← FDA Medical Device Classifications

Stimulator, Nerve, Transcutaneous, For Pain Relief

GZJ · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.5890

Classification

FDA Product Code
GZJ
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 882.5890
Review panel
NE
Medical specialty
Neurology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y

Market data

Cleared 510(k) submissions
605
Registered establishments
180

Source

Authoritative
FDA Device Classification database
Machine
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