Search Results
Found 10 results
510(k) Data Aggregation
K Number
K202979Device Name
MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra
Manufacturer
Lode B.V.
Date Cleared
2020-12-21
(82 days)
Product Code
ISD
Regulation Number
890.5360Why did this record match?
Product Code :
ISD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended to be used as a stress test device in a medical environment. The main goal of the devices is to create reproducible stress tests. With cycling ergometers typically workload (watt) is imposed. This product is designed both for manual operation and for control by external software. This device will be used in conjunction with another medical device to obtain other important physiological data, allowing a physician to evaluate a test subjects physical status.
Device Description
MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra
Ask a Question
K Number
K183296Device Name
REAL Immersive System
Manufacturer
Penumbra, Inc.
Date Cleared
2019-03-18
(111 days)
Product Code
ISD
Regulation Number
890.5360Why did this record match?
Product Code :
ISD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The REAL Immersive System is an immersive virtual reality and display system that interactively displays and tracks upper-extremity rehabilitation exercises for adult patients using a combination of virtual environments and full presence tracked avatars for visual feedback. These rehabilitation exercises are intended to be conducted in a seated position in a clinical environment and prescribed and supervised by a medical professional trained in rehabilitation therapy.
Device Description
REAL Immersive System is a digital hardware and software medical device platform using a combination of virtual environments and full presence tracked avatars for visual feedback. It is designed for use in healthcare and focusing on physical and neuro rehabilitation. The use of the device is intended to be in a clinical environment supervised by a medical professional trained in rehabilitation therapy.
REAL Immersive System contains the following components:
- . All-in-One HMD with Software Application
- . HMD Controller
- Wireless Transmitter Module (WTM or Large Sensor) .
- Wireless Sensor Module (WSM or Small Sensor) .
- . Tablet with Software Application
- . Sensor Charger (charging station)
- Router ●
- Router Battery ●
- Sensor Bands .
Ask a Question
K Number
K143512Device Name
ActiSpec Activity Monitor
Manufacturer
SLEEP MODUS, INC.
Date Cleared
2015-08-26
(258 days)
Product Code
ISD
Regulation Number
890.5360Why did this record match?
Product Code :
ISD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ActiSpec® is a small limb worn activity monitor designed for documents associated with applications in physiological monitoring. The device intended use is to analyze limb activity associated with movement during sleep. The unit can also be used to assess activity in any instance where quantifiable analysis of physical motion is desirable.
Device Description
ActiSpec® consists of a pair of toe bands containing firmware within the toe band housing, and an offline data download, scoring, and report generation tool. The ActiSpec® toe band is a small, battery-operated activity monitor worn on the big (great) toe. ActiSpec® typically is packaged as a pair of toe bands, one for each big toe.
ActiSpec® measures, records, and scores movements caused by the contraction of the tibialis anterior muscle responsible for movement of the big toe and dorsiflexion of the ankle and foot. These movements are detected by the accelerometer.
The intention is for the patient to wear the toe bands only while sleeping for five (5) consecutive nights. After the fifth night, the patient returns the toe bands to Sleep Modus and a report is generated for the care provider.
The generated report contains statistical information regarding the movements of the patient each night including a graph showing those movements. The report is in the form of a PDF document emailed to the care provider.
ActiSpec® has a 2-year shelf life in addition to a 120-hour active data collection period. Device activation occurs upon removal of the toe bands from the light-proof packaging.
Ask a Question
K Number
K112121Device Name
ERGOSELECT/GE
Manufacturer
ERGOLINE GMBH
Date Cleared
2012-10-31
(464 days)
Product Code
ISD
Regulation Number
890.5360Why did this record match?
Product Code :
ISD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Physiotherapy in redevelopment of muscles for restoration of motion to joints or for use as an adjunct treatment for obesity.
Device Description
The Ergoselect is the result of long-standing experience and its consequent implementation. The system is convincing thru the optimal, and therefore, cost-effective configuration of the ergometer according to in medical ergometer specific requirements. Modern computer control allows Stand-alone operation of the ergometer as well as comfortable control via external devices (PC system). Ergoline Ergoselect / GE measures data concerning patients procedures and in conjunction with ergometer bicycles procedures. Ergoselect / GE ergometer includes following models (P/K versions): Ergoselect 50, Ergoselect 100 / 200, Ergoselect 600, Ergoselect 1000, Ergoselect 1200, Optibike 50 med, Optibike med.
