FDA Product Code
FDA Product Code FMQ — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.6760
510(k) Clearances — 134 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K963463 | STRAIT JACKET | Deroyal Industries, Inc. | 1996-10-16 | Traditional | PDF ↗ |
| K963294 | HEELBO WRAP AROUND VEST | Heelbo, Inc. | 1996-10-11 | Traditional | PDF ↗ |
| K963108 | HEELBO QUILTED TORSO RESTRAINT | Hollister, Inc. | 1996-10-09 | Traditional | PDF ↗ |
| K963237 | HEELBO ICU 911 BLAZER SLEEVED JACKET | Heelbo, Inc. | 1996-10-09 | Traditional | PDF ↗ |
| K962810 | GREAT HANDS MITTS | Heelbo, Inc. | 1996-10-09 | Traditional | PDF ↗ |
| K963457 | SLEEPER JACKET/HOUDINI SAFETY SLEEPER | Skil-Care Corp. | 1996-10-09 | Traditional | PDF ↗ |
| K963460 | ROLL BELT | Skil-Care Corp. | 1996-10-09 | Traditional | PDF ↗ |
| K962778 | THE L-BOW ARM RESTRAINT | Heelbo, Inc. | 1996-10-09 | Traditional | PDF ↗ |
| K963456 | LIMB HOLDERS-REUSABLE/LIMB HOLDERS-DISPOSABLE/QUICK-CUFF LIMB HOLDER | Skil-Care Corp. | 1996-10-08 | Traditional | PDF ↗ |
| K963449 | PELVIC HOLDER | Skil-Care Corp. | 1996-10-07 | Traditional | PDF ↗ |
| K963450 | SAFETY VEST/SHOULDER STRAP VEST/ECONOMY SAFETY VEST | Skil-Care Corp. | 1996-10-07 | Traditional | PDF ↗ |
| K963448 | ECONO BELT | Skil-Care Corp. | 1996-10-07 | Traditional | PDF ↗ |
| K963447 | DOUBLE SUPPORT PONCHO/SLIDER PONCHO | Skil-Care Corp. | 1996-10-07 | Traditional | PDF ↗ |
| K963454 | CUSHION BELT/CUSHION SLIDER BELT/ADJUSTA-LOOP CUSHION BELT/QUICK RELEASE CUSHION BELT | Skil-Care Corp. | 1996-10-07 | Traditional | PDF ↗ |
| K962626 | PATIENT PROTECTIVE LIMB | Kenad SG Medical, Inc. | 1996-10-02 | Traditional | PDF ↗ |
| K963243 | HEELBO BLAZER SLEEVED JACKET | Heelbo, Inc. | 1996-10-01 | Traditional | PDF ↗ |
| K962429 | SAFETY VEST | Johnson & Johnson Professionals, Inc. | 1996-09-18 | Traditional | PDF ↗ |
| K925924 | NEAL WRIST CONES | Neal & Assoc., Inc. | 1993-04-08 | Traditional | PDF ↗ |
| K850470 | BED PRODUCTS | Abco Dealers, Inc. | 1985-04-01 | Traditional | PDF ↗ |
| K812473 | HEAD PROTECTOR | Maddak, Inc. | 1981-12-02 | Traditional | PDF ↗ |
| K801272 | TECNOL QUICK RELEASE LIMB HOLDER | Tecnol New Jersey Wound Care, Inc. | 1980-06-17 | Traditional | PDF ↗ |
| K792012 | SKIL-CARE SUPER-SOFT LIMB RESTRAINTS | Skil-Care Corp. | 1979-10-26 | Traditional | PDF ↗ |
| K790699 | TECNOL BODY HOLDER | Tecnol New Jersey Wound Care, Inc. | 1979-06-01 | Traditional | PDF ↗ |
| K790172 | BK-5098 TILT TABLE STRAP | Fred Sammons, Inc. | 1979-02-27 | Traditional | PDF ↗ |
| K780232 | RESTRAINT, PROTECTIVE | Biomet, Inc. | 1978-02-21 | Traditional | PDF ↗ |
| K771630 | LIMB RESTRAINT | Medical Restraints, Inc. | 1977-09-30 | Traditional | PDF ↗ |
| K771636 | BODY RESTRAINT | Medical Restraints, Inc. | 1977-09-30 | Traditional | PDF ↗ |
| K771659 | PATIENT RESTRAINT SYSTEM | Mtd, Inc. | 1977-09-30 | Traditional | PDF ↗ |
| K771629 | HAND RESTRAINT | Medical Restraints, Inc. | 1977-09-30 | Traditional | PDF ↗ |
| K771715 | PELVIC WHEELCHAIR RESTRAINT | Medical Restraints, Inc. | 1977-09-28 | Traditional | PDF ↗ |
| K771634 | VEST RESTRAINT | Medical Restraints, Inc. | 1977-09-28 | Traditional | PDF ↗ |
| K771635 | FOOT ELEVATOR | Medical Restraints, Inc. | 1977-09-28 | Traditional | PDF ↗ |
| K771632 | FINGER MITT RESTRAINT | Medical Restraints, Inc. | 1977-09-28 | Traditional | PDF ↗ |
| K760618 | PATIENT RESTRAINT | Encompass Group, LLC | 1976-11-24 | Traditional | PDF ↗ |
Product code FMQ · Class I · General Hospital. Data: openFDA.