Glide (91000-GL-X)
Infinite Biomedical Technologies, LLC
INFINITE BIOMEDICAL TECHNOLOGIES, LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3004426795 | 3004426795 | INFINITE BIOMEDICAL TECHNOLOGIES, LLC | 1 | N | 2026-01-01 | 8 Market Place Suite 500 Baltimore MD US 21202 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 159163 | 2021493872 | K240884 | Glide (91000-GL-X) | GXY | 2024-04-15 |
| 159163 | 1348670724 | K182112 | Sense System with IBT Electrodes | GXY | 2018-10-05 |
| 159163 | 1527567266 | K173571 | Element System with IBT Electrodes | GXY | 2018-03-21 |
| 159163 | 1211570818 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| GXY | 3 | 2024-04-15 |
PMN#
Sense System With IBT Electrodes
Infinite Biomedical Technologies, LLC
Element System With IBT Electrodes
Infinite Biomedical Technologies, LLC
VIGILANT EEG MONITOR MODEL VIGILANT 2.0
INFINITE BIOMEDICAL TECHNOLOGIES, LLC
VIGILANT EEG MONITOR, VIGILANT 2.0
INFINITE BIOMEDICAL TECHNOLOGIES, LLC
MODEL I-2000 MONITOR
INFINITE BIOMEDICAL TECHNOLOGIES
GUDID#
Glide - Glide Fabrication kit with 4 dummies
2025-03-20
Glide - Glide Fabrication kit with 8 dummies
2025-03-20
Glide - 91000-GL-B
2024-04-30
Glide - Glide - For Ottobock Axon-Bus System(AxonArm Ergo, Michelangelo hand, AxonHook, and/or AxonRotation) configurations
2024-04-30
Glide - For Hosmer E2 elbow configurations
2024-04-30
Glide - For Motion Control U3+ elbow configurations
2024-04-30
Glide - For Steeper Espire Pro/Hybrid elbow configurations
2024-04-30
Glide - For the Steeper Espire Classic Plus elbow configurations
2024-04-30
Glide - Glide - For the ErgoArm with non-grip control configurations
2024-04-30
Glide - For the ErgoArm with direct grip control configurations
2024-04-30
Glide - For the Motion Control ProWrist or Ottobock Myorotronic or Hand only configurations
2024-04-30
Glide - For the DynamicArm configurations
2024-04-30
Glide - For the DynamicArm Plus configurations
2024-04-30
Glide - For the Motion Arm Hybrid Cable Lock configurations
2024-04-30
Glide - For the Motion Arm Hybrid Electric Lock configurations
2024-04-30
Glide - Core2 Fabrication Kit
2024-04-30
Glide - Dome Fabrication Kit - ST
2024-04-30
Glide - Core2 Controller - GL
2024-04-30
Glide - IBT Remote Dome Electrode - Black
2024-04-30
Glide - IBT Remote Dome Electrode - Red
2024-04-30
Glide - IBT Remote Dome Electrode - Blue
2024-04-30
Glide - IBT Remote Dome Electrode - Green
2024-04-30
Glide - IBT Remote Dome Electrode - Orange
2024-04-30
Glide - IBT Remote Dome Electrode - Purple
2024-04-30
Glide - IBT Remote Dome Electrode - Brown
2024-04-30
Glide - IBT Remote Dome Electrode - Gray
2024-04-30
Glide - For Motion Control Standard Wrist or Ottobock 10S17 Wrist Configuration
2024-04-24
Sense System with IBT Electrodes - Surface electrodes for Electromyography with Pattern Recognition controller - Hand Only (TASKA with grips)
2021-03-02
Sense System with IBT Electrodes - Surface electrodes for Electromyography with Pattern Recognition controller - Hand and wrist (TASKA with grips)
2021-03-02
Element System with IBT Electrodes - Surface electrodes for Electromyography with controller - Coaxial Plug or Ottobock Wrist
2021-02-23
Element System with IBT Electrodes - Surface electrodes for Electromyography with controller - Dynamic Arm
2021-02-23
Sense System with IBT Electrodes - Surface electrodes for Electromyography with Pattern Recognition controller - Hand Only (with grips)
2021-02-23
Sense System with IBT Electrodes - Surface electrodes for Electromyography with Pattern Recognition controller - Hand Only (without grips)
2021-02-23
Sense System with IBT Electrodes - Surface electrodes for Electromyography with Pattern Recognition controller - Hand and Wrist (with grips)
2021-02-23
Sense System with IBT Electrodes - Surface electrodes for Electromyography with Pattern Recognition controller - Hand and Wrist (without grips)
2021-02-23
Sense System with IBT Electrodes - Surface electrodes for Electromyography with Pattern Recognition controller - Passthrough Elbow (Hand with grips with Wrist)
2021-02-23
Sense System with IBT Electrodes - Surface electrodes for Electromyography with Pattern Recognition controller - Passthrough Elbow (Hand with grips without Wrist)
2021-02-23
Sense System with IBT Electrodes - Surface electrodes for Electromyography with Pattern Recognition controller - Passthrough Elbow (Hand without grips with Wrist)
2021-02-23
Sense System with IBT Electrodes - Surface electrodes for Electromyography with Pattern Recognition controller - Passthrough Elbow (Hand without grips without Wrist)
2021-02-23
Sense System with IBT Electrodes - Surface electrodes for Electromyography with Pattern Recognition controller - E2 Elbow (Hand with grips with Wrist)
2021-02-23