In 2002 the FDA approved the Actiband which was renamed ActiPatch. Please see approval letter below.
Mr. Andrew J. WhelanPresidentPAW, LLC
5540 Hidden Waters LaneFrederick, Maryland 2 1703Re: KO22404Trade/Device Name: Actiband’”
Regulation Number: 21 CFR §890.5300(b)
Regulation Name: Ultrasonic diathermy for use other than applying therapeutic deepheat
Regulatory Class: I11
Product Code: ILXDated: July 19, 2002
Received: July 23, 2002
Dear Mr. Whelan:
We have reviewed your Section 5 10(k) preniarket notification of intent to market the devicereferenced above and have determined the device is substantially equivalent (for the indicationsfor use stated in the enclosure) to legally marketed predicate devices marketed in interstatecommerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or todevices that have been reclassified in accordance with the provisions of the Federal Food, Drug,and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).You may, therefore, market the device, subject to the general controls provisions of the Act.
In 2008 the FDA approved a similar designed portable PEMF device, the Soft Pulse Torino II.
Date Prepared: December 9, 2008
Trade Name: Ivivi SofPulse: Models 912-M1b, Roma 3 and Torino 1I
Common Name: Shortwave Diathermy
Classification Name: Shortwave diathermy for all other uses (per 21 CFR Section890.5290(b));
Product Code ILX (Diathermy, shortwave, for use otherthan applying therapeutic deep heat)
Manufacturer's Name:, IVIVLJECHNOLOGIES, INC.
Address:224-S Pegasus AvenueNorthvale, New Jersey 07647
Corresponding Official: Mr. Andr6 DiMino
Title:Executive VP Telephone:201-767-6040Fax:201-784-0620
Predicate Device: MRT (K903675),
Product Code: ILX (per 21 CFR Section 890.5290(b))
Device Descrigtion: SofPulse (91 2-M1b, Roma 3 and Torino 11) devices are shortwavediathermy medical devices which apply to the body electromagnetic energy at a radiofrequency (RF) of 27.12 MHz for the treatment of medical conditions by means other than thegeneration of deep heat within body tissues, i.e., by athermal means. The SofPulse modelswere designed to deposit mean radio frequency energy in tissue which is equivalent to that ofthe predicate MRT device. All of the SofPulse options deliver the RIF signal to the tissuetarget via inductive coupling with an applicator coil. SofPulse devices are portable andtreatment can occur directly through dressings, clothing, casts, compression garments orsupports.Intended Use/indications For Use: Adjunctive use in the palliative treatment of postoperativepain and edema in superficial soft tissue.
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