PROTECTIVE RESTRAINT
FDA 510(k) clearance K963492 · decided 1996-11-12
Clearance details
- K-number
- K963492
- Device name
- PROTECTIVE RESTRAINT
- Applicant
- Smith and Nephew Donjoy, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-09-03
- Decision date
- 1996-11-12
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- FMQ
- Device class
- 1
- Regulation number
- 880.6760
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Vista, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Smith and Nephew Donjoy
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PROTECTIVE RESTRAINT (K110377) | Medi-Tech Intl. Corp. | 2011-04-25 |
| STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002 (K081264) | Children'S Health First, Inc. | 2009-02-13 |
| CENTURION PROTECTIVE RESTRAINT, SCR SERIES (K080448) | Tri-State Hospital Supply Corp. | 2008-08-28 |
| COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES (K013239) | Med Gen, Inc. | 2001-11-20 |
| INFANT LIMB HOLDER, MODELS 306080 & 306081 (K010818) | Skil-Care Corp. | 2001-05-24 |
| CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025 (K010644) | Skil-Care Corp. | 2001-05-18 |
| BIOTHANE PATIENT RESTRAINT (K991591) | Bioplastics | 1999-07-29 |
| VAGABOND SOFT RESTRAINT SYSTEM (K982178) | Emergent Innovations, Ltd. | 1999-01-26 |
| HEELBO WAIST AND CHEST VEST (K980640) | Heelbo, Inc. | 1998-05-01 |
| PEDO CUSH PEDO CUDDLE (K972446) | Cavity Free Kids, Inc. | 1997-11-13 |
| FULL BODY RESTRAINT SYSTEM (K972046) | Gillen Industries | 1997-08-15 |
| PATIENT RESTRAINT (K971948) | E.M. Adams Co., Inc. | 1997-08-06 |
Recalls involving this device
No recalls on record reference this clearance.