FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MINISTIM
K Number: K811224
·
Decision Jun 2, 1981
Classifications
1
FEI Numbers
179
Registration Numbers
179
Same Product Code
601
Applicant Total
10
Review Days
29
Basic Information
- Device Name
- MINISTIM
- K Number
- K811224
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- MEDICAL DESIGN & MANUFACTURING CORP.
- Date Received
- May 4, 1981
- Decision Date
- June 2, 1981
- Product Code
- GZJ
- 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 |
|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | FDA class 2 | Neurology |
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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 |
| K810222 | LIMB ORHTOSIS | Feb 4, 1981 | Substantially Equivalent |