Product Code: FQM
FDA class 1
21 CFR 880.5075
Bandage, Elastic
General Hospital
An elastic bandage is a stretchable fabric wrap used to apply compression or support to injured or post-operative body parts, aiding in the management of swelling, sprains, and wound care. It is classified as FDA Class 1 (lowest risk), subject only to general controls, with no premarket submission required. The product code is FQM, regulated under 21 CFR 880.5075, within the General Hospital medical specialty. This device is exempt from GMP requirements.
510(k)s
42
FEI Numbers
691
Registration Numbers
691
Unique Applicants
28
Years Active
28
Basic Information
- Product Code
- FQM
- Device Class
- FDA class 1
- Regulation Number
- 880.5075
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
✓
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 42 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K040936 | PETIT SILMA ELASTIC BANDAGE WITH GERMANIUM/TITANIUM OXIDE | May 03, 2004 | Substantially Equivalent | LEDA CO., LTD. |
| K040054 | BACK IN ACTION COMPRESSION & SUPPORT WITH MAGNETS FOR THE LOWER BACK, KNEE AND ANKLE | Apr 27, 2004 | Substantially Equivalent | THEODORE BARASH |
| K013244 | COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBE | Dec 07, 2001 | Substantially Equivalent | MED GEN, INC. |
| K952738 | SKIN SAVER SYSTEMS | Sep 29, 1995 | Substantially Equivalent | SKIN SAVER SYSTEMS, INC. |
| K872868 | ASPEN ESMARK BANDAGE | Jul 31, 1987 | Substantially Equivalent | ASPEN LABORATORIES, INC. |
| K840107 | TUBE-BANDAGE FOR HUMAN DIGITS 200 | Apr 25, 1984 | Substantially Equivalent | ZENS HEALTH CARE PRODUCTS |
| K831728 | MEDICALEX | Jan 09, 1984 | Substantially Equivalent | MEDICALEX |
| K830622 | ORTHO WRAP | Jun 20, 1983 | Substantially Equivalent | FAST WRAP CO., INC. |
| K831551 | COMPRESSOGRIP TUBULAR ELASTIC BANDAGE | Jun 07, 1983 | Substantially Equivalent | FRED SAMMONS, INC. |
| K820142 | TUBULAR STOCKINETTE | Feb 05, 1982 | Substantially Equivalent | STAN-PAK ENT. |
| K820141 | BIAS STOCKINETTE | Feb 05, 1982 | Substantially Equivalent | STAN-PAK ENT. |
| K820094 | ELASTIC BANDAGE | Jan 29, 1982 | Substantially Equivalent | STAN-PAK ENT. |
| K811173 | STRUVA & MEDI | Jun 18, 1981 | Substantially Equivalent | WECO |
| K810137 | SOF-BAND HIGH STRETCH BANDAGES | Feb 17, 1981 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K802992 | ELASTIC GAUZE | Dec 30, 1980 | Substantially Equivalent | ABCO DEALERS, INC. |
| K802991 | ROLL STRETCH GAUZE | Dec 30, 1980 | Substantially Equivalent | ABCO DEALERS, INC. |
| K802785 | ELASTIC BANDAGE | Dec 11, 1980 | Substantially Equivalent | SECOL CO. |
| K802789 | TUBULAR BANDAGE | Dec 10, 1980 | Substantially Equivalent | SECOL CO. |
| K802784 | ELASTIC OPEN WEAVE BANDAGE | Dec 10, 1980 | Substantially Equivalent | SECOL CO. |
| K802015 | FINGER PAINGUARD CAT.#193-194 | Sep 09, 1980 | Substantially Equivalent | POLLAK (INTL.), LTD. |
| K801990 | ELASTIC BANDAGE CAT.#182-186 (WIDTH) | Sep 09, 1980 | Substantially Equivalent | POLLAK (INTL.), LTD. |
| K801532 | STOCKINETTE, STERILE TWO PLY W/PULL TABS | Jul 28, 1980 | Substantially Equivalent | THE OWENBY CO. |
| K801458 | WINTER HEAD DRESSING | Jul 28, 1980 | Substantially Equivalent | STERIDYNE CORP. |
| K800280 | MEDSPEC RUBBER ELASTIC BANDAGES | Mar 12, 1980 | Substantially Equivalent | MEDSPEC CORP. |
| K800197 | ANAGO DISP., ALL PURPOSE PATIENT REST. | Feb 26, 1980 | Substantially Equivalent | ANAGO, INC. |
| K792331 | TOMMY TOES | Dec 20, 1979 | Substantially Equivalent | TOMMY TOES |
| K792065 | POROUS ELASTIC RUBBER BANDAGE | Nov 20, 1979 | Substantially Equivalent | NORMAN R. SANBORN CO. |
| K791256 | SECUTEX SURGICAL BINDER | Aug 03, 1979 | Substantially Equivalent | CONPHAR, INC. |
| K791211 | BINDAFIX | Aug 03, 1979 | Substantially Equivalent | CONPHAR, INC. |
| K790210 | STOCKINETTE, TUBULAR UNBLEACHED | Feb 27, 1979 | Substantially Equivalent | THE OWENBY CO. |
| K781931 | TAPE, ELASTOPLAST ELASTIC TEAR | Dec 07, 1978 | Substantially Equivalent | BEIERSDORF, INC. |
| K780606 | BANDAGE | Apr 19, 1978 | Substantially Equivalent | ABCO DEALERS, INC. |
| K780570 | TUBULAR DRESSING RETAINER | Apr 19, 1978 | Substantially Equivalent | ALBA-WALDENSIAN, INC. |
| K780231 | BANDAGE, ELASTIC | Feb 21, 1978 | Substantially Equivalent | BIOMET, INC. |
| K771758 | ELASTOMULL GAUZE BANDAGE | Oct 13, 1977 | Substantially Equivalent | BEIERSDORF, INC. |
| K771563 | CONFORM ELASTIC NETTING | Sep 12, 1977 | Substantially Equivalent | KENDALL RESEARCH CENTER |
| K770958 | BANDAGE, UNIPRESS, CLARION | Jun 14, 1977 | Substantially Equivalent | SHERWOOD MEDICAL INDUSTRIES |
| K760142 | BANDAGE, RAPIDO-LASTIC COTTON/NYLON | Jul 19, 1976 | Substantially Equivalent | CONCO MEDICAL CO. |
| K760141 | BANDAGE, CONFO-LASTIC ALL COTTON ELASTIC | Jul 19, 1976 | Substantially Equivalent | CONCO MEDICAL CO. |
| K760140 | BANDAGE, WRINKY-LASTIC ELASTIC GAUZE | Jul 19, 1976 | Substantially Equivalent | CONCO MEDICAL CO. |
| K760139 | BANDAGE, E-COTTON ELASTIC | Jul 19, 1976 | Substantially Equivalent | CONCO MEDICAL CO. |
| K760138 | BANDAGE, CEB COTTON ELASTIC | Jul 19, 1976 | Substantially Equivalent | CONCO MEDICAL CO. |
FEI Numbers
This FDA classification entry is associated with 691 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 691 registration numbers. Click on an entry to view related FDA registrations.