IPS · Cane
Physical Medicine · 21 CFR 890.3075 · Class 1
Overview
| Product Code | IPS |
|---|---|
| Device Name | Cane |
| Regulation | 21 CFR 890.3075 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
| GMP Exempt | Yes |
Identification
A cane is a device intended for medical purposes that is used to provide minimal weight support while walking. Examples of canes include the following: A standard cane, a forearm cane, and a cane with a tripod, quad, or retractable stud on the ground end.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (9 of 9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K832970 | CANE REACHER | Maddak, Inc. | Sep 29, 1983 | SESE |
| K832969 | WALKING CANE | Maddak, Inc. | Sep 29, 1983 | SESE |
| K821402 | LIGHT WEIGHT ALUMINUM CANES | Manuco Manufacturing Co., Inc. | Apr 21, 1982 | SESE |
| K790561 | OFFSET ALUMINUM CANE | Maddak, Inc. | Apr 3, 1979 | SESE |
| K790558 | CERSA-CANE | Maddak, Inc. | Apr 3, 1979 | SESE |
| K790299 | FOREARM-CANE | Guardian Products Co., Inc. | Feb 21, 1979 | SESE |
| K780085 | CANE/REACHER | Fred Sammons, Inc. | Jan 30, 1978 | SESE |
| K772267 | QUADRAPLEGIC WALKING AID | Med Fusion Systems, Inc. | Dec 20, 1977 | SESE |
| K770529 | UNICET I | Union Carbide Corp. | Apr 5, 1977 | SESE |
Top Applicants
- Maddak, Inc. — 4 clearances
- Fred Sammons, Inc. — 1 clearance
- Guardian Products Co., Inc. — 1 clearance
- Manuco Manufacturing Co., Inc. — 1 clearance
- Med Fusion Systems, Inc. — 1 clearance
