Cover, Limb
A Limb Cover is a protective sleeve or covering used in Physical Medicine to protect a limb, cast, orthosis, or prosthetic device during bathing, wound care, or other activities, preventing contamination or damage to the underlying device or skin. 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 IPM, 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
- IPM
- 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 |
|---|---|---|---|---|
| K872488 | ELASTO-GEL CAST & SPLINT PADS | Sep 21, 1987 | Substantially Equivalent for Some Indications | Southwest Technologies, Inc. |
| K823399 | COVER LIMB | Nov 29, 1982 | Substantially Equivalent | Orthopedic Systems, Inc. |
| K801627 | COVER, LIMB | Jul 28, 1980 | Substantially Equivalent | The Owenby Co. |
| K780905 | LIMB COVER | Aug 14, 1978 | Substantially Equivalent | Hydro-Med Products, Inc. |
| K770223 | HEAVY FOAM HEEL & ELBOW PROTECTORS | Feb 23, 1977 | Substantially Equivalent | Robert R. Moore |
| K761114 | FOAM SLIPPERS | Dec 02, 1976 | Substantially Equivalent | Fred Sammons, Inc. |
FEI Numbers
This FDA classification entry is associated with 148 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 148 registration numbers. Click on an entry to view related FDA registrations.