MTS Medical AG

FDA Device Registration & Listing · KONSTANZ Baden-Wurttemberg, DE · Registration 3005462245

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
3005462245
FEI Number
3005462245
Entity Name
MTS Medical AG
City/State/Country
KONSTANZ Baden-Wurttemberg, DE
Establishment Address
ROBERT-BOSCH-STRASSE 18, ROBERT-BOSCH-STRASSE 9 (Production Facility), ROBERT-BOSCH-STRASSE 11 (Purchasing, Incoming goods, Storage), KONSTANZ Baden-Wurttemberg 78467, DE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
MTS Medical AG (Owner Number: 9088139)
Owner / Operator Contact Address
ROBERT-BOSCH-STRASSE 18, ROBERT-BOSCH-STRASSE 9, KONSTANZ, DE-BW 78467, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K182682
PMA Number
N/A

All Registered Proprietary Names

OrthoGold100, model OW100-US DermaGold100, model OW100-US Softwave Gold Li DermaGold100, model OW100S-US OrthoGold100, model OW100-US

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 2021-06-08
PZL Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers General, Plastic Surgery Class 2 878.4685 2020-02-06
PZL Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers General, Plastic Surgery Class 2 878.4685 2024-08-28
PZL Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers General, Plastic Surgery Class 2 878.4685 2023-09-06
ISA Massager, Therapeutic, Electric Physical Medicine Class 1 890.5660 2019-01-08

Official Correspondent

Ralph Reitmajer

US Agent Details

Tom Rhodes Business: SoftWave Tissue Regeneration Technologies LLC. Email: edrew@softwavetrt.com Phone: (888) 8626162

Related Public Records

Same Entity

MTS Medical AG
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005462245. Last updated year: 2026. Please use registration number 3005462245 when referencing this establishment in official correspondence.
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