RESTORATIVE THERAPIES INC.

FDA Device Registration & Listing · Nottingham, MD, US · Registration 3004733458

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
3004733458
FEI Number
3004733458
Entity Name
RESTORATIVE THERAPIES INC.
City/State/Country
Nottingham, MD, US
Establishment Address
8098 Sandpiper Circle, Suite M, Nottingham, MD 21236, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
RESTORATIVE THERAPIES INC. (Owner Number: 9066635)
Owner / Operator Contact Address
8098 Sandpiper Circle, Suite M, Nottingham, MD 21236, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K160614
PMA Number
N/A

All Registered Proprietary Names

RT200 FES elliptical ergometer Xcite FES system

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GZI Stimulator, Neuromuscular, External Functional Neurology Class 2 882.5810 2013-10-23
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2016-12-19
GZI Stimulator, Neuromuscular, External Functional Neurology Class 2 882.5810 2016-12-19

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

RESTORATIVE THERAPIES INC.
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
K030403 Cefar Medical AB CEFAR REHAB 2 AND REHAB 2 PRO 2003-07-17
K231440 Shenzhen Roundwhale Technology Co. , Ltd. Combo Electrotherapy Device 2023-11-03
K820884 Nitron Electronics ELECTRICAL MUSCLE STIMULATOR 1982-04-29
K201958 Therasigma, LLC ETD Family of Electrotherapy Devices 2020-08-04
K964028 Mettler Electronics Corp. SYS STIM 226 1997-02-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004733458. Last updated year: 2026. Please use registration number 3004733458 when referencing this establishment in official correspondence.
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