KNP · Orthosis, Corrective Shoe
Physical Medicine · 21 CFR 890.3475 · Class 1
Overview
| Product Code | KNP |
|---|---|
| Device Name | Orthosis, Corrective Shoe |
| Regulation | 21 CFR 890.3475 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
| GMP Exempt | Yes |
Identification
A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement. Examples of limb orthoses include the following: A whole limb and joint brace, a hand splint, an elastic stocking, a knee cage, and a corrective shoe.
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 (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K831690 | IPOS ANTI-ADDUCTUS SHOE | Ipos Luneburg | Jun 24, 1983 | SESE |
| K831552 | SORBOTHANE VISCO INNER SOLE PAD | Fred Sammons, Inc. | Jun 8, 1983 | SESE |
| K823654 | SLIP-ON SANDALS FOR MEASURING SHORTNESS | Fred Sammons, Inc. | Jan 21, 1983 | SESE |
| K823665 | ROTATION BOOT | Warm & Form, Orthopedic Materials | Dec 30, 1982 | SESE |
| K810228 | SORBOTHANE | Hamilton Kent | Feb 10, 1981 | SESE |
| K801743 | PLASTAZOTE SHOE | Alimed, Inc. | Aug 7, 1980 | SESE |
| K790326 | DRUSHOE | J.E. Hanger & Co. , Ltd. | Feb 26, 1979 | SESE |
Top Applicants
- Fred Sammons, Inc. — 2 clearances
- Alimed, Inc. — 1 clearance
- Hamilton Kent — 1 clearance
- Ipos Luneburg — 1 clearance
- J.E. Hanger & Co. , Ltd. — 1 clearance
