Cane
A cane is a walking aid used to improve stability and reduce weight-bearing on a lower extremity during ambulation. It is classified as FDA Class 1, meaning it presents the lowest risk and is subject only to general controls. The product code is IPS, regulated under 21 CFR 890.3075, 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
- IPS
- Device Class
- FDA class 1
- Regulation Number
- 890.3075
- 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 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K832970 | CANE REACHER | Sep 29, 1983 | Substantially Equivalent | Maddak, Inc. |
| K832969 | WALKING CANE | Sep 29, 1983 | Substantially Equivalent | Maddak, Inc. |
| K821402 | LIGHT WEIGHT ALUMINUM CANES | Apr 21, 1982 | Substantially Equivalent | Manuco Manufacturing Co., Inc. |
| K790561 | OFFSET ALUMINUM CANE | Apr 03, 1979 | Substantially Equivalent | Maddak, Inc. |
| K790558 | CERSA-CANE | Apr 03, 1979 | Substantially Equivalent | Maddak, Inc. |
| K790299 | FOREARM-CANE | Feb 21, 1979 | Substantially Equivalent | Guardian Products Co., Inc. |
| K780085 | CANE/REACHER | Jan 30, 1978 | Substantially Equivalent | Fred Sammons, Inc. |
| K772267 | QUADRAPLEGIC WALKING AID | Dec 20, 1977 | Substantially Equivalent | Med Fusion Systems, Inc. |
| K770529 | UNICET I | Apr 05, 1977 | Substantially Equivalent | Union Carbide Corp. |
FEI Numbers
This FDA classification entry is associated with 169 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 169 registration numbers. Click on an entry to view related FDA registrations.