LLK · Legging, Compression, Non-Inflatable
General Hospital · 21 CFR 880.5780 · Class 2
Overview
| Product Code | LLK |
|---|---|
| Device Name | Legging, Compression, Non-Inflatable |
| Regulation | 21 CFR 880.5780 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
Medical support stocking to prevent the pooling of blood in the legs: A medical support stocking to prevent the pooling of blood in the legs is a device that is constructed of elastic material and designed to apply controlled pressure to the leg and that is intended for use in the prevention of pooling of blood in the leg. Medical support stocking for general medical purposes: A medical support stocking for general medical purposes is a device that is constructed of elastic material and designed to apply controlled pressure to the leg and that is intended for medical purposes other than the prevention of pooling of blood in the leg.
Classification Rationale
For the medical support stocking to prevent the pooling of blood in the legs: Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9. For the medical support stocking for general medical purposes: Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. 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.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.(b) *Medical support stocking for general medical purposes* —(1)*Identification.* A medical support stocking for general medical purposes is a device that is constructed of elastic material and designed to apply controlled pressure to the leg and that is intended for medical purposes other than the prevention of pooling of blood in the leg.(2) *Classification.* Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. 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 (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K903532 | UNNA-SLEEVE(TM) | Aci Medical, Inc. | Nov 2, 1990 | SESE |
| K873368 | TECNOL COMPRESSION KNEE DRESSING | Tecnol New Jersey Wound Care, Inc. | Dec 11, 1987 | SESE |
| K871889 | COMPRESSION LEGGING DEVICE | A-T Surgical Mfg. Co., Inc. | Aug 4, 1987 | SESE |
| K834460 | MODEL 1888 ALPHA COS/RESPIRATION CAR | Spacelabs, Inc. | Feb 13, 1984 | SESE |
Top Applicants
- A-T Surgical Mfg. Co., Inc. — 1 clearance
- Aci Medical, Inc. — 1 clearance
- Spacelabs, Inc. — 1 clearance
- Tecnol New Jersey Wound Care, Inc. — 1 clearance
