Shoe, Cast
A Cast Shoe is a protective footwear device used in Physical Medicine and orthopedics worn over a lower leg cast or walking boot to protect the cast from damage and facilitate limited weight-bearing ambulation, enabling patients with lower limb fractures or post-surgical casts to walk safely. It is classified as FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. The product code is IPG, regulated under 21 CFR 890.3025, within the Physical Medicine medical specialty. This device is GMP exempt, indicating it is not subject to full good manufacturing practice requirements.
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Basic Information
- Product Code
- IPG
- Device Class
- FDA class 1
- Regulation Number
- 890.3025
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K024279 | NESS CHILDREN SYSTEM | Feb 05, 2003 | Substantially Equivalent | Ness-Neuromuscular Electrical Stimulation Systems |
| K790652 | TOGUARD | Apr 04, 1979 | Substantially Equivalent | Togard, Inc. |
| K781363 | CAST SHOE | Aug 14, 1978 | Substantially Equivalent | Cutler Biomedical |
| K780617 | EQUALIZER | Apr 18, 1978 | Substantially Equivalent | Ballert Orthopedic Corp. |
| K760575 | ROCKER-SOLE CAST SANDAL | Oct 06, 1976 | Substantially Equivalent | Richard'S Medical Equip., Inc. |
| K760578 | BALANCED CAST SOLE | Sep 27, 1976 | Substantially Equivalent | Parke-Davis Co. |
FEI Numbers
This FDA classification entry is associated with 93 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 93 registration numbers. Click on an entry to view related FDA registrations.