Sling, Arm
FDA product code ILI · Class I (low risk) · 21 CFR 890.3640 · Physical Medicine
21510(k) clearances
0PMA approvals
5recalls
GMP exemptexempt from GMP rules
Manufacturers
- Fred Sammons, Inc. 3
- Maddak, Inc. 3
- The Owenby Co. 2
- Warm & Form, Orthopedic Materials 2
- Danek Medical, Inc. 2
- Johnson & Johnson Professionals, Inc. 1
- Richard'S Medical Equip., Inc. 1
- Stat Medical Corp. 1
- Pollak (Intl.), Ltd. 1
- Conphar, Inc. 1
- Bd Becton Dickinson Vacutainer Systems Preanalytic 1
- Abco Dealers, Inc. 1
- Food and Drug Service, Inc. 1
- Matrix Medica, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K912661 | Matrx, Pyramid Triangle BandageILI · Traditional | Matrix Medica, Inc. | 08/21/1991SE |
| K831549 | Arm SlingsILI · Traditional | Fred Sammons, Inc. | 06/30/1983SE |
| K831706 | Sato Family First Aid KitILI · Traditional | Food and Drug Service, Inc. | 06/24/1983SE |
| K823810 | A.C. SplintILI · Traditional | Danek Medical, Inc. | 01/14/1983SE |
| K823808 | Various Arm SlingILI · Traditional | Danek Medical, Inc. | 01/14/1983SE |
| K823664 | Universal Sling, Sling & SwatheILI · Traditional | Warm & Form, Orthopedic Materials | 12/30/1982SE |
| K823162 | Universal Sling, Sling & SwatheILI · Traditional | Warm & Form, Orthopedic Materials | 11/10/1982SE |
| K820590 | Orthopedic Soft GoodsILI · Traditional | Abco Dealers, Inc. | 03/26/1982SE |
| K812480 | Limb Holder Arm SlingILI · Traditional | Maddak, Inc. | 09/14/1981SE |
| K812478 | Maddacomfort SlingILI · Traditional | Maddak, Inc. | 09/14/1981SE |
| K812477 | Arm Sling, Pouch TypeILI · Traditional | Maddak, Inc. | 09/14/1981SE |
| K812345 | Arm SlingsILI · Traditional | Fred Sammons, Inc. | 09/11/1981SE |
| K803212 | Bauer & Black Arm Sling W/Detach. PouchILI · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 01/08/1981SE |
| K803139 | Conphar Arm SlingsILI · Traditional | Conphar, Inc. | 01/08/1981SE |
| K802006 | Triangular Bandage CAT.#191ILI · Traditional | Pollak (Intl.), Ltd. | 09/16/1980SE |
| K801713 | BK-6157-02 C.V.A Sling, Medium&LargeILI · Traditional | Fred Sammons, Inc. | 08/07/1980SE |
| K801626 | Arm SlingILI · Traditional | The Owenby Co. | 07/28/1980SE |
| K801531 | Arm SlingILI · Traditional | The Owenby Co. | 07/21/1980SE |
| K771031 | Stroke SlingILI · Traditional | Stat Medical Corp. | 06/27/1977SE |
| K760574 | Economy Immobilization and Velpean SlingILI · Traditional | Richard'S Medical Equip., Inc. | 10/06/1976SE |
| K760250 | Bandage, Triangular No. 8068ILI · Traditional | Johnson & Johnson Professionals, Inc. | 07/26/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1514-2021 Class II | DONJOY REF:11-0473-9 ULTRASLING PRO AB, UNIVERSAL, Rx ONLY, UDI: (01)00190446683681 -…failed rivet at the chafe tab of arm sling. | DJ Orthopedics de Mexico S.A. de C.V. | 04/12/2021Terminated |
| Z-1513-2021 Class II | DONJOY REF:11-0472-9 ULTRASLING PRO ER/IR 30, UNIVERSAL, Rx ONLY, UDI:…failed rivet at the chafe tab of arm sling. | DJ Orthopedics de Mexico S.A. de C.V. | 04/12/2021Terminated |
| Z-1512-2021 Class II | DONJOY REF:11-0471-9 ULTRASLING PRO ER/IR 15, UNIVERSAL, Rx ONLY, UDI: (01)…failed rivet at the chafe tab of arm sling. | DJ Orthopedics de Mexico S.A. de C.V. | 04/12/2021Terminated |
| Z-1511-2021 Class II | DONJOY REF:11-0447-9-ULTRASLING PRO, UNIVERSAL, Rx ONLY, UDI:(01)00190446673552 -…failed rivet at the chafe tab of arm sling. | DJ Orthopedics de Mexico S.A. de C.V. | 04/12/2021Terminated |
| Z-0888-2017 Class II | Medi Choice Arm Slings ASL 2103 Small 7.5 x 12.5 Inch 1/EA, 24 ENCA ASL 2104 Medium 8 x…Owens & Minor is the initial importer and private label distributor of Medi Choice Arm Slings (Product). The… | Owens & Minor Distribution, Inc. | 10/31/2016Terminated |