# K160255: HBOTC Muscle and Nerve Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Hb Medical, Inc.
- Decided: Sep 15, 2016 after 227 days
- Product code: NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter)
- 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: 6 generations back to K940301 (1994). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131910: MPP, Marc Pro (2014) Summary page 4.
- K112485: H-WAVE, Electronic Waveform Lab, Inc. (2011) Summary page 4.
- K103738: H-WAVE, Electronic Waveform Laboratory, Inc. (2011) Summary page 4.
- K102051: Pain Buddy, Biomedical Life Systems, Inc. (2011) Summary page 4.

## Indications for use
Transcutaneous Electrical Nerve Stimulation: 1. For symptomatic relief and management of chronic pain 2. For adjunctive treatment in the management of post-surgical and post-traumatic pain 3. For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise and normal household and work activities Powered Muscle Stimulator 1. To temporarily increase local blood circulation in healthy muscles 2. For muscle conditioning by stimulating healthy muscle in order to improve or facilitate muscle performance

Source page: https://510kreport.com/device/K160255
Methodology: https://510kreport.com/methodology