Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016592682

FEI Number

3016592682

Entity Name

BIOINTELLISENSE INC.

City/State/Country

Redwood City, CA, US

Establishment Address

805 Veterans Blvd, UNIT 105, Redwood City, CA 94063, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BioIntelliSense Inc. (Owner Number: 10062701)

Owner / Operator Contact Address

805 Veterans Blvd, UNIT 105, Redwood City, CA 94063, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BioSticker BioSticker wearable sensor BioSticker on-body sensor BioSticker wearable device BioSticker remote patient monitoring device BioButton BioButton wearable device BioButton remote patient monitoring device BioButton wearable sensor BioButton Adhesives v2 (2x5pcs and 50x5pcs, HT, ADD, ADH-AC1-BBR) BioButton Adhesives v1 (2x5pcs and 50x5pcs, OMI, ADB, ACCS-1-ST06-1-4F) BioButton Adhesive V2, Cold Seal (ADH-CS) BioButton Charging Station BioButton System (Multi-patient Use or MPU) BioButton MPU BioButton v3 BioButton Rechargeable (BBR) BioButton Rechargeable BioIntelliSense Body Orientation Tracker (BOT)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2020-03-03
NDC	Calculator, Drug Dose	Anesthesiology	Class 2	868.1890	2020-03-03
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2022-12-14
NDC	Calculator, Drug Dose	Anesthesiology	Class 2	868.1890	2022-12-14
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2022-02-09
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2024-09-30
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2024-09-30
KMI	Monitor, Bed Patient	General Hospital	Class 1	880.2400	2023-12-18

Official Correspondent

Yusi Liu

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BioIntelliSense Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3017986070	BIOINTELLISENSE INC.	Golden, CO, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K131913	Philips Medizin Systeme Boeblingen GmbH	INTELLIVUE CL SPO2 POD AND CL NBP POD, PHILIPS INTELLIVUE PATIENT MONITORS MP5, MP5T, MP5SC	2013-11-26
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

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3012302888	QUIPMENT INC.	Kennesaw, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016592682. Last updated year: 2026. Please use registration number 3016592682 when referencing this establishment in official correspondence.