# K102278: Quadra Bloc Tens Plus

- Pathway: 510(k) (Traditional)
- Applicant: Gradient Technologies, LLC
- Decided: Oct 20, 2011 after 435 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: 7 generations back to K001179 (2000). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062547: Quadra Bloc Tens, Model 101, Gradient Technologies, LLC (2007) Summary page 1.
- K083202: Combocare 2000, Xanacare Technologies, LLC (2008) Summary page 1.
- K070807: Cutaneous Electrotherapy and Recording Electrodes; Tens Electrodes, Pepin Mfg., Inc. (2007) Summary page 1.

## Indications for use
The QuadraBloc TENS Model 101 is intended for use in relief of chronic intractable pain and adjunctive treatment of post-surgical or post-traumatic acute pain. This is a prescription device and should be used under continued medical supervision.

Source page: https://510kreport.com/device/K102278
Methodology: https://510kreport.com/methodology