IKE · Transducer, Miniature Pressure
Physical Medicine · 21 CFR 890.1615 · Class 1
Overview
| Product Code | IKE |
|---|---|
| Device Name | Transducer, Miniature Pressure |
| Regulation | 21 CFR 890.1615 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
Identification
A miniature pressure transducer is a device intended for medical purposes to measure the pressure between a device and soft tissue by converting mechanical inputs to analog electrical signals.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.
Recent Cleared Devices (15 of 15)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K060125 | SONIC PALPOMETER | Palpometer Systems, Inc. | Mar 16, 2006 | SESE |
| K954670 | PRESSORE MONITOR | Cleveland Medical Devices, Inc. | Oct 30, 1995 | SESE |
| K915369 | THE EQUALIZER | Advanced Rehabilitative Technology, Inc. | Mar 22, 1993 | SESE |
| K915326 | PORTABLE LIMB LOAD MONITOR (BMLLM-100) | Bar Med Pty , Ltd. | Oct 20, 1992 | SESE |
| K920091 | IOWA ORAL PERFORMANCE ISNTRUMENT | Breakthrough, Inc. | May 20, 1992 | SESE |
| K915897 | FPL | Wrm Computers | Apr 7, 1992 | SESE |
| K914780 | TALLEY SD.500 SKIN PRESSURE EVALUATOR | Talley Group, Ltd. | Dec 19, 1991 | SESE |
| K902967 | MICRO-EMED-SYSTEM | Novel Electronics, Inc. | Sep 17, 1990 | SESE |
| K880912 | DYNATRON 2000 | Dynatronics Corp. | Mar 15, 1988 | SESE |
| K875103 | BIO-FEEDBACK LIMB MONITOR TYPE CODE BL-34-1 | Shield Computers , Ltd. | Jan 20, 1988 | SESE |
| K871690 | EMED-F-SYSTEM | Novel GmbH | May 15, 1987 | SESE |
| K864569 | PODODIGITAL | Broadwest Corp. | Feb 4, 1987 | SESE |
| K864499 | PODOSCOPE | Broadwest Corp. | Feb 4, 1987 | SESE |
| K844202 | MOSS LIMB LOAD MONITOR LM101-1 | Moss Rehabilation Hospital | Nov 27, 1984 | SESE |
| K843634 | ASC 4080 SYSTEM | Atlantis Scientific Corp. | Nov 8, 1984 | SESE |
Top Applicants
- Broadwest Corp. — 2 clearances
- Advanced Rehabilitative Technology, Inc. — 1 clearance
- Atlantis Scientific Corp. — 1 clearance
- Bar Med Pty , Ltd. — 1 clearance
- Breakthrough, Inc. — 1 clearance
