Product code KMO
- Device name
- Binder, Elastic
- Medical specialty
- General Hospital
- Device class
- 1
- Regulation number
- 880.5160
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K921852 | 4 SURE TM RECTAL TUBE | Boston Pacific Medical, Inc. | 1993-10-08 |
| K893809 | COUGH PILLOW | Custom Hospitals Products | 1989-08-28 |
| K883214 | THORACIC SUPPORT SYSTEM | Storer Medical Products | 1989-01-17 |
| K882592 | HEART HUGGER STERNUM SUPPORT HARNESS | General Cardiac Technology, Inc. | 1988-09-20 |
| K792629 | STERILIZATION PROCESS/T-BINDER | Procter & Gamble Mfg. Co. | 1980-01-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00745129333881 | Chipsleeve Arm No Hand LG Reg RT | SIGVARIS INC | 2026-01-09 |
| 00745129334024 | Chipsleeve Arm No Hand XXL Short RT | SIGVARIS INC | 2026-01-09 |
| 00745129334017 | Chipsleeve Arm No Hand XXL Short LT | SIGVARIS INC | 2026-01-09 |
| 00745129334000 | Chipsleeve Arm No Hand XXL Reg RT | SIGVARIS INC | 2026-01-09 |
| 00745129333997 | Chipsleeve Arm No Hand XXL Reg LT | SIGVARIS INC | 2026-01-09 |
| 00745129333980 | Chipsleeve Arm No Hand XXL Long RT | SIGVARIS INC | 2026-01-09 |
| 00745129333973 | Chipsleeve Arm No Hand XXL Long LT | SIGVARIS INC | 2026-01-09 |
| 00745129333966 | Chipsleeve Arm No Hand XL Short RT | SIGVARIS INC | 2026-01-09 |
| 00745129333959 | Chipsleeve Arm No Hand XL Short LT | SIGVARIS INC | 2026-01-09 |
| 00745129333942 | Chipsleeve Arm No Hand XL Reg RT | SIGVARIS INC | 2026-01-09 |
| 00745129333935 | Chipsleeve Arm No Hand XL Reg LT | SIGVARIS INC | 2026-01-09 |
| 00745129333928 | Chipsleeve Arm No Hand XL Long RT | SIGVARIS INC | 2026-01-09 |
| 00745129333911 | Chipsleeve Arm No Hand XL Long LT | SIGVARIS INC | 2026-01-09 |
| 00745129333904 | Chipsleeve Arm No Hand LG Short RT | SIGVARIS INC | 2026-01-09 |
| 00745129333898 | Chipsleeve Arm No Hand LG Short LT | SIGVARIS INC | 2026-01-09 |
| 00745129333737 | Chipsleeve Arm No Hand SM Long LT | SIGVARIS INC | 2026-01-09 |
| 00745129333874 | Chipsleeve Arm No Hand LG Reg LT | SIGVARIS INC | 2026-01-09 |
| 00745129333867 | Chipsleeve Arm No Hand LG Long RT | SIGVARIS INC | 2026-01-09 |
| 00745129333850 | Chipsleeve Arm No Hand LG Long LT | SIGVARIS INC | 2026-01-09 |
| 00745129333843 | Chipsleeve Arm No Hand MD Short RT | SIGVARIS INC | 2026-01-09 |
| 00745129333836 | Chipsleeve Arm No Hand MD Short LT | SIGVARIS INC | 2026-01-09 |
| 00745129333829 | Chipsleeve Arm No Hand MD Reg RT | SIGVARIS INC | 2026-01-09 |
| 00745129333812 | Chipsleeve Arm No Hand MD Reg LT | SIGVARIS INC | 2026-01-09 |
| 00745129333805 | Chipsleeve Arm No Hand MD Long RT | SIGVARIS INC | 2026-01-09 |
| 00745129333799 | Chipsleeve Arm No Hand MD Long LT | SIGVARIS INC | 2026-01-09 |
| 00745129333782 | Chipsleeve Arm No Hand SM Short RT | SIGVARIS INC | 2026-01-09 |
| 00745129333775 | Chipsleeve Arm No Hand SM Short LT | SIGVARIS INC | 2026-01-09 |
| 00745129333768 | Chipsleeve Arm No Hand SM Reg RT | SIGVARIS INC | 2026-01-09 |
| 00745129333751 | Chipsleeve Arm No Hand SM Reg LT | SIGVARIS INC | 2026-01-09 |
| 00745129333744 | Chipsleeve Arm No Hand SM Long RT | SIGVARIS INC | 2026-01-09 |