The Signature Series, Imc IV

FDA 510(k) K933194 · Progressive Electrical Therapeutics

Substantially Equivalent

510(k) numberK933194

Submission

Device name
The Signature Series, Imc IV
Applicant
Progressive Electrical Therapeutics
Nevada, MO, US
Received
July 1, 1993
Decision date
July 13, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
IPF – Stimulator, Muscle, Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5850
Specialty
Physical Medicine

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More from Sunmed, LLC

510(k)DeviceDecision
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K943975Euro Tech Platinum Chiropractic TableINW · Traditional 09/29/1994SE
K943974Euro Tech Marquise Chiropractic TableINW · Traditional 09/29/1994SE
K943973Euro Tech Sterling Roller TableJFB · Traditional 09/29/1994SE
K933196The Signature Series, Ic IIIPF · Traditional 07/12/1994SE
K934919The Signature Series, Magnum 100IPF · Traditional 04/06/1994SE
K933195The Signature Series, Ic IVIPF · Traditional 02/23/1994SN
K914394Back MasterBXB · Traditional 11/13/1991SE

Questions and answers

When was The Signature Series, Imc IV cleared by the FDA?

The Signature Series, Imc IV (K933194) received a 510(k) decision of Substantially Equivalent on July 13, 1994, 377 days after the submission was received.

What is the product code of K933194?

The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.