# K062439: Powertone, Model PT-11

- Pathway: 510(k) (Traditional)
- Applicant: Johari Digital Healthcare, Ltd.
- Decided: Jan 8, 2007 after 140 days
- Product code: NGX (Stimulator, Muscle, Powered, For Muscle Conditioning)
- Device class: 2
- Regulation: 21 CFR 890.5850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
36 later devices descend from it; 1 cites it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Slendertone Flex BT: named in the summary without a submission number
- (no number) Slendertone Flex Max: named in the summary without a submission number

## Most influential descendants
- K131291: Torc Body (2013), 35 descendants of its own
- K163165: AM-100 (2017), 23 descendants of its own
- K180813: BTL 799-2 (2018), 21 descendants of its own
- K182106: BTL 799-2T (2018), 12 descendants of its own
- K190456: BTL 799-2L (2019), 11 descendants of its own

## Indications for use
POWERTONE PT-11 is intended to be used for: * Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of a firmer abdomen. * Strengthening, toning and firming of buttocks & thigh

Source page: https://510kreport.com/device/K062439
Methodology: https://510kreport.com/methodology