BP-BT Kiosk
LD Technology LLC
LD TECHNOLOGY LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3006146787 | 3006146787 | LD TECHNOLOGY LLC | 1 | N | 2026-01-01 | 990 Biscayne Blvd Ofc O-1403 Miami FL US 33132 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| B322A0011 | SweatC - SweatC device is a medical device for the measurement of galvanic skin response related to the function of the sweat glands. | 305-379-9900 | albert.ldteck@gmail.com |
| B322B0011 | TM-Oxi System - """Oxi-W system is intended for use: To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pulse rate. To analyze the pulse waveform (Photoplethysmography or PTG) provided by the oximeter. It only provides mathematical analysis of the input of the PTG using the first and second derivatives of the PTG values related to the microvascular condition.To analyze the basic rhythms of the NN or RR intervals in heart rate from the PTG, both in the time domain and in the frequency domain (short time 5 minutes). It only provides mathematical analysis of the heart rate variability values related to the autonomic nervous system function.""" | 305-379-9900 | albert.ldteck@gmail.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 101068 | 1261412907 | K200287 | BP-BT Kiosk | DXN | 2020-05-15 |
| 101068 | 1137197821 | K200141 | Oxi-W System | MWI | 2020-04-27 |
| 101068 | 1527536797 | K173696 | TBL-ABI System | JOM | 2017-12-19 |
| 101068 | 1164583549 | K172655 | Automated ankle brachial pressure index measuring device | JOM | 2018-01-11 |
| 101068 | 2040920916 | K160956 | LD-Oxi system | MWI | 2016-07-06 |
| 101068 | 1523005354 | K152216 | SudoC | GZO | 2015-09-24 |
| 101068 | 2038478675 | K143152 | TM-ABI system | JOM | 2015-07-22 |
| 101068 | 1675046959 | K140412 | ANS1 SOFTWARE | DXN | 2014-05-22 |
| 101068 | 1283440539 | K131568 | SUDO PATH | GZO | 2013-06-28 |
| 101068 | 1913087920 | K130056 | PATIENT MONITOR | MWI | 2013-04-11 |
| 101068 | 1564364067 | K120502 | PC-60NW FINGERTIP OXIMETER | DQA | 2012-12-07 |
| 101068 | 1976762526 | K113264 | ELECTRO SENSOR COMPLEX SOFTWARE (ES COMPLEX SOFTWARE) | DXN | 2012-03-02 |
| 101068 | 1756778879 | K103026 | ELECTRO SENSOR -BODY COMPOSITION | MNW | 2011-03-29 |
| 101068 | 1660425659 | K102442 | E.S.O. (ELECTRO SENSOR OXI) | DQA | 2010-09-10 |
| 101068 | 2064368418 | K102166 | ELECTRO INTERSTITIAL SCAN | GZO | 2010-12-10 |
Product Codes Associated With Registrations#
PMN#
Oxi-W System
Ld Technology, LLC
TBL-ABI System
LD Technology LLC
LD-Oxi System
LD TECHNOLOGY LLC
SudoC
LD TECHNOLOGY LLC
TM-ABI System
LD TECHNOLOGY LLC
ANS1 SOFTWARE
LD TECHNOLOGY LLC
SUDO PATH
LD TECHNOLOGY LLC
PATIENT MONITOR
LD TECHNOLOGY LLC
ELECTRO SENSOR COMPLEX SOFTWARE (ES COMPLEX SOFTWARE)
LD TECHNOLOGY LLC
GUDID#
LD-EKG - Replacement blood pressure TBL-ABI: The TBL-ABI is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD). TBL-ABI is intended for the rapid measurement of ankle-brachial pressure index (ABPI), or ankle-brachial index (ABI), and pulse volume recording (PVR) / volume plethysmography in adults. It is suitable for use in wound care assessment, for assessing symptomatic PAD, and as a screening device for PAD. It may also be used on patients with venous or arterial ulcers prior to the application of compression therapy. TBL-ABI can be used on patients with unilateral lower limb amputation.
2024-03-05
SweatC - SweatC device is a medical device for the measurement of galvanic skin response related to the function of the sweat glands.
2019-03-12
TM-Oxi System - """Oxi-W system is intended for use: To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pulse rate. To analyze the pulse waveform (Photoplethysmography or PTG) provided by the oximeter. It only provides mathematical analysis of the input of the PTG using the first and second derivatives of the PTG values related to the microvascular condition.To analyze the basic rhythms of the NN or RR intervals in heart rate from the PTG, both in the time domain and in the frequency domain (short time 5 minutes). It only provides mathematical analysis of the heart rate variability values related to the autonomic nervous system function."""
2019-01-16
BP-BT Lifeprobes Kiosk - """BP-BT Kiosk is designed to measure blood pressure (systolic and diastolic) and pulse rate in adult patients with arm circumference range between 6.7 inches (17.0 cm) to 16.5 inches (42.0 cm). Indication : Prescription use in medical or clinic environment only. Rx only."""
2024-03-05
ES-BC - EC-BC indication for use: Claculation and historical tracking of : Actual resistance, actual reactance, actual impedance, actual phase angle,estimated body fat mass, estimated body water,estimated intra-cellular water, estimated extra-cellular water,estimate basic metabolic rate,estimated daily energy expenditure,actual body fat mass
2024-03-05
ANS1 Software - """ANS1 Software is inetended for use: ANS1 Software is an optional software accessory for use with the following models with datamanagement capabilities: a) TM-Oxi (Oximeter and blood pressure device) and b) SudoPath(Galvanic Skin response) and c) ES-BC (Body Composition Analyzer).When used in combination with TM-Oxi and/or SudoPath, and/or ES-BC devices, the ANS1software uploads the data of the devices, analyzes the data, and then displays the data in ac omputer for enhanced data management.The ANS1 software is intended for use in clinical settings as an aid for health careprofessionals to review, analyze, and evaluate the historical tests results."""
2024-03-05
TBL-ABI - The TBL-ABI is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD). TBL-ABI is intended for the rapid measurement of ankle-brachial pressure index (ABPI), or ankle-brachial index (ABI), and pulse volume recording (PVR) / volume plethysmography in adults. It is suitable for use in wound care assessment, for assessing symptomatic PAD, and as a screening device for PAD. It may also be used on patients with venous or arterial ulcers prior to the application of compression therapy. TBL-ABI can be used on patients with unilateral lower limb amputation.
2019-01-16
LD-Oxy - To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pulse rate. To analyze the pulse waveform (Photoelectrical Plethysmography or PP) provided by the oximeter. It only provides mathematical analyses of the input of the SpO2 measurement. To analyze the basic rhythms of the NN or RR intervals in heart rate, both in the time domain and in the frequency domain (short time 5 minutes). It only provides mathematical analysis of the input of the heart rate variability. The mathematical analysis of Photoelectrical Plethysmography and HRV ARE NOT intended use for diagnosis. The software provides a visual alarm for the values of the heart rate and/or SpO2 percent out of the normal range and for the bad quality signal transmission. The data are stored in PC in the Backup system of the LD-Oxi software. The device is intended use only for adult subjects (> 20 years old) This Oximeter is intended to be used in spot-checking (5 minutes). The device is intended use in licensed practitioner’s office This device is no intended to be used at home, in hospital or out-of-hospital transport The device is not intended use in support life and not for continuously monitoring The system will be use by practitioner.
2019-01-16