021-03-01
04064409002689Empower1A1-2=L25-5/42021-03-01
04064409002696Empower1A1-2=L25-6/152021-03-01
04064409002702Empower1A1-2=L25-6/42021-03-01
04064409002719Empower1A1-2=L26-3/152021-03-01

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00860010894842Bio Leg™BIONICM INC.ISW2025-08-21
00860010894859Bio Leg™BIONICM INC.ISW2025-08-21
00860010894804Bio Leg™BIONICM INC.ISW2024-05-24
00860010894811Bio Leg™BIONICM INC.ISW2024-05-24
05690967648749Power KneeOSSUR AMERICAS, INC.ISW2022-07-08
05690967642822Power KneeOSSUR AMERICAS, INC.ISW2021-03-12
05690967642839Power KneeOSSUR AMERICAS, INC.ISW2021-03-12
05690967648381Power KneeOSSUR AMERICAS, INC.ISW2021-03-12
05690967648404Power KneeOSSUR AMERICAS, INC.ISW2021-03-12
04064409002634EmpowerOTTO BOCK HEALTHCAREISW2021-03-01
04064409002641EmpowerOTTO BOCK HEALTHCAREISW2021-03-01
04064409002658EmpowerOTTO BOCK HEALTHCAREISW2021-03-01
04064409002665EmpowerOTTO BOCK HEALTHCAREISW2021-03-01
04064409002672EmpowerOTTO BOCK HEALTHCAREISW2021-03-01
04064409002689EmpowerOTTO BOCK HEALTHCAREISW2021-03-01
04064409002696EmpowerOTTO BOCK HEALTHCAREISW2021-03-01
04064409002702EmpowerOTTO BOCK HEALTHCAREISW2021-03-01
04064409002719EmpowerOTTO BOCK HEALTHCAREISW2021-03-01
04064409002726EmpowerOTTO BOCK HEALTHCAREISW2021-03-01
04064409002733EmpowerOTTO BOCK HEALTHCAREISW2021-03-01
04064409002740EmpowerOTTO BOCK HEALTHCAREISW2021-03-01
04064409002757EmpowerOTTO BOCK HEALTHCAREISW2021-03-01
04064409002764EmpowerOTTO BOCK HEALTHCAREISW2021-03-01
04064409002771EmpowerOTTO BOCK HEALTHCAREISW2021-03-01
04064409002788EmpowerOTTO BOCK HEALTHCAREISW2021-03-01
04064409002795EmpowerOTTO BOCK HEALTHCAREISW2021-03-01
04064409002801EmpowerOTTO BOCK HEALTHCAREISW2021-03-01
04064409002818EmpowerOTTO BOCK HEALTHCAREISW2021-03-01
04064409002825EmpowerOTTO BOCK HEALTHCAREISW2021-03-01
04064409002832EmpowerOTTO BOCK HEALTHCAREISW2021-03-01