# K061828: Lorenz Biotech Aptiva, Version 2.13

- Pathway: 510(k) (Traditional)
- Applicant: Lorenz Biotech S.P.A.
- Decided: Aug 24, 2007 after 422 days
- Product code: GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief)
- Device class: 2
- Regulation: 21 CFR 882.5890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K892649 (1989). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021755: Apex Medical Digital Tens TS1211, TS1212, Apex Medical Corp. (2002) Summary page 1.
- K032994: GM3 Series HV Tens, Model GM3X3HV (Where X IS Parameter of Different Housing), Gemore Technology Co, Ltd. (2003) Summary page 1.
- K970429: Bioscope SD Tens, Arista SD Plus, AP-102080T, Apex Medical Corp. (1997). Our reading of the summary gave K970249, FDA’s number for Simplex Airbrator (Simplex Medical Systems, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Bioscope SD TENS”.
- K022405: Modification to Promax-XP, Tens and Microcurrent Device; Promax-Tens, Tens Device; Promax-Libra, Tens Device; Promax-Mic, Rehabilicare, Inc. (2002) Summary page 1.
- K003433: Neuro-Train Iii (3), Sterne Equipment Co., Ltd. (2001) Summary page 1.
- K972487: Emg Retrainer, Chattanooga Group, Inc. (1997) Summary page 1.
- K013399: Model Mes-9000/Emg System, Myotronics-Noromed, Inc. (2001) Summary page 1.
- K981405: Synergy LT, Oxford Instruments, Plc. (1998) Summary page 1.
- K012069: Modification to:Brevio Nerve Conduction Test Instrument, Neurotron Medical, Inc. (2001). Our reading of the summary gave K010269, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Brevio”.

## Indications for use
The Aptiva TM v2.13U is a multifunctional transcutaneous electrical nerve stimulator (TENS) equipped with a surface electromyography and electroneurography. Aptiva TM is indicated for symptomatic relief and management of chronic pain, intractable pain and/or as an adjunctive treatment for the management of post-traumatic pain. The dynamic surface electromyography and electroneurography system is used for biofeedback, relaxation training, and muscle re-education as well as monitoring and display of bioelectric signals produced by muscles, stimulate peripheral nerves, and monitor and display the electrical activity produced by nerves.

Source page: https://510kreport.com/device/K061828
Methodology: https://510kreport.com/methodology