FDA product code FMQ: Restraint, Protective
FMQ is the FDA product code for restraint, protective. It is a Class I device, regulated under 21 CFR 880.6760 and reviewed by the General Hospital panel. FDA has cleared 134 510(k) submissions under FMQ, from 46 different applicants. The average 510(k) review took 74 days (median 72). FDA has posted 33 recalls for FMQ devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Restraint, Protective |
| Device class | Class I |
| Regulation | 21 CFR 880.6760 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FMQ clearance
Top FMQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Deroyal Industries, Inc. | 15 | 1997-02-13 |
| Heelbo, Inc. | 14 | 1998-05-01 |
| Skil-Care Corp. | 12 | 2001-05-24 |
| J. T. Posey Co. | 9 | 1996-11-22 |
| Tecnol Medical Products, Inc. | 9 | 1996-11-22 |
41 more applicants have FMQ clearances. See the full list in Caduvo.
Most recent FMQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K110377 | Medi-Tech Intl. Corp. | PROTECTIVE RESTRAINT | 2011-04-25 | 75 |
| K081264 | Children'S Health First, Inc. | STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002 | 2009-02-13 | 284 |
| K080448 | Tri-State Hospital Supply Corp. | CENTURION PROTECTIVE RESTRAINT, SCR SERIES | 2008-08-28 | 191 |
| K013239 | Med Gen, Inc. | COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES | 2001-11-20 | 53 |
| K010818 | Skil-Care Corp. | INFANT LIMB HOLDER, MODELS 306080 & 306081 | 2001-05-24 | 66 |
Recalls for FMQ devices
33 product recalls in 11 recall events; 1 initiated in the last five years and 0 still open. Most recent: 2022-07-15.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code FMQ?
FMQ is the FDA product code for restraint, protective. It is a Class I device, regulated under 21 CFR 880.6760 and reviewed by the General Hospital panel.
What device class is FMQ?
Class I, regulation 21 CFR 880.6760. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FMQ?
Across 134 cleared submissions the average was 74 days from receipt to decision (median 72).
Which companies have the most FMQ clearances?
Deroyal Industries, Inc. (15); Heelbo, Inc. (14); Skil-Care Corp. (12); J. T. Posey Co. (9); Tecnol Medical Products, Inc. (9).
Have FMQ devices been recalled?
Yes: 33 product recalls across 11 recall events; the most recent began 2022-07-15.
Next steps
- Run an FDA pathway report with predicate devices for product code FMQ
- Run a recall and safety report across every FMQ manufacturer
- Watch product code FMQ 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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