Identifiers
- 510(k) Number
- K222912 FDA 510(k)
- FDA Product Code
- ITH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5900 FDA 510(k)
- Regulation Number
- 890.5900 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The C1trac is a powered traction device classified as physical medicine equipment. It is designed to provide traction therapy as indicated by its regulation number 890.5900.
This device has received FDA 510(k) clearance under the product code ITH. It is manufactured by Zimmer MedizinSysteme GmbH and is identified by the K-number K222912.
Frequently asked questions
What is the primary function of the c1Trac?
The c1Trac is a powered traction device designed for use in physical medicine. It is classified under regulation number 890.5900 to provide traction therapy to patients.
Has the c1Trac received regulatory clearance?
Yes, the c1Trac has received FDA 510(k) clearance. It is identified by the K-number K222912 and is classified under product code ITH.
Who is the manufacturer of the c1Trac device?
The c1Trac is manufactured by Zimmer MedizinSysteme GmbH, located in Neu-Ulm, Germany.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: c1Trac (K222912) — FDA 510 (k) | Innolitics, clTrac | Zimmer MedizinSysteme GmbH, K222912 FDA 510 (k) - c1Trac | Zimmer Medizinsysteme GmbH, PDF May 16, 2023 Zimmer MedizinSysteme GmbH ℅ Scott Blo
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K222912 | Class II | Active |
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Manufacturer
- Manufacturer
- Zimmer MedizinSysteme GmbH
Sources (1)
- FDA 510(k) K222912 24 fields · synced Sep 25, 2026