FDA product code KHX: Platform, Force-Measuring
KHX is the FDA product code for platform, force-measuring. It is a Class I device, regulated under 21 CFR 890.1575 and reviewed by the Physical Medicine panel. FDA has cleared 15 510(k) submissions under KHX, from 9 different applicants. The average 510(k) review took 108 days (median 90).
Classification
| Field | Value |
|---|---|
| Device name | Platform, Force-Measuring |
| Device class | Class I |
| Regulation | 21 CFR 890.1575 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KHX clearance
Top KHX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Advanced Mechanical Technology, Inc. | 5 | 1988-10-24 |
| Sms Technologies, Ltd. | 2 | 1995-08-11 |
| Neurocom International, Inc. | 2 | 1995-08-04 |
| Biodex Medical Systems, Inc. | 1 | 1995-03-10 |
| Sra Intl., Inc. | 1 | 1992-05-26 |
4 more applicants have KHX clearances. See the full list in Caduvo.
Most recent KHX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K951771 | Sms Technologies, Ltd. | COMMUNITY BALANCE PERFORMANCE MONITOR OR COMMUNITY BPM | 1995-08-11 | 116 |
| K946229 | Neurocom International, Inc. | BALANCE MANAGER | 1995-08-04 | 225 |
| K942694 | Biodex Medical Systems, Inc. | STABILITY SYSTEM (110V) MODEL 945-300; STABILITY SYSTEM (220V) MODEL #945-302 | 1995-03-10 | 276 |
| K930089 | Sms Technologies, Ltd. | SMS BALANCE PERFORMANCE MONITOR | 1993-06-08 | 151 |
| K921340 | Sra Intl., Inc. | FORCE MEASURING PLATFORM | 1992-05-26 | 67 |
Recalls for KHX devices
openFDA lists no recalls for product code KHX.
Frequently asked questions
What is FDA product code KHX?
KHX is the FDA product code for platform, force-measuring. It is a Class I device, regulated under 21 CFR 890.1575 and reviewed by the Physical Medicine panel.
What device class is KHX?
Class I, regulation 21 CFR 890.1575. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KHX?
Across 15 cleared submissions the average was 108 days from receipt to decision (median 90).
Which companies have the most KHX clearances?
Advanced Mechanical Technology, Inc. (5); Sms Technologies, Ltd. (2); Neurocom International, Inc. (2); Biodex Medical Systems, Inc. (1); Sra Intl., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KHX
- Run a recall and safety report across every KHX manufacturer
- Watch product code KHX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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