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 890.1615](/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/890.1615) → IKE — Transducer, Miniature Pressure

# IKE · Transducer, Miniature Pressure

_Physical Medicine · 21 CFR 890.1615 · Class 1_

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

## Overview

- **Product Code:** IKE
- **Device Name:** Transducer, Miniature Pressure
- **Regulation:** [21 CFR 890.1615](/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/890.1615)
- **Device Class:** 1
- **Review Panel:** [Physical Medicine](/submissions/PM)

## 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](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKE/K060125.md) | SONIC PALPOMETER | Palpometer Systems, Inc. | Mar 16, 2006 | SESE |
| [K954670](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKE/K954670.md) | PRESSORE MONITOR | Cleveland Medical Devices, Inc. | Oct 30, 1995 | SESE |
| [K915369](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKE/K915369.md) | THE EQUALIZER | Advanced Rehabilitative Technology, Inc. | Mar 22, 1993 | SESE |
| [K915326](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKE/K915326.md) | PORTABLE LIMB LOAD MONITOR (BMLLM-100) | Bar Med Pty , Ltd. | Oct 20, 1992 | SESE |
| [K920091](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKE/K920091.md) | IOWA ORAL PERFORMANCE ISNTRUMENT | Breakthrough, Inc. | May 20, 1992 | SESE |
| [K915897](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKE/K915897.md) | FPL | Wrm Computers | Apr 7, 1992 | SESE |
| [K914780](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKE/K914780.md) | TALLEY SD.500 SKIN PRESSURE EVALUATOR | Talley Group, Ltd. | Dec 19, 1991 | SESE |
| [K902967](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKE/K902967.md) | MICRO-EMED-SYSTEM | Novel Electronics, Inc. | Sep 17, 1990 | SESE |
| [K880912](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKE/K880912.md) | DYNATRON 2000 | Dynatronics Corp. | Mar 15, 1988 | SESE |
| [K875103](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKE/K875103.md) | BIO-FEEDBACK LIMB MONITOR TYPE CODE BL-34-1 | Shield Computers , Ltd. | Jan 20, 1988 | SESE |
| [K871690](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKE/K871690.md) | EMED-F-SYSTEM | Novel GmbH | May 15, 1987 | SESE |
| [K864569](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKE/K864569.md) | PODODIGITAL | Broadwest Corp. | Feb 4, 1987 | SESE |
| [K864499](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKE/K864499.md) | PODOSCOPE | Broadwest Corp. | Feb 4, 1987 | SESE |
| [K844202](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKE/K844202.md) | MOSS LIMB LOAD MONITOR LM101-1 | Moss Rehabilation Hospital | Nov 27, 1984 | SESE |
| [K843634](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKE/K843634.md) | 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

---

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

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