Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3036722175

FEI Number

3036722175

Entity Name

PRANAQ PTE. LTD.

City/State/Country

Singapore Central Singapore, SG

Establishment Address

9 Straits View, #05-07, Marina One West Tower, Singapore Central Singapore 018937, SG

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

PranaQ Pte. Ltd. (Owner Number: 10092786)

Owner / Operator Contact Address

9 Straits View,, #05-07, Marina One West Tower,, Singapore, SG-01 018937, SG

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K243268

PMA Number

N/A

All Registered Proprietary Names

TipTraQ TipTraQ (TTQ001) Strap (TipTraQ's accessory) Charging Case (TipTraQ's accessory) TipTraQ Companion app (TipTraQ's software) TipTraQ Kit (TipTraQ's hardware component kit) TipTraQ Expert Panel (TipTraQ's software) TipTraQ Sensor (TipTraQ's main wearable device)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2025-02-18

Official Correspondent

Tzu-Hsuan Kuo

US Agent Details

Jerry Chen Business: PranaQ, Co. Email: jerry.chen@pranaq.com Phone: (646) 3374389

Related Public Records

Same Entity

PranaQ Pte. 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
K082968	Apneicare, LLC	APNEICARE CONNECTION CENTER/INTERNET ANALYSIS	2009-01-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2022	NOX MEDICAL Keldnaholt Reykjavik Iceland	2	Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.

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3026753386	ONERA B.V.	Eindhoven Noord-Brabant, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3036722175. Last updated year: 2026. Please use registration number 3036722175 when referencing this establishment in official correspondence.