PDC RESTORER, LLC

FDA Device Registration & Listing · Indianapolis, IN, US · Registration 3010984291

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
3010984291
FEI Number
3010984291
Entity Name
PDC RESTORER, LLC
City/State/Country
Indianapolis, IN, US
Establishment Address
6330 East 75th Street, Suite 128, Indianapolis, IN 46250, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Advanced Healing Initiative LLC (Owner Number: 10089872)
Owner / Operator Contact Address
8131 Castleton Road, Indianapolis, IN 46250, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K080304
PMA Number
N/A

All Registered Proprietary Names

PDC Restorer

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Neurology Class 2 882.5890 2024-01-17

Official Correspondent

David Cole

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Advanced Healing Initiative 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
K122948 Gemore Technology Co, Ltd. GEM-STIM COMBO STIMULATOR 2012-12-21
K033455 Biomedical Life Systems, Inc. ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5 2004-01-15
K810593 Medical Devices, Inc. NEUROPAC ULTRA I 1981-03-13

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010984291. Last updated year: 2026. Please use registration number 3010984291 when referencing this establishment in official correspondence.
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