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Golden State Medical HD Combo

International Trade Group Inc · Model ECS322P · UDI-DI 00860001588309

NGXNUH Prescription
10
510(k) clearances
99
Adverse events
3
Recalls
212
Facilities

Description

GSM HD Combo Transcutaneous Electrical Nerve Stimulation (TENS): The device is intended for the temporary relief of pain associated with sore and aching muscles in the lower back, upper extremities (arms) and lower extremities (legs) due to strain from exercise and/or normal household and work activities. GSM HD Combo Neuromuscular electrical stimulation (NMES): The device is intended to stimulate muscles in order to facilitate and improve muscle performance.

Recalls

DateFirmReason
2021-01-13BEMER INT. AGThere potential that electromagnetic fields generated in the therapy system may cause technical defects in a patient using an insulin pumps or a malfunction of a pacemaker.
2013-05-23Pinook-UsaFailure to submit a premarket submission and gain approval of a medical device.
2013-05-23Pinook-UsaFailure to submit a premarket submission and gain approval of a medical device.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.