System, Pressure Measurement, Intermittent
An Intermittent Pressure Measurement System is a physical medicine device used to apply and measure intermittent pneumatic compression to limbs or body segments, supporting the assessment and treatment of conditions such as lymphedema, deep vein thrombosis prevention, and circulatory disorders. It is classified as FDA Class 1 (lowest risk), governed solely by general controls. The product code is JFC, regulated under 21 CFR 890.1600, within the Physical Medicine medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- JFC
- Device Class
- FDA class 1
- Regulation Number
- 890.1600
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K924705 | FORCE SENSING ARRAY | May 12, 1993 | Substantially Equivalent | Force Sensing Systems |
| K925258 | DYNAMIC PRESSURE MONITOR 2000M AND 2000C | Mar 09, 1993 | Substantially Equivalent | Pin Dot Products, Inc. |
| K925052 | QA PRESSURE MEASUREMENT SYSTEM | Mar 09, 1993 | Substantially Equivalent | Gabel Medical Instruments, Ltd. |
| K915278 | CDG GAIT ANALYSES SYSTEM | Apr 07, 1992 | Substantially Equivalent | Wrm Computers |
| K914776 | OXFORD PRESSURE MONITOR/TALLEY PRESSURE MONITOR | Dec 19, 1991 | Substantially Equivalent | Talley Group, Ltd. |
| K913510 | MECHANICAL SHAPE SENSOR | Sep 23, 1991 | Substantially Equivalent | Pin Dot Products, Inc. |
| K881284 | COMPUTERIZED ORTHOPAEDIC PEDOTOPOGRAPHY MACHINE | Jul 21, 1988 | Substantially Equivalent | Nathaniel Gould Diagnostics, Inc. |
| K882139 | 2P-QDA FOOT PRESSURE SYSTEMS REAL TIME | Jun 22, 1988 | Substantially Equivalent | Human Performance Technologies, Inc. |
| K861260 | PEDABAROGRAPH | May 02, 1986 | Substantially Equivalent | Biokinetics, Inc. |
| K831800 | TEXAS INTERFACE PRESSURE EVALUATOR-TIPE | Aug 16, 1983 | Substantially Equivalent | Tee-Kay Applied Technology |
| K823681 | MODEL ICPM & ACCESSORIES | Feb 23, 1983 | Substantially Equivalent | Electromedics, Inc. |
FEI Numbers
This FDA classification entry is associated with 40 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 40 registration numbers. Click on an entry to view related FDA registrations.