Crutch & Walker Pads
FDA 510(k) K811493 · Fred Sammons, Inc.
510(k) numberK811493
Submission
- Device name
- Crutch & Walker Pads
- Applicant
- Fred Sammons, Inc.
Mchenry, IL, US - Received
- May 26, 1981
- Decision date
- June 12, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- INP – Tips And Pads, Cane, Crutch And Walker
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3790
- Specialty
- Physical Medicine
Other 510(k)s with product code INP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K831889 | Surgeon's Choice Crutch HandleINP · Traditional | W.K. Wheeler, Inc. | 07/07/1983SE |
| K831149 | Personal Knee Crutch PadINP · Traditional | Tecnol New Jersey Wound Care, Inc. | 05/03/1983SE |
| K810650 | Crutch Tips & GripsINP · Traditional | First Industries, Inc. | 03/26/1981SE |
| K803144 | Conphar Crutch PadsINP · Traditional | Conphar, Inc. | 01/08/1981SE |
| K803140 | Conphar Crutch GripsINP · Traditional | Conphar, Inc. | 01/08/1981SE |
| K803136 | Conphar Crutch TipsINP · Traditional | Conphar, Inc. | 01/08/1981SE |
| K800076 | Crutch Tips, Pads & Hand GripsINP · Traditional | New World Imports, Inc. | 01/28/1980SE |
More from New World Imports, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K880644 | Ultra-Pan for Orthotic Plastics (7262)IRQ · Traditional | 05/06/1988SE |
| K880647 | Adult Perceptual Motor Puzzles (5331-01)HOX · Traditional | 04/01/1988SE |
| K831549 | Arm SlingsILI · Traditional | 06/30/1983SE |
| K831548 | SplintsILH · Traditional | 06/27/1983SE |
| K831550 | Finger Boniometer BK7506KQW · Traditional | 06/24/1983SE |
| K831544 | Deluxe Traction Exercise Glove BK5035IOD · Traditional | 06/24/1983SE |
| K831543 | Adjust. WEIGHTS-BK5171-05,10,20 BeokION · Traditional | 06/24/1983SE |
| K831542 | Adjustable Polycentric Elbow HingeIQI · Traditional | 06/24/1983SE |
| K831553 | Leg Drainage Bag Strap BK6011KNX · Traditional | 06/16/1983SE |
| K831552 | Sorbothane Visco Inner Sole PadKNP · Traditional | 06/08/1983SE |
Questions and answers
When was Crutch & Walker Pads cleared by the FDA?
Crutch & Walker Pads (K811493) received a 510(k) decision of Substantially Equivalent on June 12, 1981, 17 days after the submission was received.
What is the product code of K811493?
The FDA product code is INP – Tips And Pads, Cane, Crutch And Walker, a Class I (low risk) device regulated under 21 CFR 890.3790.