Data / Medical devices / United States / JK Products & Services, Inc.
JK Products & Services, Inc.: FDA-registered device maker in Jonesboro, AR, United States, 5 510(k) clearances
JK Products & Services, Inc. is registered with the FDA (registration 2311923) in Jonesboro, AR, United States. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated May 10, 2019. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2311923
- Address
- 1823 Grant Ave Ste A, Jonesboro, AR, United States, 72401
- Owner or operator
- JK Products & Services (2311923)
- Roles
- Complaint file establishment
- First device listed
- December 8, 2010
- Registered through
- 2026
- Brand names listed
- Beauty Angel, Beauty Angel 7200, ESSENCE VIBRA SHAPE, Elements by Planet Fitness, Elements by Wellsystem, Ergoline / Passion 34 Super Power(15 min), Ergoline / Passion 34 Super Power(20 min), Ergoline Inspiration 550 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Booth, Sun Tan | LEJ | 2 | Complaint file establishment | accessdata.fda.gov |
| Exerciser, Powered | BXB | 1 | Complaint file establishment | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 10, 2019 | K190173 | Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound | LEJ | Substantially Equivalent | Jk-Holding GmbH | accessdata.fda.gov |
| April 8, 2019 | K183539 | Ergoline Sunrise 7200 Hybrid Technology | LEJ | Substantially Equivalent | Jk-Holding GmbH | accessdata.fda.gov |
| October 11, 2018 | K180555 | Ergoline Prestige 1600 Hybrid Performance | LEJ | Substantially Equivalent | Jk Holding GmbH | accessdata.fda.gov |
| February 14, 2018 | K173565 | Sunrise 6200, Sunrise 7200 | LEJ | Substantially Equivalent | Jk-Holding GmbH | accessdata.fda.gov |
| September 16, 2015 | K151400 | Ergoline, Sun Angel, Soltron, Sundash and Palm Beach Tan Sunlamp Products | LEJ | Substantially Equivalent | Jk Holding GmbH | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 25, 2014 | 69038 | Class II | Terminated | SUN DASH RADIUS 252 PN 8000809705. The device is intended to be used for the tanning of human skin. | The integrity of the wires inside main electrical chord become compromised from excessive flexing (during the door open/close process). | accessdata.fda.gov |
| May 7, 2012 | 61855 | Class II | Terminated | BeautyAngel Health Fitness Natural Collagen Stimulation Anti Aging For human use. | The Beauty Angel was marketed without a 510k. | accessdata.fda.gov |
| July 8, 2005 | 61869 | Class II | Terminated | SUN|DASH RADIUS 252 tanning system; 52 lamps, Ultraviolet Radiation. The device is intended to be used for tanning of the human skin. | The firm has tracked a systematic failure in the door cord on the Sun|Dash Radius 252 product line. In some instances when the door cord is installed with little or no slack outside the upper decor piece, the cord has been known to fail causing a short in the wiring at the pivot point in the cord. | accessdata.fda.gov |
Compare with other makers
- All makers of Booth, Sun Tan
- All makers of Exerciser, Powered
- All makers of Massager, Therapeutic, Electric
Updated May 10, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.