FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HEAVY FOAM HEEL & ELBOW PROTECTORS
K Number: K770223
·
Decision Feb 23, 1977
Classifications
1
FEI Numbers
148
Registration Numbers
148
Same Product Code
5
Applicant Total
5
Review Days
20
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Basic Information
- Device Name
- HEAVY FOAM HEEL & ELBOW PROTECTORS
- K Number
- K770223
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3025
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Robert R. Moore
- Date Received
- February 3, 1977
- Decision Date
- February 23, 1977
- Product Code
- IPM
- 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 |
|---|---|---|---|
| IPM | Cover, Limb | FDA class 1 | Physical Medicine |
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Other Clearances by Robert R. Moore
| K Number | Device Name | ||
|---|---|---|---|
| K770658 | EXERCISER, LEG, LOWER EXTREMITY | Jun 17, 1977 | Substantially Equivalent |
| K770501 | KNEE CUFF FOR EXPRESSING FLUID | Apr 5, 1977 | Substantially Equivalent |
| K770060 | X-RAY POSITIONING DEVICE | Jan 24, 1977 | Substantially Equivalent |
| K770059 | ORTHOPEDIC SPECIALTIES | Jan 14, 1977 | Substantially Equivalent |