FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DEMI-WALKER (REGULAR)
K Number: K772268
·
Decision Dec 20, 1977
Classifications
1
FEI Numbers
442
Registration Numbers
442
Same Product Code
14
Applicant Total
22
Review Days
11
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Basic Information
- Device Name
- DEMI-WALKER (REGULAR)
- K Number
- K772268
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3475
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Med Fusion Systems, Inc.
- Date Received
- December 9, 1977
- Decision Date
- December 20, 1977
- Product Code
- ITQ
- 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 |
|---|---|---|---|
| ITQ | Joint, Knee, External Brace | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ITQ), ordered by most recent decision date.
LIMITED MOTION FUNCTIONAL KNEE BRACE
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BRACE C.T.
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DELUXE KNEE IMMOBILIZER(UNIVERSAL)
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FDA Class 1
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ANATOMIC FRACTURE BRACE
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FDA Class 1
·Physical Medicine
DELUXE KNEE IMMOBILIZER
FDA 510(k)
FDA Class 1
·Physical Medicine
NEOPRENE KNEE SUPPORT
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 |