VAGABOND SOFT RESTRAINT SYSTEM
FDA 510(k) clearance K982178 · decided 1999-01-26
Clearance details
- K-number
- K982178
- Device name
- VAGABOND SOFT RESTRAINT SYSTEM
- Applicant
- Emergent Innovations, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1998-06-22
- Decision date
- 1999-01-26
- Days to decision
- 218 days
- Clearance type
- Traditional
- Product code
- FMQ
- Device class
- 1
- Regulation number
- 880.6760
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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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 |
| 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 |
| PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905 (K972123) | Smith | 1997-07-25 |
Recalls involving this device
No recalls on record reference this clearance.