FMQ — Restraint, Protective Class I
FDA Device Classification
Classification Details
- Product Code
- FMQ
- Device Class
- Class I
- Regulation Number
- 880.6760
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K110377 | medi-tech intl | PROTECTIVE RESTRAINT | April 25, 2011 |
| K081264 | children health first | STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002 | February 13, 2009 |
| K080448 | tri-state hospital supply | CENTURION PROTECTIVE RESTRAINT, SCR SERIES | August 28, 2008 |
| K013239 | med gen | COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES | November 20, 2001 |
| K010818 | skil-care | INFANT LIMB HOLDER, MODELS 306080 & 306081 | May 24, 2001 |
| K010644 | skil-care | CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025 | May 18, 2001 |
| K991591 | bioplastics | BIOTHANE PATIENT RESTRAINT | July 29, 1999 |
| K982178 | emergent innovations | VAGABOND SOFT RESTRAINT SYSTEM | January 26, 1999 |
| K980640 | heelbo | HEELBO WAIST AND CHEST VEST | May 1, 1998 |
| K972446 | cavity free kids | PEDO CUSH PEDO CUDDLE | November 13, 1997 |
| K972046 | gillen industries | FULL BODY RESTRAINT SYSTEM | August 15, 1997 |
| K971948 | e.m. adams co | PATIENT RESTRAINT | August 6, 1997 |
| K972123 | smith | PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905 | July 25, 1997 |
| K972338 | geriatric products | PROTECTIVE RESTRAINT(MODELS #302,440,750 AND A30 X 30 BELT. | July 24, 1997 |
| K971742 | depuy | DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINT | July 24, 1997 |
| K971561 | jemm medical products | PROVEST-PROTECTIVE RESTRAINT | July 14, 1997 |
| K971536 | e.m. adams co | RESTRAINTS (VESTS AND JACKETS) | July 1, 1997 |
| K970274 | fla orthopedics | PATIENT RESTRAINTS | April 11, 1997 |
| K970273 | fla orthopedics | PATIENT RESTRAINTS | April 11, 1997 |
| K970272 | fla orthopedics | PATIENT RESTRAINT | April 11, 1997 |