FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HEELBO QUILTED LIMB HOLDER WITH DOUBLE D-RING, QUICK-RELEASE SNAP, AND STRAP
K Number: K962834
·
Decision Oct 18, 1996
Classifications
1
FEI Numbers
109
Registration Numbers
109
Same Product Code
133
Applicant Total
14
Review Days
88
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Basic Information
- Device Name
- HEELBO QUILTED LIMB HOLDER WITH DOUBLE D-RING, QUICK-RELEASE SNAP, AND STRAP
- K Number
- K962834
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6760
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Heelbo, Inc.
- Date Received
- July 22, 1996
- Decision Date
- October 18, 1996
- Product Code
- FMQ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FMQ | Restraint, Protective | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FMQ), ordered by most recent decision date.
PROTECTIVE RESTRAINT
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STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002
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CENTURION PROTECTIVE RESTRAINT, SCR SERIES
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COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES
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INFANT LIMB HOLDER, MODELS 306080 & 306081
FDA 510(k)
FDA Class 1
·General Hospital
CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by Heelbo, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K980640 | HEELBO WAIST AND CHEST VEST | May 1, 1998 | Substantially Equivalent |
| K963372 | HEELBO ER WRIST RESTRAINT | Nov 7, 1996 | Substantially Equivalent |
| K963060 | HEELBO SECURITY BELT | Nov 4, 1996 | Substantially Equivalent |
| K963099 | HEELBO PULLOVER PONCHO AND PULLOVER PONCHO WITH POCKET | Nov 1, 1996 | Substantially Equivalent |
| K963041 | HEELBO LIFE JACKET WITH CROTCH SUPPORT | Oct 31, 1996 | Substantially Equivalent |
| K962832 | HEELBO QUILTED LIMB HOLDER WITH DOUBLE D-RING AND STRAP | Oct 18, 1996 | Substantially Equivalent |
| K962839 | HEELBO QUILTED LIMB HOLDER WITH BUCKLE AND STRAP | Oct 18, 1996 | Substantially Equivalent |
| K962831 | THE INCH QUILTED LIMB HOLDER WITH QUICK RELEASE SNAP CLOSURE | Oct 18, 1996 | Substantially Equivalent |
| K963294 | HEELBO WRAP AROUND VEST | Oct 11, 1996 | Substantially Equivalent |
| K962778 | THE L-BOW ARM RESTRAINT | Oct 9, 1996 | Substantially Equivalent |