# K091236: Mantra Combo, Model Mecs 320

- Pathway: 510(k) (Traditional)
- Applicant: Mantra Intl. (Hk), Ltd.
- Decided: Jul 30, 2009 after 94 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: 3 generations back to K840346 (1984). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041520: Mantra Tens Model NT3, Mantra Intl. (Hk), Ltd. (2004) Summary page 2.
- K021905: Classic NMS, Care Rehab, Inc. (2002) Summary page 2.

## Indications for use
a. TENS: The device is intended for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post traumatic acute pain. b. NMS: The device is recommended for use for the following conditions: 1. Relaxation of muscle spasms 2. Prevention of retardation of disuse atrophy 3. Increasing local blood circulation 4. Muscle re-education 5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis 6. Maintaining and increasing range of motion.

Source page: https://510kreport.com/device/K091236
Methodology: https://510kreport.com/methodology