Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9615108

FEI Number

3003778509

Entity Name

NOVAFON Elektromedizinische Geraete GMBH

City/State/Country

Weinstadt Baden-Wurttemberg, DE

Establishment Address

Daimlerstrasse 13, Weinstadt Baden-Wurttemberg 71384, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

NOVAFON Elektromedizinische Geraete GMBH (Owner Number: 9039396)

Owner / Operator Contact Address

Daimlerstrasse 13, --, Weinstadt, DE-BW 71384, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

NOVAFON pro Shani Darden Facial Sculpting Wand DAS NOVAFON DAS NOVAFON power NOVAFON max+ Magnetic Attachment DAS NOVAFON power 2 DAS NOVAFON DAS NOVAFON power Magnetic Attachment Shani Darden Facial Sculpting Wand DAS NOVAFON power 2 NOVAFON max+ NOVAFON pro

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	1999-10-25
IRO	Vibrator, Therapeutic	Physical Medicine	Class 1	890.5975	2018-10-22

Official Correspondent

No official correspondent registered.

US Agent Details

Christie Teller Business: Tools for Wellness Email: christie@toolsforwellness.com Phone: (800) 4569887

Related Public Records

Same Entity

NOVAFON Elektromedizinische Geraete GMBH

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
K821133	Durham Electric Co.	ELECTRICAL VIBRATING DEVICE	1982-07-09

Similar Registrations

Registration Number	Establishment Name	Location
3016460723	ZHEJIANG AOLIN INDUSTRY & TRADE CO., LTD.	Lishui Zhejiang, CN
3032903908	TECHDERM LLC	Palm Beach Gardens, FL, US
3030407739	CL MEDIX INC	Chantilly, VA, US
3009079475	Aerotel Ltd.	Holon Central, IL
3025350087	LENYO WORLD LTD	Budapest, HU

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615108. Last updated year: 2026. Please use registration number 9615108 when referencing this establishment in official correspondence.