Device Classification Name: Stimulator, Nerve, Transcutaneous, for Pain Relief
510(k) Number: K896948
Regulation Number: 882.5890
Device Name: ALPHA-STIM CS
Applicant: ELECTROMEDICAL PRODUCTS, INC.
Contact: L Kirsch
Classification Product Code: GZJ
Date Received: 12/13/1989
Decision Date: 02/23/1990
Decision: Substantially equivalent (SE)
Classification Advisory Committee: Neurology
Review Advisory Committee: Neurology
Statements/Summary/Purged Status: Purged, no summary or statement
Type: Traditional
Reviewed by Third Party: No
Product Classification
| Device | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Regulation Description | Transcutaneous Electrical Nerve Stimulator for Pain Relief. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| Product Code | GZJ |
| Submission Type | 510(k) |
| Regulation Number | 882.5890 |
| Device Class | 2 |
| GMP Exempt? | No |
Establishment Registration Database
Establishment:
ELECTROMEDICAL PRODUCTS INTL., INC.
2201 Garrett Morris Pkwy.
Mineral Wells, TX 76067-9034
Registration Number: 2020648
Operations: Initial Distributor, Specification Developer
Status: Active
Date of Registration Status: 2006Owner/Operator:
ELECTROMEDICAL PRODUCTS INTL., INC.
2201 Garrett Morris Pkwy.
Mineral Wells, TX 76067-9034
Owner/Operator Number:
9027065
Official Correspondent:
Ms. Tracey Kirsch
ELECTROMEDICAL PRODUCTS INTL., INC.
2201 Garrett Morris Pkwy.
Mineral Wells, TX 76067-9034
Phone: 940-328-0788 104
Code of Federal Regulations 5890
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2005]
[CITE: 21CFR882.5890]
TITLE 21–FOOD AND DRUGS
CHAPTER I–FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H–MEDICAL DEVICES
PART 882 — NEUROLOGICAL DEVICES
Subpart F–Neurological Therapeutic Devices
Sec. 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a) Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient’s skin to treat pain.
(b) Classification. Class II (performance standard
