WITKO INCORPORATED

FDA Device Registration & Listing · Wolcott, IN, US · Registration 3003255790

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
3003255790
FEI Number
3003255790
Entity Name
WITKO INCORPORATED
City/State/Country
Wolcott, IN, US
Establishment Address
9055 W Wolcott Industrial Pkwy, Wolcott, IN 47995, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Witko Incorporated (Owner Number: 10044870)
Owner / Operator Contact Address
9055 W Wolcott Industrial Pkwy, Wolcott, IN 47995, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Smart Relief ThermaCare

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NYN Stimulator, Electrical, Transcutaneous, For Arthritis Neurology Class 2 882.5890 2013-08-12
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter Neurology Class 2 882.5890 2013-08-12
IMD Pack, Hot Or Cold, Disposable Physical Medicine Class 1 890.5710 2023-01-11

Official Correspondent

Valerie Fredrick

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Witko Incorporated
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

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 3003255790. Last updated year: 2026. Please use registration number 3003255790 when referencing this establishment in official correspondence.
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