510(k) K962963
- Device
- CHECKMATE ANKLE RESTRAINT SYSTEM
- Applicant
- HOLLISTER, INC.
- 510(k) number
- K962963
- Product code
- FMQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-10-24
- Date received
- 1996-07-30
- Regulation
- 880.6760
- Classification name
- Restraint, Protective
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOSEPH S TOKARZ
- Address
- 2000 Hollister Dr. Libertyville IL US 60048 60048
FDA Registration Numbers#
- 9681385
- 3006251250
- 3015173212
- 1053198
- 2182318
- 2921578
- 3032534
- 1724810
- 3005082755
- 3013035022
- 3015397169
- 3031582434
- 1026765
- 3013195449
- 3007774549
- 3003495693
- 3004198457
- 3004425765
- 2011171
- 3010699203
- 3013180212
- 3012205931
- 1054241
- 1523530
- 9681527
- 3043051412
- 3008797789
- 3020188747
- 3010453133
- 3010865220
- 9680215
- 3004519921
- 3006336810
- 3033858895
- 1929691
- 1422634
- 3016674288
- 9616086
- 1055236
- 3006089112
- 3008973893
- 1531186
- 3008381107
- 1720747
- 3006400320
- 3013856565
- 1054236
- 3005831263
- 3042176500
- 3014680784
- 3004183518
- 3015277818
- 3014925393
- 2027062
- 3014926389
- 3016678045
- 3042941605
- 3017299798
- 1060680
- 1422443
- 2320762
- 1043214
- 3010359088
- 3010452421
- 1054786
- 3017264244
- 1417592
- 3004125670
- 3003102481
- 8021894
- 3015058854
- 1824619
- 3011191255
- 1926174
- 3016761372
- 1835377
- 3008403546
- 3021135929
- 3023812384
Source Documents#
Other 510(k) Records For Product Code FMQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K110377 | PROTECTIVE RESTRAINT | Medi-Tech Intl. Corp. | 2011-04-25 |
| K081264 | STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002 | Children'S Health First, Inc. | 2009-02-13 |
| K080448 | CENTURION PROTECTIVE RESTRAINT, SCR SERIES | Tri-State Hospital Supply Corp. | 2008-08-28 |
| K013239 | COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES | Med Gen, Inc. | 2001-11-20 |
| K010818 | INFANT LIMB HOLDER, MODELS 306080 & 306081 | Skil-Care Corp. | 2001-05-24 |
| K010644 | CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025 | Skil-Care Corp. | 2001-05-18 |
| K991591 | BIOTHANE PATIENT RESTRAINT | Bioplastics | 1999-07-29 |
| K982178 | VAGABOND SOFT RESTRAINT SYSTEM | Emergent Innovations, Ltd. | 1999-01-26 |
| K980640 | HEELBO WAIST AND CHEST VEST | Heelbo, Inc. | 1998-05-01 |
| K972446 | PEDO CUSH PEDO CUDDLE | Cavity Free Kids, Inc. | 1997-11-13 |
| K972046 | FULL BODY RESTRAINT SYSTEM | Gillen Industries | 1997-08-15 |
| K971948 | PATIENT RESTRAINT | E.M. Adams Co., Inc. | 1997-08-06 |
| K972123 | PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905 | Smith | 1997-07-25 |
| K971742 | DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINT | Depuy, Inc. | 1997-07-24 |
| K972338 | PROTECTIVE RESTRAINT(MODELS #302,440,750 AND A30 X 30 BELT. | Geriatric Products, Inc. | 1997-07-24 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases