FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FOOT DROP BOOT
K Number: K771676
·
Decision Sep 20, 1977
Classifications
1
FEI Numbers
503
Registration Numbers
503
Same Product Code
51
Applicant Total
10
Review Days
18
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Basic Information
- Device Name
- FOOT DROP BOOT
- K Number
- K771676
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3475
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Medical Restraints, Inc.
- Date Received
- September 2, 1977
- Decision Date
- September 20, 1977
- Product Code
- IQI
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| IQI | Orthosis, Limb Brace | FDA class 1 | Physical Medicine |
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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 |
| K771631 | WHEELCHAIR SAFETY BELT | Sep 12, 1977 | Substantially Equivalent |
| K771633 | HEEL PROTECTOR | Sep 12, 1977 | Substantially Equivalent |