FDA product code IRO: Vibrator, Therapeutic
IRO is the FDA product code for vibrator, therapeutic. It is a Class I device, regulated under 21 CFR 890.5975 and reviewed by the Physical Medicine panel. FDA has cleared 65 510(k) submissions under IRO, from 35 different applicants. The average 510(k) review took 143 days (median 78). FDA has posted 2 recalls for IRO devices.
Classification
| Field | Value |
|---|---|
| Device name | Vibrator, Therapeutic |
| Device class | Class I |
| Regulation | 21 CFR 890.5975 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every IRO clearance
Top IRO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Conair Corp. | 12 | 1995-07-18 |
| Fairform Mfg., Co., Ltd. | 11 | 1994-03-28 |
| Fred Sammons, Inc. | 5 | 1982-06-11 |
| Wahl Clipper Corp. | 3 | 1995-05-08 |
| Windmere Corp. | 3 | 1994-02-02 |
30 more applicants have IRO clearances. See the full list in Caduvo.
Most recent IRO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K955250 | East Health Development Group, Inc. | QI GONG MASSAGER | 1996-02-08 | 87 |
| K955160 | Everapex Design & Marketing Corp. | COMFORT, MUSCLE, CORDLESS MASSAGER, BATTERY POWERED OPERATED MASSAGER | 1996-02-08 | 87 |
| K954203 | Cisco Sales Corp. | MASSAGER THERAPUTIC, ELECTRIC | 1995-12-11 | 95 |
| K952916 | Kinsei Shiatsu, Inc. | SHIATSU MASTER MASSAGER CUSHION | 1995-08-28 | 63 |
| K951414 | Champion Mfg. Corp. | CHAMPION PHYSIOACOUSTICC RECLINER-TRANSPORTER CHAIR | 1995-08-11 | 137 |
Recalls for IRO devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2012-05-07.
Frequently asked questions
What is FDA product code IRO?
IRO is the FDA product code for vibrator, therapeutic. It is a Class I device, regulated under 21 CFR 890.5975 and reviewed by the Physical Medicine panel.
What device class is IRO?
Class I, regulation 21 CFR 890.5975. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IRO?
Across 65 cleared submissions the average was 143 days from receipt to decision (median 78).
Which companies have the most IRO clearances?
Conair Corp. (12); Fairform Mfg., Co., Ltd. (11); Fred Sammons, Inc. (5); Wahl Clipper Corp. (3); Windmere Corp. (3).
Have IRO devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2012-05-07.
Next steps
- Run an FDA pathway report with predicate devices for product code IRO
- Run a recall and safety report across every IRO manufacturer
- Watch product code IRO 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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