ZIMMER MEDIZINSYSTEME GMBH

Reg #: 8010720 · FEI: 7759 · Expires 2026

View on FDA

Products

Proprietary Names

Establishment Types

Classifications

Registration Details

Registration Name: ZIMMER MEDIZINSYSTEME GMBH
Registration Number: 8010720
FEI Number: 7759
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: JUNKERSSTRASSE 9
City: NEU-ULM Bavaria
Country: DE

Regulatory Submissions

510(k) Number: K161862

Owner / Operator

Firm Name: ZIMMER MEDIZINSYSTEME GMBH
Operator Number: 8010720
Address: 3 Goodyear Suite B
City: Irvine
State: CA
Postal Code: 92618
Country: US
Correspondent: Valeria Perez Zimmer

US Agent

Business Name: ZIMMER MEDIZINSYSTEMS CORP.
Contact Name: Valeria Perez Zimmer
Address: 3 Goodyear Ste B
City: IRVINE
State: CA
ZIP: 92618
Country: US
Email: [email protected]
Phone: 800 3273576

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat	IMJ	Class 2	Physical Medicine	No	2016-11-30
Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat	IMI	Class 2	Physical Medicine	No	2025-02-18
Massager, Vacuum, Radio Frequency Induced Heat	PBX	Class 2	General, Plastic Surgery	No	2023-05-31
Powered Laser Surgical Instrument	GEX	Class 2	General, Plastic Surgery	No	2016-12-20
Equipment, Traction, Powered	ITH	Class 2	Physical Medicine	No	2023-05-31
Electrode, Cutaneous	GXY	Class 2	Neurology	No	2016-11-30
Stimulator, Muscle, Powered, For Muscle Conditioning	NGX	Class 2	Physical Medicine	No	2024-07-26
Massager, Therapeutic, Electric	ISA	Class 1	Physical Medicine	No	1984-12-13
Lamp, Infrared, Therapeutic Heating	ILY	Class 2	Physical Medicine	No	2020-08-07
Stimulator, Muscle, Powered	IPF	Class 2	Physical Medicine	No	2026-02-03
Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat	IMG	Class 2	Physical Medicine	No	2012-08-09
Stimulator, Nerve, Transcutaneous, For Pain Relief	GZJ	Class 2	Neurology	No	2012-08-09
Interferential Current Therapy	LIH	Class 2	Neurology	No	2012-08-09
Pack, Hot Or Cold, Reusable	IME	Class 1	Physical Medicine	No	1997-06-10
Stimulator, Electrical, Non-Implantable, For Incontinence	KPI	Class 2	Gastroenterology, Urology	No	2023-10-12

Proprietary Names

ThermoPro ThermoTK Tecarpuls II Cynosure SmartCool Family Cold Air Device: SmartCool, SmartCool 6, Cryo C ZShape clTrac Zimmer Trodes CryoOne CRYO 6 Z STIM CoolTone ZWave Pro enPuls Pro ZWaveQ enPuls2 enShock Endopuls FSWT EndoPuls 811 ZWave US-Wave OptonPro 25W Endolaser HP Cryo 7 Opton Pro Cryo Mini emFieldPro emField Soleo Sono, Soleo Stim,, Soleo SonoStim CRYO 6PT CRYO 5 MFG-05

Establishment Types

Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device for Another Party (Contract Manufacturer)