FDA.reportPublic FDA data

Bio Leg™

Primary DI
00860010894811
Brand
Bio Leg™
Company
BIONICM INC.
Model
SN007
Device description
Robotic prosthetic leg - black - large - robotic knee joint only
Published
2024-05-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
ISWAssembly, Knee/Shank/Ankle/Foot, External

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISWAssembly, Knee/Shank/Ankle/Foot, ExternalPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860010894811PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010894811008600108948118600108948110860010894811

GMDN Terms#

Term, Definition table
TermDefinition
Mechatronic external knee prosthesisA battery-powered electromechanical device which is a component of an external lower limb prosthesis designed to functionally replace, in part or total, an absent knee, wherein the principle of operation for motion control is based on hydraulic, pneumatic, or magnetorheological actuation regulated by a motion-feedback mechanism using electronic sensors and software. It is intended to respond to changes in motion in real-time by continuously sensing knee flexion speed and temperature and instantly adjusting motion resistance within a single step. Known as a microprocessor-controlled knee (MPK), it may have various designs and functional features for support during a variety of activities.

Regulatory Flags#

DUNS number
717916018
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
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
00860010894842Bio Leg™BLP001L2025-08-21
00860010894859Bio Leg™BLP001T2025-08-21
00860010894804Bio Leg™BLP0012024-05-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850004761106WalkasinsRxFunction, Inc.ISW2026-06-24
00850004761113WalkasinsRxFunction, Inc.ISW2026-06-24
00850004761120WalkasinsRxFunction, Inc.ISW2026-06-24
00850004761137WalkasinsRxFunction, Inc.ISW2026-06-24
00850004761144WalkasinsRxFunction, Inc.ISW2026-06-24
00850004761151WalkasinsRxFunction, Inc.ISW2026-06-24
00850004761168WalkasinsRxFunction, Inc.ISW2026-06-24
00850004761175WalkasinsRxFunction, Inc.ISW2026-06-24
00860010894842Bio Leg™BIONICM INC.ISW2025-08-21
00860010894859Bio Leg™BIONICM INC.ISW2025-08-21
00860010894804Bio Leg™BIONICM INC.ISW2024-05-24
04032767811571BiOM T2OTTO BOCK HEALTHCAREISW2018-04-11
04032767811588BiOM T2OTTO BOCK HEALTHCAREISW2018-04-11
04032767832842EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767832866EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767838882EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767838899EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767838905EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767838912EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767838929EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767838936EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767838943EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767838950EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767838967EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767838974EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767838981EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767838998EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767839001EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767839018EmpowerOTTO BOCK HEALTHCAREISW2018-04-11
04032767839025EmpowerOTTO BOCK HEALTHCAREISW2018-04-11