FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDICAL DESIGNS, INC. BIO-THERAPY SYSTEM
K Number: K911911
·
Decision Mar 20, 1992
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
171
Applicant Total
10
Review Days
325
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Basic Information
- Device Name
- MEDICAL DESIGNS, INC. BIO-THERAPY SYSTEM
- K Number
- K911911
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5050
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medical Design & Manufacturing Corp.
- Date Received
- April 30, 1991
- Decision Date
- March 20, 1992
- Product Code
- HCC
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| HCC | Device, Biofeedback | FDA class 2 | Neurology |
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|---|---|---|---|
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| 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 |
| K810222 | LIMB ORHTOSIS | Feb 4, 1981 | Substantially Equivalent |