Product code IKE
- Device name
- Transducer, Miniature Pressure
- Medical specialty
- Physical Medicine
- Device class
- 1
- Regulation number
- 890.1615
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K060125 | SONIC PALPOMETER | Palpometer Systems, Inc. | 2006-03-16 |
| K954670 | PRESSORE MONITOR | Cleveland Medical Devices, Inc. | 1995-10-30 |
| K915369 | THE EQUALIZER | Advanced Rehabilitative Technology, Inc. | 1993-03-22 |
| K915326 | PORTABLE LIMB LOAD MONITOR (BMLLM-100) | Bar Med Pty , Ltd. | 1992-10-20 |
| K920091 | IOWA ORAL PERFORMANCE ISNTRUMENT | Breakthrough, Inc. | 1992-05-20 |
| K915897 | FPL | Wrm Computers | 1992-04-07 |
| K914780 | TALLEY SD.500 SKIN PRESSURE EVALUATOR | Talley Group, Ltd. | 1991-12-19 |
| K902967 | MICRO-EMED-SYSTEM | Novel Electronics, Inc. | 1990-09-17 |
| K880912 | DYNATRON 2000 | Dynatronics Corp. | 1988-03-15 |
| K875103 | BIO-FEEDBACK LIMB MONITOR TYPE CODE BL-34-1 | Shield Computers , Ltd. | 1988-01-20 |
| K871690 | EMED-F-SYSTEM | Novel GmbH | 1987-05-15 |
| K864499 | PODOSCOPE | Broadwest Corp. | 1987-02-04 |
| K864569 | PODODIGITAL | Broadwest Corp. | 1987-02-04 |
| K844202 | MOSS LIMB LOAD MONITOR LM101-1 | Moss Rehabilation Hospital | 1984-11-27 |
| K843634 | ASC 4080 SYSTEM | Atlantis Scientific Corp. | 1984-11-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00866736000314 | Reflux Band Manometer | The Reflux Company | 2026-10-08 |
| 00866736000383 | Reflux Band Pressure Sensor | The Reflux Company | 2026-10-08 |
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| 10810091040284 | IOPI® | Iopi Medical LLC | 2025-03-21 |
| 10810091040253 | IOPI® | Iopi Medical LLC | 2025-03-21 |
| 10810091040277 | IOPI® | Iopi Medical LLC | 2025-03-21 |
| 10810091040291 | IOPI® | Iopi Medical LLC | 2025-03-21 |
| 00816271020797 | myoRESEARCH | Noraxon U.S.A., Inc. | 2023-06-07 |
| 10810091040031 | IOPI® | Iopi Medical LLC | 2022-10-20 |
| 10810091040048 | IOPI® | Iopi Medical LLC | 2022-10-20 |
| 10810091040055 | IOPI® | Iopi Medical LLC | 2022-10-20 |
| 10810091040000 | IOPI® | Iopi Medical LLC | 2022-10-20 |
| 10810091040024 | IOPI® | Iopi Medical LLC | 2022-10-20 |
| 10810091040062 | IOPI® | Iopi Medical LLC | 2022-10-20 |