Crutch Tips, Pads & Hand Grips
FDA 510(k) K800076 · New World Imports, Inc.
510(k) numberK800076
Submission
- Device name
- Crutch Tips, Pads & Hand Grips
- Applicant
- New World Imports, Inc.
Mchenry, IL, US - Received
- January 14, 1980
- Decision date
- January 28, 1980
- 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 |
| K811493 | Crutch & Walker PadsINP · Traditional | Fred Sammons, Inc. | 06/12/1981SE |
| 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 |
Questions and answers
When was Crutch Tips, Pads & Hand Grips cleared by the FDA?
Crutch Tips, Pads & Hand Grips (K800076) received a 510(k) decision of Substantially Equivalent on January 28, 1980, 14 days after the submission was received.
What is the product code of K800076?
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.