FDA product code IPS: Cane
IPS is the FDA product code for cane. It is a Class I device, regulated under 21 CFR 890.3075 and reviewed by the Physical Medicine panel. FDA has cleared 9 510(k) submissions under IPS, from 6 different applicants. The average 510(k) review took 15 days (median 15). FDA has posted 4 recalls for IPS devices.
Classification
| Field | Value |
|---|---|
| Device name | Cane |
| Device class | Class I |
| Regulation | 21 CFR 890.3075 |
| 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 IPS clearance
Top IPS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Maddak, Inc. | 4 | 1983-09-29 |
| Manuco Manufacturing Co., Inc. | 1 | 1982-04-21 |
| Guardian Products Co., Inc. | 1 | 1979-02-21 |
| Fred Sammons, Inc. | 1 | 1978-01-30 |
| Med Fusion Systems, Inc. | 1 | 1977-12-20 |
1 more applicants have IPS clearances. See the full list in Caduvo.
Most recent IPS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K832970 | Maddak, Inc. | CANE REACHER | 1983-09-29 | 28 |
| K832969 | Maddak, Inc. | WALKING CANE | 1983-09-29 | 28 |
| K821402 | Manuco Manufacturing Co., Inc. | LIGHT WEIGHT ALUMINUM CANES | 1982-04-21 | 0 |
| K790561 | Maddak, Inc. | OFFSET ALUMINUM CANE | 1979-04-03 | 15 |
| K790558 | Maddak, Inc. | CERSA-CANE | 1979-04-03 | 15 |
Recalls for IPS devices
4 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2006-03-10.
Frequently asked questions
What is FDA product code IPS?
IPS is the FDA product code for cane. It is a Class I device, regulated under 21 CFR 890.3075 and reviewed by the Physical Medicine panel.
What device class is IPS?
Class I, regulation 21 CFR 890.3075. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IPS?
Across 9 cleared submissions the average was 15 days from receipt to decision (median 15).
Which companies have the most IPS clearances?
Maddak, Inc. (4); Manuco Manufacturing Co., Inc. (1); Guardian Products Co., Inc. (1); Fred Sammons, Inc. (1); Med Fusion Systems, Inc. (1).
Have IPS devices been recalled?
Yes: 4 product recalls across 1 recall events; the most recent began 2006-03-10.
Next steps
- Run an FDA pathway report with predicate devices for product code IPS
- Run a recall and safety report across every IPS manufacturer
- Watch product code IPS 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.
All Physical Medicine product codes · FDA product code lookup · 510(k) database search · 510(k) review times