FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FOOT ELEVATOR
K Number: K771635
·
Decision Sep 28, 1977
Classifications
1
FEI Numbers
109
Registration Numbers
109
Same Product Code
133
Applicant Total
10
Review Days
33
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- FOOT ELEVATOR
- K Number
- K771635
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6760
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Medical Restraints, Inc.
- Date Received
- August 26, 1977
- Decision Date
- September 28, 1977
- 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
FDA 510(k)
FDA Class 1
·General Hospital
STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002
FDA 510(k)
FDA Class 1
·General Hospital
CENTURION PROTECTIVE RESTRAINT, SCR SERIES
FDA 510(k)
FDA Class 1
·General Hospital
COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES
FDA 510(k)
FDA Class 1
·General Hospital
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 Medical Restraints, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K771636 | BODY RESTRAINT | Sep 30, 1977 | Substantially Equivalent |
| K771630 | LIMB RESTRAINT | Sep 30, 1977 | Substantially Equivalent |
| K771629 | HAND RESTRAINT | Sep 30, 1977 | Substantially Equivalent |
| K771634 | VEST RESTRAINT | Sep 28, 1977 | Substantially Equivalent |
| K771715 | PELVIC WHEELCHAIR RESTRAINT | Sep 28, 1977 | Substantially Equivalent |
| K771632 | FINGER MITT RESTRAINT | Sep 28, 1977 | Substantially Equivalent |
| K771676 | FOOT DROP BOOT | Sep 20, 1977 | Substantially Equivalent |
| K771631 | WHEELCHAIR SAFETY BELT | Sep 12, 1977 | Substantially Equivalent |
| K771633 | HEEL PROTECTOR | Sep 12, 1977 | Substantially Equivalent |