FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELECTRO-TOUCH (ET) GLOVE
K Number: K890981
·
Decision Oct 19, 1989
Classifications
1
FEI Numbers
243
Registration Numbers
243
Same Product Code
436
Applicant Total
2
Review Days
234
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Basic Information
- Device Name
- ELECTRO-TOUCH (ET) GLOVE
- K Number
- K890981
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1320
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Psychoenergetic Systems, Inc.
- Date Received
- February 27, 1989
- Decision Date
- October 19, 1989
- Product Code
- GXY
- 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 |
|---|---|---|---|
| GXY | Electrode, Cutaneous | FDA class 2 | Neurology |
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Other Clearances by Psychoenergetic Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K910801 | HIGH VOLTAGE PULSED GALVANIC STIMULATION APPLICATI | Sep 4, 1991 | Substantially Equivalent |