FDA product code INW: Table, Mechanical
INW is the FDA product code for table, mechanical. It is a Class I device, regulated under 21 CFR 890.3750 and reviewed by the Physical Medicine panel. FDA has cleared 35 510(k) submissions under INW, from 26 different applicants. The average 510(k) review took 49 days (median 28). FDA has posted 1 recall for INW devices.
Classification
| Field | Value |
|---|---|
| Device name | Table, Mechanical |
| Device class | Class I |
| Regulation | 21 CFR 890.3750 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every INW clearance
Top INW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bailey Mfg. Co. | 4 | 1993-07-22 |
| Rifton Equipment For the Handicapped | 4 | 1989-05-09 |
| James Leckey Design | 2 | 1994-12-22 |
| Progressive Electrical Therapeutics | 2 | 1994-09-29 |
| Titan Tables | 2 | 1990-06-11 |
21 more applicants have INW clearances. See the full list in Caduvo.
Most recent INW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K944307 | James Leckey Design | JAMES LECKEY PRONE STANDER | 1994-12-22 | 111 |
| K944308 | James Leckey Design | JAMES LECKEY FREE STANDER | 1994-12-22 | 111 |
| K943974 | Progressive Electrical Therapeutics | EURO TECH MARQUISE CHIROPRACTIC TABLE | 1994-09-29 | 45 |
| K943975 | Progressive Electrical Therapeutics | EURO TECH PLATINUM CHIROPRACTIC TABLE | 1994-09-29 | 45 |
| K940238 | Camp Intl., Inc. | TUMBLE FORMS JUNIOR TRISTANDER | 1994-03-07 | 47 |
Recalls for INW devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2003-05-30.
Frequently asked questions
What is FDA product code INW?
INW is the FDA product code for table, mechanical. It is a Class I device, regulated under 21 CFR 890.3750 and reviewed by the Physical Medicine panel.
What device class is INW?
Class I, regulation 21 CFR 890.3750. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code INW?
Across 35 cleared submissions the average was 49 days from receipt to decision (median 28).
Which companies have the most INW clearances?
Bailey Mfg. Co. (4); Rifton Equipment For the Handicapped (4); James Leckey Design (2); Progressive Electrical Therapeutics (2); Titan Tables (2).
Have INW devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2003-05-30.
Next steps
- Run an FDA pathway report with predicate devices for product code INW
- Run a recall and safety report across every INW manufacturer
- Watch product code INW 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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