ILI · Sling, Arm
Physical Medicine · 21 CFR 890.3640 · Class 1
Overview
| Product Code | ILI |
|---|---|
| Device Name | Sling, Arm |
| Regulation | 21 CFR 890.3640 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
| GMP Exempt | Yes |
Identification
An arm sling is a device intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (20 of 21)
Showing 20 most recent of 21 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K912661 | MATRX, PYRAMID TRIANGLE BANDAGE | Matrix Medica, Inc. | Aug 21, 1991 | SESE |
| K831549 | ARM SLINGS | Fred Sammons, Inc. | Jun 30, 1983 | SESE |
| K831706 | SATO FAMILY FIRST AID KIT | Food and Drug Service, Inc. | Jun 24, 1983 | SESE |
| K823810 | A.C. SPLINT | Danek Medical, Inc. | Jan 14, 1983 | SESE |
| K823808 | VARIOUS ARM SLING | Danek Medical, Inc. | Jan 14, 1983 | SESE |
| K823664 | UNIVERSAL SLING, SLING & SWATHE | Warm & Form, Orthopedic Materials | Dec 30, 1982 | SESE |
| K823162 | UNIVERSAL SLING, SLING & SWATHE | Warm & Form, Orthopedic Materials | Nov 10, 1982 | SESE |
| K820590 | ORTHOPEDIC SOFT GOODS | Abco Dealers, Inc. | Mar 26, 1982 | SESE |
| K812480 | LIMB HOLDER ARM SLING | Maddak, Inc. | Sep 14, 1981 | SESE |
| K812478 | MADDACOMFORT SLING | Maddak, Inc. | Sep 14, 1981 | SESE |
| K812477 | ARM SLING, POUCH TYPE | Maddak, Inc. | Sep 14, 1981 | SESE |
| K812345 | ARM SLINGS | Fred Sammons, Inc. | Sep 11, 1981 | SESE |
| K803212 | BAUER & BLACK ARM SLING W/DETACH. POUCH | Bd Becton Dickinson Vacutainer Systems Preanalytic | Jan 8, 1981 | SESE |
| K803139 | CONPHAR ARM SLINGS | Conphar, Inc. | Jan 8, 1981 | SESE |
| K802006 | TRIANGULAR BANDAGE CAT.#191 | Pollak (Intl.), Ltd. | Sep 16, 1980 | SESE |
| K801713 | BK-6157-02 C.V.A SLING, MEDIUM&LARGE | Fred Sammons, Inc. | Aug 7, 1980 | SESE |
| K801626 | ARM SLING | The Owenby Co. | Jul 28, 1980 | SESE |
| K801531 | ARM SLING | The Owenby Co. | Jul 21, 1980 | SESE |
| K771031 | STROKE SLING | Stat Medical Corp. | Jun 27, 1977 | SESE |
| K760574 | ECONOMY IMMOBILIZATION AND VELPEAN SLING | Richard'S Medical Equip., Inc. | Oct 6, 1976 | SESE |
Top Applicants
- Fred Sammons, Inc. — 3 clearances
- Maddak, Inc. — 3 clearances
- Danek Medical, Inc. — 2 clearances
- The Owenby Co. — 2 clearances
- Warm & Form, Orthopedic Materials — 2 clearances
