FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PERSONAL KNEE CRUTCH PAD
K Number: K831149
·
Decision May 3, 1983
Classifications
1
FEI Numbers
144
Registration Numbers
144
Same Product Code
7
Applicant Total
35
Review Days
25
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PERSONAL KNEE CRUTCH PAD
- K Number
- K831149
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3790
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Tecnol New Jersey Wound Care, Inc.
- Date Received
- April 8, 1983
- Decision Date
- May 3, 1983
- Product Code
- INP
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| INP | Tips And Pads, Cane, Crutch And Walker | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (INP), ordered by most recent decision date.
SURGEON'S CHOICE CRUTCH HANDLE
FDA 510(k)
FDA Class 1
·Physical Medicine
CRUTCH & WALKER PADS
FDA 510(k)
FDA Class 1
·Physical Medicine
CRUTCH TIPS & GRIPS
FDA 510(k)
FDA Class 1
·Physical Medicine
CONPHAR CRUTCH PADS
FDA 510(k)
FDA Class 1
·Physical Medicine
CONPHAR CRUTCH TIPS
FDA 510(k)
FDA Class 1
·Physical Medicine
CONPHAR CRUTCH GRIPS
FDA 510(k)
FDA Class 1
·Physical Medicine
Other Clearances by Tecnol New Jersey Wound Care, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K913043 | MODIFICATION TECNOL FLUIDSHIELD SURGICAL MASKS | Aug 23, 1991 | Substantially Equivalent |
| K911891 | FLUIDSHIELD(TM) CONE CLASSIC(TM) II SURGICAL MASK | Jul 12, 1991 | Substantially Equivalent |
| K911907 | FLUIDSHIELD CONE CLASSIC II SURG MASK W/SPLASH VIS | Jul 8, 1991 | Substantially Equivalent |
| K896193 | TECNOL LAZER(TM) SURGICAL MASK | Feb 27, 1990 | Substantially Equivalent |
| K894205 | TECNOL SILK STRIP | Jul 25, 1989 | Substantially Equivalent |
| K893702 | TECNOL GAITERS PRODUCT NUMBER 47725-010 | Jun 23, 1989 | Substantially Equivalent |
| K891187 | TECNOL NASO-GASTRIC TUBE HOLDER | May 30, 1989 | Substantially Equivalent |
| K891178 | TECNOL SECURE-ALL TUBE HOLDER | May 23, 1989 | Substantially Equivalent |
| K884440 | TECNOL VARIABLE TENSION BANDAGE | Jan 17, 1989 | Substantially Equivalent for Some Indications |
| K882640 | TECNOL SECURE-ALL PELVIC TRACTION BELT | Jul 27, 1988 | Substantially Equivalent |