FDA product code ION: Exerciser, Non-Measuring
ION is the FDA product code for exerciser, non-measuring. It is a Class I device, regulated under 21 CFR 890.5370 and reviewed by the Physical Medicine panel. FDA has cleared 43 510(k) submissions under ION, from 18 different applicants. The average 510(k) review took 33 days (median 22). FDA has posted 2 recalls for ION devices.
Classification
| Field | Value |
|---|---|
| Device name | Exerciser, Non-Measuring |
| Device class | Class I |
| Regulation | 21 CFR 890.5370 |
| 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 ION clearance
Top ION applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fred Sammons, Inc. | 18 | 1983-06-24 |
| Maddak, Inc. | 7 | 1983-11-29 |
| Lossing Orthopedic, Inc. | 2 | 1984-03-23 |
| Hosmer Dorrance Corp. | 2 | 1977-01-10 |
| Im-Able, Ltd. | 1 | 2012-06-20 |
13 more applicants have ION clearances. See the full list in Caduvo.
Most recent ION clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K120783 | Im-Able, Ltd. | ABLE-X | 2012-06-20 | 97 |
| K885343 | Alt, Inc. | STANDEX | 1989-05-01 | 124 |
| K851065 | Unique Functional Products | GRAVITY KING (DEEMED SE 87/09/18) | 1985-06-13 | 90 |
| K840551 | Lossing Orthopedic, Inc. | MOBILIZER | 1984-03-23 | 44 |
| K833870 | Maddak, Inc. | KNEE WALKER | 1983-11-29 | 21 |
Recalls for ION devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-03-27.
Frequently asked questions
What is FDA product code ION?
ION is the FDA product code for exerciser, non-measuring. It is a Class I device, regulated under 21 CFR 890.5370 and reviewed by the Physical Medicine panel.
What device class is ION?
Class I, regulation 21 CFR 890.5370. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ION?
Across 43 cleared submissions the average was 33 days from receipt to decision (median 22).
Which companies have the most ION clearances?
Fred Sammons, Inc. (18); Maddak, Inc. (7); Lossing Orthopedic, Inc. (2); Hosmer Dorrance Corp. (2); Im-Able, Ltd. (1).
Have ION devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2015-03-27.
Next steps
- Run an FDA pathway report with predicate devices for product code ION
- Run a recall and safety report across every ION manufacturer
- Watch product code ION 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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