Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3022147580

FEI Number

3022147580

Entity Name

IMPILO, Inc.

City/State/Country

Philadelphia, PA, US

Establishment Address

2275 Bridge street, Building 208, unit 110, 300, Philadelphia, PA 19137, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Impilo Health (Owner Number: 10086162)

Owner / Operator Contact Address

2275 Bridge Street, Philadelphia, PA 19137, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K221131

PMA Number

N/A

All Registered Proprietary Names

Bioland Blood Pressure Monitor Instant Hot Pack Bioland Glucose Monitoring System Absorbent Sheet 50 mL 3x4 Impilo Collection Kit - 1140 Guangdong Transtek Medical Electronics Co MICROTAINER BRAND TUBE WITH EDTA TRANSTEK BLOOD PRESSURE MONITOR McKesson Gauze Sponge 2X2 [1ct] Fingertip Bandage iGlucose Glucose Monitoring System Transtek TeleRPM BPM Gen-2 TASSO Blood Lancing Device

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2025-06-30
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2025-07-03
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2025-06-30
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2025-07-03
PQD	Blood Specimen Collection Convenience Kit (Excludes Hiv)	Clinical Chemistry	Class 2	862.1675	2025-07-03
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2022-12-20
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2025-07-03
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2022-10-19
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2025-07-03
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2025-07-03
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2025-06-30
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2025-06-30
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2026-03-20
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2025-07-03

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Impilo Health

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3043025312	IMPILO - PHL Kubach	Philadelphia, PA, US
3031789039	Impilo Phoenix	Phoenix, AZ, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K100940	Andon Health Co, Ltd.	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965	2010-06-29
K251581	Shenzhen Hingmed Medical Instrument Co., Ltd.	Wearable Ambulatory Blood Pressure Monitor (WBP-02A)	2026-02-13
K200521	Health & Life Co., Ltd.	Full Automatic(NIBP) Blood Pressure Monitor	2020-06-12
K152003	Andon Health Co, Ltd.	iHealth BP3L Wireless Blood Pressure Monitor	2015-09-24
K952827	Sein Electronics Co., Ltd.	FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000	1996-11-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0032-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022147580. Last updated year: 2026. Please use registration number 3022147580 when referencing this establishment in official correspondence.