FQM · Bandage, Elastic
General Hospital · 21 CFR 880.5075 · Class 1
Overview
| Product Code | FQM |
|---|---|
| Device Name | Bandage, Elastic |
| Regulation | 21 CFR 880.5075 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
| GMP Exempt | Yes |
Identification
An elastic bandage is a device consisting of either a long flat strip or a tube of elasticized material that is used to support and compress a part of a patient's body.
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 § 880.9. The device also is 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 (20 of 42)
Showing 20 most recent of 42 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K040936 | PETIT SILMA ELASTIC BANDAGE WITH GERMANIUM/TITANIUM OXIDE | Leda Co., Ltd. | May 3, 2004 | SESE |
| K040054 | BACK IN ACTION COMPRESSION & SUPPORT WITH MAGNETS FOR THE LOWER BACK, KNEE AND ANKLE | Theodore Barash | Apr 27, 2004 | SESE |
| K013244 | COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBE | Med Gen, Inc. | Dec 7, 2001 | SESE |
| K952738 | SKIN SAVER SYSTEMS | Skin Saver Systems, Inc. | Sep 29, 1995 | SESE |
| K872868 | ASPEN ESMARK BANDAGE | Aspen Laboratories, Inc. | Jul 31, 1987 | SESE |
| K840107 | TUBE-BANDAGE FOR HUMAN DIGITS 200 | Zens Health Care Products | Apr 25, 1984 | SESE |
| K831728 | MEDICALEX | Medicalex | Jan 9, 1984 | SESE |
| K830622 | ORTHO WRAP | Fast Wrap Co., Inc. | Jun 20, 1983 | SESE |
| K831551 | COMPRESSOGRIP TUBULAR ELASTIC BANDAGE | Fred Sammons, Inc. | Jun 7, 1983 | SESE |
| K820142 | TUBULAR STOCKINETTE | Stan-Pak Ent. | Feb 5, 1982 | SESE |
| K820141 | BIAS STOCKINETTE | Stan-Pak Ent. | Feb 5, 1982 | SESE |
| K820094 | ELASTIC BANDAGE | Stan-Pak Ent. | Jan 29, 1982 | SESE |
| K811173 | STRUVA & MEDI | Weco | Jun 18, 1981 | SESE |
| K810137 | SOF-BAND HIGH STRETCH BANDAGES | Johnson & Johnson Professionals, Inc. | Feb 17, 1981 | SESE |
| K802992 | ELASTIC GAUZE | Abco Dealers, Inc. | Dec 30, 1980 | SESE |
| K802991 | ROLL STRETCH GAUZE | Abco Dealers, Inc. | Dec 30, 1980 | SESE |
| K802785 | ELASTIC BANDAGE | Secol Co. | Dec 11, 1980 | SESE |
| K802789 | TUBULAR BANDAGE | Secol Co. | Dec 10, 1980 | SESE |
| K802784 | ELASTIC OPEN WEAVE BANDAGE | Secol Co. | Dec 10, 1980 | SESE |
| K802015 | FINGER PAINGUARD CAT.#193-194 | Pollak (Intl.), Ltd. | Sep 9, 1980 | SESE |
Top Applicants
- Conco Medical Co. — 5 clearances
- Abco Dealers, Inc. — 3 clearances
- Secol Co. — 3 clearances
- Stan-Pak Ent. — 3 clearances
- Beiersdorf, Inc. — 2 clearances
