Cleared Traditional

K895211 - TTS2700 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR
(FDA 510(k) Clearance)

K895211 · Henley Intl. · Neurology

Oct 1989

Decision

73d

Days

Class 2

Risk

K895211 is an FDA 510(k) clearance for the TTS2700 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II — Special Controls, product code GZJ), submitted by Henley Intl. (Sugar Land, US). The FDA issued a Cleared decision on October 30, 1989, 73 days after receiving the submission on August 18, 1989. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K895211 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 18, 1989
Decision Date	October 30, 1989
Days to Decision	73 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	—