FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LIMB ORHTOSIS
K Number: K810222
·
Decision Feb 4, 1981
Classifications
1
FEI Numbers
442
Registration Numbers
442
Same Product Code
14
Applicant Total
10
Review Days
8
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Basic Information
- Device Name
- LIMB ORHTOSIS
- K Number
- K810222
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3475
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Medical Design & Manufacturing Corp.
- Date Received
- January 27, 1981
- Decision Date
- February 4, 1981
- 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 Medical Design & Manufacturing Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K911911 | MEDICAL DESIGNS, INC. BIO-THERAPY SYSTEM | Mar 20, 1992 | Substantially Equivalent |
| K914384 | MEDICAL DESIGNS REUSABLE CARBON RUBBER ELECTRODE | Nov 13, 1991 | Substantially Equivalent |
| K911366 | PROTECTOR DISPOSABLE TENS AND NMES ELECTRODE | Sep 27, 1991 | Substantially Equivalent |
| K902822 | MEDICAL DESIGNS, INC., SPECTRUM II TENS DEVICE | Dec 19, 1990 | Substantially Equivalent |
| K895604 | SOFT-EZ REUSABLE SELF-ADHERING PIGTAIL ELECTRODES | Oct 13, 1989 | Substantially Equivalent |
| K880492 | INTERCEPT T.E.N.S. DEVICE | Apr 18, 1988 | Substantially Equivalent |
| K834138 | HYPO SUTURE | Jan 27, 1984 | Substantially Equivalent |
| K821848 | ASSURE-MALE EXTERNAL INCONTINCE CATHETER | Aug 10, 1982 | Substantially Equivalent |
| K811224 | MINISTIM | Jun 2, 1981 | Substantially Equivalent |