Microtens 7757 T.E.N.S. Stimulator

FDA 510(k) K844017 · Rabar, Inc.

Substantially Equivalent

510(k) numberK844017

Submission

Device name
Microtens 7757 T.E.N.S. Stimulator
Applicant
Rabar, Inc.
Rochester, NY, US
Received
October 15, 1984
Decision date
November 30, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GFJ – Mallet, Surgical, General & Plastic Surgery
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Specialty
General, Plastic Surgery

Other 510(k)s with product code GFJ

510(k)DeviceApplicantDecision
K85178929-200 to 29-230 Various Bone Mallets(Wihiger, DoyGFJ · Traditional Artiberia06/20/1985SE
K822204ENT MalletsGFJ · Traditional Kelleher Corp.09/17/1982SE

More from Kelleher Corp.

510(k)DeviceDecision
K842414Echo Pulse BurstGZJ · Traditional 07/27/1984SE
K821736Echo-Pulse KM555GXW · Traditional 12/09/1982SE

Questions and answers

When was Microtens 7757 T.E.N.S. Stimulator cleared by the FDA?

Microtens 7757 T.E.N.S. Stimulator (K844017) received a 510(k) decision of Substantially Equivalent on November 30, 1984, 46 days after the submission was received.

What is the product code of K844017?

The FDA product code is GFJ – Mallet, Surgical, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.