Browse hierarchy: [Physical Medicine (PM)](/submissions/PM) → [Subpart B — Physical Medicine Diagnostic Devices](/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices) → [21 CFR 890.1600](/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/890.1600) → JFC — System, Pressure Measurement, Intermittent

# JFC · System, Pressure Measurement, Intermittent

_Physical Medicine · 21 CFR 890.1600 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/JFC

## Overview

- **Product Code:** JFC
- **Device Name:** System, Pressure Measurement, Intermittent
- **Regulation:** [21 CFR 890.1600](/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/890.1600)
- **Device Class:** 1
- **Review Panel:** [Physical Medicine](/submissions/PM)

## 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](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/JFC/K924705.md) | FORCE SENSING ARRAY | Force Sensing Systems | May 12, 1993 | SESE |
| [K925258](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/JFC/K925258.md) | DYNAMIC PRESSURE MONITOR 2000M AND 2000C | Pin Dot Products, Inc. | Mar 9, 1993 | SESE |
| [K925052](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/JFC/K925052.md) | QA PRESSURE MEASUREMENT SYSTEM | Gabel Medical Instruments, Ltd. | Mar 9, 1993 | SESE |
| [K915278](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/JFC/K915278.md) | CDG GAIT ANALYSES SYSTEM | Wrm Computers | Apr 7, 1992 | SESE |
| [K914776](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/JFC/K914776.md) | OXFORD PRESSURE MONITOR/TALLEY PRESSURE MONITOR | Talley Group, Ltd. | Dec 19, 1991 | SESE |
| [K913510](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/JFC/K913510.md) | MECHANICAL SHAPE SENSOR | Pin Dot Products, Inc. | Sep 23, 1991 | SESE |
| [K881284](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/JFC/K881284.md) | COMPUTERIZED ORTHOPAEDIC PEDOTOPOGRAPHY MACHINE | Nathaniel Gould Diagnostics, Inc. | Jul 21, 1988 | SESE |
| [K882139](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/JFC/K882139.md) | 2P-QDA FOOT PRESSURE SYSTEMS REAL TIME | Human Performance Technologies, Inc. | Jun 22, 1988 | SESE |
| [K861260](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/JFC/K861260.md) | PEDABAROGRAPH | Biokinetics, Inc. | May 2, 1986 | SESE |
| [K831800](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/JFC/K831800.md) | TEXAS INTERFACE PRESSURE EVALUATOR-TIPE | Tee-Kay Applied Technology | Aug 16, 1983 | SESE |
| [K823681](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/JFC/K823681.md) | 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

---

**Source:** [https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/JFC](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/JFC)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com