FDA product code INT: Plinth
INT is the FDA product code for plinth. It is a Class I device, regulated under 21 CFR 890.3520 and reviewed by the Physical Medicine panel. FDA has cleared 4 510(k) submissions under INT, from 3 different applicants. The average 510(k) review took 30 days (median 15). FDA has posted 5 recalls for INT devices.
Classification
| Field | Value |
|---|---|
| Device name | Plinth |
| Device class | Class I |
| Regulation | 21 CFR 890.3520 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every INT clearance
Top INT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Will Ross Co. | 2 | 1977-04-08 |
| Chattanooga Pharmacal Co. | 1 | 1977-07-11 |
| I E Industries | 1 | 1977-04-15 |
Most recent INT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K770723 | Chattanooga Pharmacal Co. | TABLE, TREATMENT, THERAPY, PHYSICAL | 1977-07-11 | 83 |
| K770636 | I E Industries | TABLE, EXAM & MANUPULATION | 1977-04-15 | 11 |
| K770609 | Will Ross Co. | TABLE, MASSAGE & TREATMHNT, FIXED HEIGHT | 1977-04-08 | 8 |
| K770509 | Will Ross Co. | TABLE, MASSAGE AND TREATMENT | 1977-04-05 | 19 |
Recalls for INT devices
5 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2006-01-25.
Frequently asked questions
What is FDA product code INT?
INT is the FDA product code for plinth. It is a Class I device, regulated under 21 CFR 890.3520 and reviewed by the Physical Medicine panel.
What device class is INT?
Class I, regulation 21 CFR 890.3520. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code INT?
Across 4 cleared submissions the average was 30 days from receipt to decision (median 15).
Which companies have the most INT clearances?
Will Ross Co. (2); Chattanooga Pharmacal Co. (1); I E Industries (1).
Have INT devices been recalled?
Yes: 5 product recalls across 1 recall events; the most recent began 2006-01-25.
Next steps
- Run an FDA pathway report with predicate devices for product code INT
- Run a recall and safety report across every INT manufacturer
- Watch product code INT 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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