FDA product code IPT: Orthosis, Thoracic
IPT is the FDA product code for orthosis, thoracic. It is a Class I device, regulated under 21 CFR 890.3490 and reviewed by the Physical Medicine panel. FDA has cleared 5 510(k) submissions under IPT, from 4 different applicants. The average 510(k) review took 46 days (median 25).
Classification
| Field | Value |
|---|---|
| Device name | Orthosis, Thoracic |
| Device class | Class I |
| Regulation | 21 CFR 890.3490 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Top IPT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fred Sammons, Inc. | 2 | 1982-06-11 |
| Hill-Rom, Inc. | 1 | 1997-01-09 |
| Surgical Appliance Industries, Inc. | 1 | 1981-09-14 |
| Roger Cestac & Assoc. | 1 | 1981-07-20 |
Most recent IPT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K963091 | Hill-Rom, Inc. | VOLLMAN PRONE POSITIONER | 1997-01-09 | 154 |
| K821645 | Fred Sammons, Inc. | BACK SKPPORTS | 1982-06-11 | 8 |
| K812401 | Surgical Appliance Industries, Inc. | CRUCIFORM ANTERIOR SPINAL HYPEREXTEN. O | 1981-09-14 | 25 |
| K811750 | Roger Cestac & Assoc. | MULTITUBULAR THORACIC AIR SPLINTS | 1981-07-20 | 28 |
| K761128 | Fred Sammons, Inc. | LATERAL TRUNK SUPPORTS | 1976-12-02 | 13 |
Recalls for IPT devices
openFDA lists no recalls for product code IPT.
Frequently asked questions
What is FDA product code IPT?
IPT is the FDA product code for orthosis, thoracic. It is a Class I device, regulated under 21 CFR 890.3490 and reviewed by the Physical Medicine panel.
What device class is IPT?
Class I, regulation 21 CFR 890.3490. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IPT?
Across 5 cleared submissions the average was 46 days from receipt to decision (median 25).
Which companies have the most IPT clearances?
Fred Sammons, Inc. (2); Hill-Rom, Inc. (1); Surgical Appliance Industries, Inc. (1); Roger Cestac & Assoc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IPT
- Run a recall and safety report across every IPT manufacturer
- Watch product code IPT 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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