Personal Knee Crutch Pad
FDA 510(k) K831149 · Tecnol New Jersey Wound Care, Inc.
510(k) numberK831149
Submission
- Device name
- Personal Knee Crutch Pad
- Applicant
- Tecnol New Jersey Wound Care, Inc.
Hammonton, NJ, US - Received
- April 8, 1983
- Decision date
- May 3, 1983
- 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 |
| 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 |
| K800076 | Crutch Tips, Pads & Hand GripsINP · Traditional | New World Imports, Inc. | 01/28/1980SE |
More from New World Imports, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K913043 | Modification Tecnol Fluidshield Surgical MasksFXX · Traditional | 08/23/1991SE |
| K911891 | Fluidshield(Tm) Cone Classic(Tm) II Surgical MaskFXX · Traditional | 07/12/1991SE |
| K911907 | Fluidshield Cone Classic II Surg Mask W/Splash VisFXX · Traditional | 07/08/1991SE |
| K896193 | Tecnol Lazer(Tm) Surgical MaskFXX · Traditional | 02/27/1990SE |
| K894205 | Tecnol Silk StripFPX · Traditional | 07/25/1989SE |
| K893702 | Tecnol Gaiters Product Number 47725-010FXP · Traditional | 06/23/1989SE |
| K891187 | Tecnol Naso-Gastric Tube HolderBSS · Traditional | 05/30/1989SE |
| K891178 | Tecnol Secure-All Tube HolderEYZ · Traditional | 05/23/1989SE |
| K884440 | Tecnol Variable Tension BandageNAD · Traditional | 01/17/1989SN |
| K882640 | Tecnol Secure-All Pelvic Traction BeltKQZ · Traditional | 07/27/1988SE |
Questions and answers
When was Personal Knee Crutch Pad cleared by the FDA?
Personal Knee Crutch Pad (K831149) received a 510(k) decision of Substantially Equivalent on May 3, 1983, 25 days after the submission was received.
What is the product code of K831149?
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.