Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018188848

FEI Number

3018188848

Entity Name

KEY-TECH SCOTLAND LTD

City/State/Country

Dunfermline Fife, GB

Establishment Address

Midfield Road Mitchelston Industrial Eastate, Dunfermline Fife KY13NL, GB

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Key-Tech Scotland LTD (Owner Number: 10080519)

Owner / Operator Contact Address

Midfield Road Mitchelston Industrial Eastate, Dunfermline, GB-FIF KY13NL, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

G2 Wearable Device Lifehub and Lifeglove LX2.3

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2021-12-22
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2021-12-22
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2021-12-22
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2021-12-22
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2021-12-22
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2021-12-22
IKK	System, Isokinetic Testing And Evaluation	Physical Medicine	Class 2	890.1925	2024-12-17
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2024-02-06

Official Correspondent

Simon Revie

US Agent Details

Edwin Lindsay Business: RAF SOLUTIONS USA, INC Email: edwin@rafsolutions.net Phone: (305) 9607262

Related Public Records

Same Entity

Key-Tech Scotland LTD

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K973527	Data Critical Corp.	CARDIO-PAGER SYSTEM	1998-03-31
K182637	Philips Medizin Systeme Boeblingen GmbH	Philips IntelliVue XDS Software	2019-04-26
K903523	Hewlett-Packard Co.	HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE	1990-10-23
K973147	Nellcor Puritan Bennett, Inc.	NPB-295 PULSE OXIMETER	1997-11-14
K231243	Guangdong Genial Technology Co., Ltd.	Finger Clip Pulse Oximeter	2023-10-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M, Part Number CS08653
Z-0029-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M W/PRINTER, Part Number CS08659

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2080783	NIHON KOHDEN AMERICA, INC.	Irvine, CA, US
3013500228	Amphenol Cable and Interconnect Technologies Asia Pacific Ltd.	Tsimshatsui, Kowloon, HK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018188848. Last updated year: 2026. Please use registration number 3018188848 when referencing this establishment in official correspondence.