Clinic 2000 Model Multi-Frecodyn Device
by Dimeco 510(k)
Active
510(k) K820784
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK820784 | Date22 Apr 1982 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- IPF
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5850
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 23 Sep 2026
The Clinic 2000 Model Multi-Frecodyn Device is a physical medicine device manufactured by Dimeco. It is designed for use in clinical settings to provide therapeutic treatment.
The device is supplied by Dimeco and is authorized under FDA 510K clearance with product code IPF. It is intended for use in physical medicine applications and is regulated as a substantially equivalent device.
Questions
AI-generated answers, 23 Sep 2026
What is the Clinic 2000 Model Multi-Frecodyn Device used for?
The Clinic 2000 Model Multi-Frecodyn Device is a physical medicine device designed for therapeutic treatment in clinical settings. It is manufactured by Dimeco and intended specifically for physical medicine applications.
How is the Clinic 2000 Model Multi-Frecodyn Device supplied?
The device is supplied directly by Dimeco, the manufacturer. It is authorized under FDA 510K clearance with product code IPF and is regulated as a substantially equivalent device in physical medicine applications.
What is the regulatory status of the Clinic 2000 Model Multi-Frecodyn Device?
The device has FDA 510K clearance with product code IPF and is classified as substantially equivalent. It was reviewed by the Physical Medicine advisory committee and received traditional clearance on April 22, 1982.
Is the Clinic 2000 Model Multi-Frecodyn Device reusable or single-use?
The device data does not specify whether the Clinic 2000 Model Multi-Frecodyn Device is reusable or single-use. For information regarding device reuse or disposal, please consult the manufacturer's instructions or contact Dimeco directly.