GYROGEAR LIMITED · 89-08 · UNITED KINGDOM

For GYROGEAR LIMITED, import alert is 89-08; country is UNITED KINGDOM; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; product is GyroGlove (All sizes) | GyroGlove Dual Battery and Dual Harness (All sizes) | GyroGlove (All sizes) | GyroGlove Dual Battery and Dual Harness (All sizes) | GyroGlove (All sizes) | GyroGlove Dual Battery and Dual Harness (All sizes) | GyroGlove (All sizes) | GyroGlove Dual Battery and Dual Harness (All sizes) | GyroGlove (All sizes) | GyroGlove Dual Battery and Dual Harness (All sizes); product code is 84 M - - VV Device, Acupressure | 84 M - - VV Device, Acupressure | 84 Q - - BC External upper limb tremor stimulator | 84 Q - - BC External upper limb tremor stimulator | 87 O - - SE Patient specific manual navigation system | 87 O - - SE Patient specific manual navigation system | 89 K - - FT Assembly, Shoulder/Elbow/Forearm/Wrist/Hand, Mechanical | 89 K - - FT Assembly, Shoulder/Elbow/Forearm/Wrist/Hand, Mechanical | 89 K - - GH Unit, Wrist, External Limb Component, Powered | 89 K - - GH Unit, Wrist, External Limb Component, Powered; date published is 09/15/2025; address is 90a High Street , Berkhamsted, Hertfordshire UNITED KINGDOM, verified against its source on 2026-09-30.

What the source says

GYROGEAR LIMITED Date Published : 09/15/2025 90a High Street , Berkhamsted, Hertfordshire UNITED KINGDOM

— accessdata.fda.gov, retrieved 2026-09-22

Where each value comes from

The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.

— all from accessdata.fda.gov, retrieved 2026-09-22

Source

• accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified against source: 2026-09-30. Due for re-check by 2026-11-29. This page as Markdown · OKF bundle · full dataset as JSON.