FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PLS MINI
K Number: K792501
·
Decision Feb 26, 1980
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
2
Applicant Total
14
Review Days
84
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Basic Information
- Device Name
- PLS MINI
- K Number
- K792501
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5580
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Staodynamics, Inc.
- Date Received
- December 4, 1979
- Decision Date
- February 26, 1980
- Product Code
- BWJ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| BWJ | Locator, Acupuncture Point | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BWJ), ordered by most recent decision date.
POINT LOCATOR STIMULATOR
FDA 510(k)
FDA Class 2
·General Hospital
RYUSEI
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Staodynamics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K852298 | TENS-AID STERILE ELECTRODES FOR POST-OP TENS | Jun 24, 1985 | Substantially Equivalent |
| K843964 | TENS-AID PREMIUM ELECTRODES | Feb 25, 1985 | Substantially Equivalent |
| K832988 | STAODYN EMS/PLUS | Nov 22, 1983 | Substantially Equivalent |
| K813283 | 10D (TENS DEVICE) | Feb 10, 1982 | Substantially Equivalent |
| K813098 | TENS DEVICE | Nov 20, 1981 | Substantially Equivalent |
| K811345 | INSIGHT | Jul 10, 1981 | Substantially Equivalent |
| K792529 | POINT LOCATOR STIMULATOR | Feb 26, 1980 | Substantially Equivalent |
| K800068 | ELECTRICAL MUSCLE STIMULATOR (EMS) | Feb 5, 1980 | Substantially Equivalent |
| K792502 | TENS 4100 | Dec 18, 1979 | Substantially Equivalent |
| K792474 | TENS 4500 | Dec 13, 1979 | Substantially Equivalent |