IMPLUS FOOTCARE LLC

FDA Device Registration & Listing · Durham, NC, US · Registration 3007145088

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3007145088
FEI Number
3007145088
Entity Name
IMPLUS FOOTCARE LLC
City/State/Country
Durham, NC, US
Establishment Address
2001 T.W. Alexander Drive, Durham, NC 27709, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Implus Footcare LLC (Owner Number: 10026316)
Owner / Operator Contact Address
2001 T.W. Alexander Drive, Durham, NC 27709, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

SPENCO

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IQI Orthosis, Limb Brace Physical Medicine Class 1 890.3475 2018-02-01
ISA Massager, Therapeutic, Electric Physical Medicine Class 1 890.5660 2017-02-27
IOD Components, Exercise Physical Medicine Class 1 890.5350 2017-02-27
PFP Silicone Hydrogel For Scar Management General, Plastic Surgery Class 1 878.4025 2018-03-28
IMD Pack, Hot Or Cold, Disposable Physical Medicine Class 1 890.5710 2025-05-15
IME Pack, Hot Or Cold, Reusable Physical Medicine Class 1 890.5700 2025-05-15
LYG Massager, Therapeutic, Manual Physical Medicine Class 1 890.5660 2020-11-23
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2018-02-22

Official Correspondent

Richard Donnell

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Implus Footcare LLC
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
K880871 John Wagner Associates, Inc. GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER 1988-05-20
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

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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 3007145088. Last updated year: 2026. Please use registration number 3007145088 when referencing this establishment in official correspondence.
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