FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HEEL PROTECTOR
K Number: K771633
·
Decision Sep 12, 1977
Classifications
1
FEI Numbers
374
Registration Numbers
374
Same Product Code
22
Applicant Total
10
Review Days
17
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Basic Information
- Device Name
- HEEL PROTECTOR
- K Number
- K771633
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6450
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Medical Restraints, Inc.
- Date Received
- August 26, 1977
- Decision Date
- September 12, 1977
- Product Code
- FMP
- 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 |
|---|---|---|---|
| FMP | Protector, Skin Pressure | FDA class 1 | General Hospital |
Similar 510(k) Clearances
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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 |
| K771635 | FOOT ELEVATOR | Sep 28, 1977 | Substantially Equivalent |
| K771676 | FOOT DROP BOOT | Sep 20, 1977 | Substantially Equivalent |
| K771631 | WHEELCHAIR SAFETY BELT | Sep 12, 1977 | Substantially Equivalent |