Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3022418645

FEI Number

3022418645

Entity Name

MIO LABS INC.

City/State/Country

Franklin D Roosevelt, NY, US

Establishment Address

KCH, 575 Lexington Ave 14F New York, Franklin D Roosevelt, NY 10022, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Mio Labs Inc. (Owner Number: 10084983)

Owner / Operator Contact Address

4500 Great America Pkwy Suite 1023, Santa Clara, CA 95054, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K191430

PMA Number

N/A

All Registered Proprietary Names

MIO Blood Glucose Monitoring System, model: TeleBGM2282-G TeleRPM Blood Glucose Monitoring System, Meter model: TMB-2282-G, Test strips model: TTS01 Pylo Blood Glucose Monitoring System, Meter model: GL1-LTE, Test strips model:GL1-STP-50

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2023-07-24
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2024-08-26

Official Correspondent

Jialong Fan

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Mio Labs Inc.

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
K150396	Apex BioTechnology Corp.	Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips	2015-10-14
K150833	Andon Health Co, Ltd.	iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System	2015-12-04
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-0004-2009	Lifescan Inc	2	One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.
Z-0042-06	Abbott Laboratories Medisense Products	2	FreeStyle FLASH Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0043-06	Abbott Laboratories Medisense Products	2	Tracker Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0044-06	Abbott Laboratories Medisense Products	2	Xceed Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022418645. Last updated year: 2026. Please use registration number 3022418645 when referencing this establishment in official correspondence.