Ask a Question
K Number
K080545Device Name
ACTITRAINER
Manufacturer
ACTIGRAPH, LLC
Date Cleared
2008-07-24
(148 days)
Product Code
ISD
Regulation Number
890.5360Why did this record match?
Product Code :
ISD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ActiTrainer is a small worn activity monitor designed for documenting physical movement associated with applications in physiological monitoring. The device is intended to monitor the activity associated with movement during sleep. The ActiTrainer can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.
Device Description
The ActiTrainer is housed in a polycarbonate plastic housing. It is 8.5 cm long by 3.4 cm wide by 1.6 cm thick and it weights 51 grams. It also has an optional Polar heart strap. Data is downloaded into a PC via a USB plug and the data is displayed with ActiGraph LLC's ActiLife software.
Ask a Question
K Number
K053078Device Name
ERGOSELECT 100 K/P, ERGOSELECT 200 K/P
Manufacturer
ERGOLINE GMBH
Date Cleared
2006-04-27
(176 days)
Product Code
ISD
Regulation Number
890.5360Why did this record match?
Product Code :
ISD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Physiotherapy in redevelopment of muscles for restoration of motion to joints or for use as an adjunct treatment for obesity.
Device Description
The Ergoselect 100 K/P; Ergoselect 200 K/P ergometer has been designed to meet the medical and ergonomic requirements for an efficient and relevant stress test of the cardiovascular system. Modern computer control allows Stand-alone operation of the ergometer as well as comfortable control via external devices (PC system). Ergoline Ergoselect 100 K/P; Ergoselect 200 K/P ergometer measures data concerning patients procedures and in conjunction with ergometer bicycles procedures.
The ergometry system Ergoline Ergoselect 100 K/P; Ergoselect 200 K/P consists out of the following components: Basic unit: Ergoselect 100: Ergoselect 200 Control panel type P / K Control unit: Ergoline Ergoselect 100 K/P; Ergoselect 200 K/P ergometer measures data concerning patients procedures and in conjunction with ergometer bicycles procedures.
Ask a Question
K Number
K990866Device Name
QUINTON MEDTRACK CR PLUS TREADMILL
Manufacturer
QUINTON, INC.
Date Cleared
1999-04-29
(44 days)
Product Code
ISD
Regulation Number
890.5360Why did this record match?
Product Code :
ISD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Quinton MedTrack CR Plus Treadmill is intended to be used as a rehabilitation device for cardiovascular conditioning. The intended population are ambulatory patients undergoing exercise rehabilitation.
Device Description
Not Found
Ask a Question
K Number
K990813Device Name
REHCOR
Manufacturer
ELECTROMED CORP.
Date Cleared
1999-04-12
(32 days)
Product Code
ISD, MEA
Regulation Number
890.5360Why did this record match?
Product Code :
ISD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Useful for physiotherapy in redevelopment of muscles or for restoration of motion to joints or for use as an adjunct treatment for obesity. The bicycle would be Class I exempt when sold without measuring capability but is available with ECG and/or blood pressure measuring options thus making it Class II, not exempt. The unit's workload can be controlled by an RS-232 input for connection to ECG stress test systems (supplied by other manufacturers)
Device Description
Not Found
Ask a Question
K Number
K962855Device Name
ULE-2, MULE-2, HAND ACCESSORY KIT
Manufacturer
PENNY AND GILES BIOMETRICS LTD.
Date Cleared
1996-12-11
(142 days)
Product Code
ISD
Regulation Number
890.5360Why did this record match?
Product Code :
ISD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Not Found
Device Description
Not Found
Ask a Question
K Number
K952163Device Name
DAVID BACK CLINIC SYSTEM
Manufacturer
KINETIC RESOURCES, INC.
Date Cleared
1996-08-12
(462 days)
Product Code
ISD
Regulation Number
890.5360Why did this record match?
Product Code :
ISD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
Page 1 of 1