FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
QUADRAPLEGIC WALKING AID
K Number: K772267
·
Decision Dec 20, 1977
Classifications
1
FEI Numbers
169
Registration Numbers
169
Same Product Code
8
Applicant Total
22
Review Days
11
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Basic Information
- Device Name
- QUADRAPLEGIC WALKING AID
- K Number
- K772267
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3075
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Med Fusion Systems, Inc.
- Date Received
- December 9, 1977
- Decision Date
- December 20, 1977
- Product Code
- IPS
- 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 |
|---|---|---|---|
| IPS | Cane | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IPS), ordered by most recent decision date.
WALKING CANE
FDA 510(k)
FDA Class 1
·Physical Medicine
CANE REACHER
FDA 510(k)
FDA Class 1
·Physical Medicine
LIGHT WEIGHT ALUMINUM CANES
FDA 510(k)
FDA Class 1
·Physical Medicine
OFFSET ALUMINUM CANE
FDA 510(k)
FDA Class 1
·Physical Medicine
CERSA-CANE
FDA 510(k)
FDA Class 1
·Physical Medicine
FOREARM-CANE
FDA 510(k)
FDA Class 1
·Physical Medicine
Other Clearances by Med Fusion Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K873961 | INFUMED 300 AMBULATORY INFUSION PUMP | Dec 29, 1987 | Substantially Equivalent |
| K870524 | AMBULATORY INFUSION PUMP DRUG RESERVOIR | May 6, 1987 | Substantially Equivalent |
| K870907 | INTRODUCER, PERCUTANEOUS | Apr 9, 1987 | Substantially Equivalent |
| K864407 | REFILLABLE SYRINGE | Jan 20, 1987 | Substantially Equivalent |
| K863814 | BAG SPIKE EXTENSION SET | Oct 14, 1986 | Substantially Equivalent |
| K860616 | VOLUME CONTROL SET WITH EXTENSION | Jun 2, 1986 | Substantially Equivalent |
| K860803 | IV FILTER EXTENSION SET | Apr 9, 1986 | Substantially Equivalent |
| K844313 | INFUSET W/HUBER NEEDLE | Jan 22, 1985 | Substantially Equivalent |
| K842984 | EXTENSION SET W/INJECTION SITE | Oct 16, 1984 | Substantially Equivalent |
| K842143 | BENT WINGED MINI-VOL INFUSION SET | Jul 20, 1984 | Substantially Equivalent |