Product code ILI
- Device name
- Sling, Arm
- Medical specialty
- Physical Medicine
- Device class
- 1
- Regulation number
- 890.3640
- Review panel
- PM
- 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 |
|---|---|---|---|
| K912661 | MATRX, PYRAMID TRIANGLE BANDAGE | Matrix Medica, Inc. | 1991-08-21 |
| K831549 | ARM SLINGS | Fred Sammons, Inc. | 1983-06-30 |
| K831706 | SATO FAMILY FIRST AID KIT | Food and Drug Service, Inc. | 1983-06-24 |
| K823810 | A.C. SPLINT | Danek Medical, Inc. | 1983-01-14 |
| K823808 | VARIOUS ARM SLING | Danek Medical, Inc. | 1983-01-14 |
| K823664 | UNIVERSAL SLING, SLING & SWATHE | Warm & Form, Orthopedic Materials | 1982-12-30 |
| K823162 | UNIVERSAL SLING, SLING & SWATHE | Warm & Form, Orthopedic Materials | 1982-11-10 |
| K820590 | ORTHOPEDIC SOFT GOODS | Abco Dealers, Inc. | 1982-03-26 |
| K812477 | ARM SLING, POUCH TYPE | Maddak, Inc. | 1981-09-14 |
| K812480 | LIMB HOLDER ARM SLING | Maddak, Inc. | 1981-09-14 |
| K812478 | MADDACOMFORT SLING | Maddak, Inc. | 1981-09-14 |
| K812345 | ARM SLINGS | Fred Sammons, Inc. | 1981-09-11 |
| K803212 | BAUER & BLACK ARM SLING W/DETACH. POUCH | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-01-08 |
| K803139 | CONPHAR ARM SLINGS | Conphar, Inc. | 1981-01-08 |
| K802006 | TRIANGULAR BANDAGE CAT.#191 | Pollak (Intl.), Ltd. | 1980-09-16 |
| K801713 | BK-6157-02 C.V.A SLING, MEDIUM&LARGE | Fred Sammons, Inc. | 1980-08-07 |
| K801626 | ARM SLING | The Owenby Co. | 1980-07-28 |
| K801531 | ARM SLING | The Owenby Co. | 1980-07-21 |
| K771031 | STROKE SLING | Stat Medical Corp. | 1977-06-27 |
| K760574 | ECONOMY IMMOBILIZATION AND VELPEAN SLING | Richard'S Medical Equip., Inc. | 1976-10-06 |
| K760250 | BANDAGE, TRIANGULAR NO. 8068 | Johnson & Johnson Professionals, Inc. | 1976-07-26 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| M68932600100 | Cravat | Safeguard US Operating, LLC | 2024-10-09 |
| 00057475611026 | BIOS Living | Thermor Ltd | 2024-05-23 |
| 00609271020719 | CRADLE SLING ECONOMY | DARCO INTERNATIONAL, INC. | 2023-02-08 |
| 00609271020733 | CRADLE SLING ECONOMY | DARCO INTERNATIONAL, INC. | 2023-02-08 |
| 00609271020757 | CRADLE SLING ECONOMY | DARCO INTERNATIONAL, INC. | 2023-02-08 |
| 00609271020771 | CRADLE SLING ECONOMY | DARCO INTERNATIONAL, INC. | 2023-02-08 |
| 00609271020788 | CRADLE SLING ECONOMY | DARCO INTERNATIONAL, INC. | 2023-02-08 |
| 00610570174560 | ENVELOPE STYLE ARM SLING 2XL | Bird & Cronin, LLC | 2022-08-30 |
| 00610570174584 | UNIV ARM SLING W/FOAM STRAP ADULT | Bird & Cronin, LLC | 2022-08-30 |
| 00616784367217 | Triangular Bandages | Dynarex Corporation | 2021-09-01 |
| 00616784368016 | Triangular Bandages | Dynarex Corporation | 2021-09-01 |
| 00616784368115 | Triangular Bandages | Dynarex Corporation | 2021-09-01 |
| 00616784434728 | Arm Sling | Dynarex Corporation | 2021-09-01 |
| 00616784434827 | Arm Sling | Dynarex Corporation | 2021-09-01 |
| 00616784434926 | Arm Sling | Dynarex Corporation | 2021-09-01 |
| 00616784435022 | Arm Sling | Dynarex Corporation | 2021-09-01 |
| 10840200305720 | E.M Adams co, inc. | E.M. ADAMS, INC. | 2021-05-21 |
| 10840200305805 | E.M Adams co, inc. | E.M. ADAMS, INC. | 2021-05-21 |
| 10840200305782 | E.M Adams co, inc. | E.M. ADAMS, INC. | 2021-05-21 |
| 10840200305768 | E.M Adams co, inc. | E.M. ADAMS, INC. | 2021-05-21 |
| 10840200305744 | E.M Adams co, inc. | E.M. ADAMS, INC. | 2021-05-21 |
| 00049022754959 | Well at Walgreens | WALGREEN CO. | 2020-05-29 |
| 18100013405805 | E.M Adams co, inc. | E.M. ADAMS, INC. | 2019-12-31 |
| 18100013405782 | E.M Adams co, inc. | E.M. ADAMS, INC. | 2019-12-31 |
| 18100013405768 | E.M Adams co, inc. | E.M. ADAMS, INC. | 2019-12-31 |
| 18100013405744 | E.M Adams co, inc. | E.M. ADAMS, INC. | 2019-12-31 |
| 18100013405720 | E.M Adams co, inc. | E.M. ADAMS, INC. | 2019-12-31 |
| 00347682650100 | Medi-First Triangular Bandage | Medique Products | 2019-07-12 |
| 50050428585394 | DRIVEMEDICAL | Drive Devilbiss Healthcare | 2019-06-21 |
| 10686864048845 | MEDICOM SAFEBASICS | AMD Medicom Inc | 2019-01-16 |