FDA product code INP: Tips And Pads, Cane, Crutch And Walker
INP is the FDA product code for tips and pads, cane, crutch and walker. It is a Class I device, regulated under 21 CFR 890.3790 and reviewed by the Physical Medicine panel. FDA has cleared 8 510(k) submissions under INP, from 6 different applicants. The average 510(k) review took 22 days (median 24). FDA has posted 9 recalls for INP devices.
Classification
| Field | Value |
|---|---|
| Device name | Tips And Pads, Cane, Crutch And Walker |
| Device class | Class I |
| Regulation | 21 CFR 890.3790 |
| 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 INP clearance
Top INP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Conphar, Inc. | 3 | 1981-01-08 |
| W.K. Wheeler, Inc. | 1 | 1983-07-07 |
| Tecnol New Jersey Wound Care, Inc. | 1 | 1983-05-03 |
| Fred Sammons, Inc. | 1 | 1981-06-12 |
| First Industries, Inc. | 1 | 1981-03-26 |
1 more applicants have INP clearances. See the full list in Caduvo.
Most recent INP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K831889 | W.K. Wheeler, Inc. | SURGEON'S CHOICE CRUTCH HANDLE | 1983-07-07 | 23 |
| K831149 | Tecnol New Jersey Wound Care, Inc. | PERSONAL KNEE CRUTCH PAD | 1983-05-03 | 25 |
| K811493 | Fred Sammons, Inc. | CRUTCH & WALKER PADS | 1981-06-12 | 17 |
| K810650 | First Industries, Inc. | CRUTCH TIPS & GRIPS | 1981-03-26 | 16 |
| K803136 | Conphar, Inc. | CONPHAR CRUTCH TIPS | 1981-01-08 | 27 |
Recalls for INP devices
9 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-02-17.
Frequently asked questions
What is FDA product code INP?
INP is the FDA product code for tips and pads, cane, crutch and walker. It is a Class I device, regulated under 21 CFR 890.3790 and reviewed by the Physical Medicine panel.
What device class is INP?
Class I, regulation 21 CFR 890.3790. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code INP?
Across 8 cleared submissions the average was 22 days from receipt to decision (median 24).
Which companies have the most INP clearances?
Conphar, Inc. (3); W.K. Wheeler, Inc. (1); Tecnol New Jersey Wound Care, Inc. (1); Fred Sammons, Inc. (1); First Industries, Inc. (1).
Have INP devices been recalled?
Yes: 9 product recalls across 2 recall events; the most recent began 2016-02-17.
Next steps
- Run an FDA pathway report with predicate devices for product code INP
- Run a recall and safety report across every INP manufacturer
- Watch product code INP 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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