Binder, Elastic
An Elastic Binder is a stretchable bandage or wrap used in general hospital and clinical care settings to provide support, compression, or immobilization to body areas such as the abdomen, chest, or extremities following injury, surgery, or for management of edema. It is classified as FDA Class 1, indicating low risk subject to general controls with no premarket submission requirement. The product code is KMO and it falls under 21 CFR 880.5160 in the General Hospital specialty. This device is GMP exempt.
Research product code KMO in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- KMO
- Device Class
- FDA class 1
- Regulation Number
- 880.5160
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K921852 | 4 SURE TM RECTAL TUBE | Oct 08, 1993 | Substantially Equivalent | Boston Pacific Medical, Inc. |
| K893809 | COUGH PILLOW | Aug 28, 1989 | Substantially Equivalent | Custom Hospitals Products |
| K883214 | THORACIC SUPPORT SYSTEM | Jan 17, 1989 | Substantially Equivalent | Storer Medical Products |
| K882592 | HEART HUGGER STERNUM SUPPORT HARNESS | Sep 20, 1988 | Substantially Equivalent | General Cardiac Technology, Inc. |
| K792629 | STERILIZATION PROCESS/T-BINDER | Jan 11, 1980 | Substantially Equivalent | Procter & Gamble Mfg. Co. |
FEI Numbers
This FDA classification entry is associated with 39 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 39 registration numbers. Click on an entry to view related FDA registrations.