Product Code: NHH
FDA class 2
21 CFR 890.5500
Device, Discharge, Electrostatic (For Pain Relief)
Physical Medicine
The Device, Discharge, Electrostatic (For Pain Relief) (product code NHH) is a physical medicine device that applies electrostatic or coronal discharge to the body surface for pain relief, as described in its definition. It is classified as an FDA Class 2 device within the Physical Medicine specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. The device is not flagged as an implant or life-sustaining device.
510(k)s
2
FEI Numbers
0
Registration Numbers
0
Unique Applicants
2
Years Active
4
Basic Information
- Product Code
- NHH
- Device Class
- FDA class 2
- Regulation Number
- 890.5500
- Medical Specialty
- Physical Medicine
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
Definition
An electrostatic discharge device which applies an electrostatic or coronal discharge to or near a person's skin for the symptomatic relief of pain
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.