510(k) K831149
K831149 is an FDA 510(k) premarket notification submitted by Tecnol New Jersey Wound Care, Inc. for the device "PERSONAL KNEE CRUTCH PAD". The FDA issued a decision of Substantially Equivalent on May 3, 1983. The device falls under product code INP (Tips And Pads, Cane, Crutch And Walker), a Class I device regulated under 21 CFR 890.3790. Tecnol New Jersey Wound Care, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 3, 1983
- Date Received
- April 8, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tips And Pads, Cane, Crutch And Walker
- Device Class
- Class I
- Regulation Number
- 890.3790
- Review Panel
- PM
- Submission Type