Healy GMBH

FDA Device Registration & Listing · Kraenzlin Brandenburg, DE · Registration 3016508547

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
3016508547
FEI Number
3016508547
Entity Name
Healy GMBH
City/State/Country
Kraenzlin Brandenburg, DE
Establishment Address
Schloss Kraenzlin, Darritzer Strasse 6, Kraenzlin Brandenburg 16818, DE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
TimeWaver Production GmbH (Owner Number: 10040063)
Owner / Operator Contact Address
Schloss Kraenzlin, Darritzer Strasse 6, Kraenzlin, DE-BB 16818, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K212832
PMA Number
N/A

All Registered Proprietary Names

HEALY TimeWaver Frequency

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter Neurology Class 2 882.5890 2020-01-17
NYN Stimulator, Electrical, Transcutaneous, For Arthritis Neurology Class 2 882.5890 2020-01-17
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2021-12-15
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Neurology Class 2 882.5890 2021-12-15

Official Correspondent

Babak Jafarian

US Agent Details

Douglas Herrington Business: Herrington Consulting LLC Email: dgls_herrington@yahoo.com Phone: (248) 3695564

Related Public Records

Same Entity

TimeWaver Production GmbH
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3009411292 TimeWaver Production GMBH Kraenzlin Brandenburg, DE

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 3016508547. Last updated year: 2026. Please use registration number 3016508547 when referencing this establishment in official correspondence.
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