RecoveryRx

Q: When was RecoveryRx cleared by the FDA?

RecoveryRx (K190251) received a 510(k) decision of Substantially Equivalent on June 28, 2019, 141 days after the submission was received.

Q: What is the product code of K190251?

The FDA product code is ILX – Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat, a Class II (moderate risk) device regulated under 21 CFR 890.5290.

FDA 510(k) K190251 · Bioelectronics Corporation

Substantially Equivalent

510(k) numberK190251

Submission

Device name: RecoveryRx
Applicant: Bioelectronics Corporation
Frederick, MD, US
Received: February 7, 2019
Decision date: June 28, 2019
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: ILX – Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
Device class: Class II (moderate risk)
Regulation: 21 CFR 890.5290
Specialty: Physical Medicine

Other 510(k)s with product code ILX

510(k)	Device	Applicant	Decision
K241395	Active System; Avenue8ILX · Traditional	Caerus Corporation	12/18/2024SE
K202337	Pulsed electromagnetic field wrapILX · Traditional	Hi-Dow International, Inc.	12/15/2020SE
K131979	Provant Therapy SystemILX · Traditional	Regenesis Biomedical, Inc.	12/13/2013SE
K121702	Orthocor Active Device Orthocor General Use Active DeviceILX · Traditional	Orthocor Medical	05/06/2013SE
K121338	ZeobiILX · Special	Ivivi Health Science, LLC	07/27/2012SE
K091791	Provant System, Model 4201ILX · Traditional	Regenesis Biomedical, Inc.	04/07/2010SE
K092044	Orthocor Knee System, Median, Large, X-LargeILX · Traditional	Orthocor Medical	12/18/2009SE
K091996	Orthocor Knee System BasicILX · Traditional	Orthocor Medical	12/15/2009SE
K070541	Ivivi Sofpulse, Models 912-M10, ROMA3 and Torino IIILX · Traditional	Ivivi Technologies, Inc.	12/11/2008SE
K070931	Model PMT850ILX · Traditional	Promedtek, Inc.	05/24/2007SE

More from Promedtek, Inc.

510(k)	Device	Decision
K192234	ActiPatchPQY · Traditional	01/31/2020SE
K152432	ActiPatch(R)PQY · Traditional	02/03/2017SE

Questions and answers

When was RecoveryRx cleared by the FDA?

RecoveryRx (K190251) received a 510(k) decision of Substantially Equivalent on June 28, 2019, 141 days after the submission was received.

What is the product code of K190251?

The FDA product code is ILX – Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat, a Class II (moderate risk) device regulated under 21 CFR 890.5290.