Recall Z-2932-2020— Stimwave Technologies Inc
Class II · Ongoing
Class II FDA medical device recall by Stimwave Technologies Inc, initiated 2020-07-15. It names 2 FDA 510(k) clearances: K171366, K152178. Product: StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.. Reason: The product contains a non-functional component not referenced in product labeling..
- Recalling firm
- Stimwave Technologies Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2020-07-15
- Firm location
- Pompano Beach, FL, United States
510(k) clearances named in this recall
2 on FDA's record- K171366 — Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit
- K152178 — StimQ Peripheral Nerve Stimulator (PNS) System
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.
Reason for recall
The product contains a non-functional component not referenced in product labeling.
Data sourced from openFDA. This site is unofficial and independent of the FDA.