JFC · System, Pressure Measurement, Intermittent
Physical Medicine · 21 CFR 890.1600 · Class 1
Overview
| Product Code | JFC |
|---|---|
| Device Name | System, Pressure Measurement, Intermittent |
| Regulation | 21 CFR 890.1600 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
Identification
An intermittent pressure measurement system is an evaluative device intended for medical purposes, such as to measure the actual pressure between the body surface and the supporting media.
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 (11 of 11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K924705 | FORCE SENSING ARRAY | Force Sensing Systems | May 12, 1993 | SESE |
| K925258 | DYNAMIC PRESSURE MONITOR 2000M AND 2000C | Pin Dot Products, Inc. | Mar 9, 1993 | SESE |
| K925052 | QA PRESSURE MEASUREMENT SYSTEM | Gabel Medical Instruments, Ltd. | Mar 9, 1993 | SESE |
| K915278 | CDG GAIT ANALYSES SYSTEM | Wrm Computers | Apr 7, 1992 | SESE |
| K914776 | OXFORD PRESSURE MONITOR/TALLEY PRESSURE MONITOR | Talley Group, Ltd. | Dec 19, 1991 | SESE |
| K913510 | MECHANICAL SHAPE SENSOR | Pin Dot Products, Inc. | Sep 23, 1991 | SESE |
| K881284 | COMPUTERIZED ORTHOPAEDIC PEDOTOPOGRAPHY MACHINE | Nathaniel Gould Diagnostics, Inc. | Jul 21, 1988 | SESE |
| K882139 | 2P-QDA FOOT PRESSURE SYSTEMS REAL TIME | Human Performance Technologies, Inc. | Jun 22, 1988 | SESE |
| K861260 | PEDABAROGRAPH | Biokinetics, Inc. | May 2, 1986 | SESE |
| K831800 | TEXAS INTERFACE PRESSURE EVALUATOR-TIPE | Tee-Kay Applied Technology | Aug 16, 1983 | SESE |
| K823681 | MODEL ICPM & ACCESSORIES | Electromedics, Inc. | Feb 23, 1983 | SESE |
Top Applicants
- Pin Dot Products, Inc. — 2 clearances
- Biokinetics, Inc. — 1 clearance
- Electromedics, Inc. — 1 clearance
- Force Sensing Systems — 1 clearance
- Gabel Medical Instruments, Ltd. — 1 clearance
