# GYROGEAR LIMITED · 89-08 · UNITED KINGDOM — FDA import alert red lists: firms subject to detention without physical examination

For GYROGEAR LIMITED · 89-08 · UNITED KINGDOM, import alert is 89-08; 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)"; country is UNITED KINGDOM; product is GyroGlove (All sizes) | GyroGlove Dual Battery and Dual Harness (All sizes) | GyroGlove Dual Battery and Dual Harness (All sizes) | GyroGlove (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 Dual Battery and Dual Harness (All sizes) | GyroGlove (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 2026-09-16.

- **Firm:** GYROGEAR LIMITED _(verified: appears in the quote below)_
- **Import alert:** 89-08
- **Import alert name:** "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- **Country:** UNITED KINGDOM _(verified: appears in the quote below)_
- **Address:** 90a High Street , Berkhamsted, Hertfordshire UNITED KINGDOM _(verified: appears in the quote below)_
- **Date published:** 09/15/2025 _(verified: appears in the quote below)_
- **Product code:** 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 _(verified: each item appears in the quote below)_
- **Product:** GyroGlove (All sizes) | GyroGlove Dual Battery and Dual Harness (All sizes) | GyroGlove Dual Battery and Dual Harness (All sizes) | GyroGlove (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 Dual Battery and Dual Harness (All sizes) | GyroGlove (All sizes) _(verified: each item appears in the quote below)_

## What the source says

> GYROGEAR LIMITED Date Published : 09/15/2025 90a High Street , Berkhamsted, Hertfordshire UNITED KINGDOM 84 M - - VV Device, Acupressure Date Published: 09/15/2025 Desc: GyroGlove (All sizes) 84 M - - VV Device, Acupressure Date Published: 09/15/2025 Desc: GyroGlove Dual Battery and Dual Harness (All sizes) 84 Q - - BC External upper limb tremor stimulator Date Published: 09/15/2025 Desc: GyroGlove Dual Battery and Dual Harness (All sizes) 84 Q - - BC External upper limb tremor stimulator Date Published: 09/15/2025 Desc: GyroGlove (All sizes) 87 O - - SE Patient specific manual navigation system Date Published: 09/15/2025 Desc: GyroGlove (All sizes) 87 O - - SE Patient specific manual navigation system Date Published: 09/15/2025 Desc: GyroGlove Dual Battery and Dual Harness (All sizes) 89 K - - FT Assembly, Shoulder/Elbow/Forearm/Wrist/Hand, Mechanical Date Published: 09/15/2025 Desc: GyroGlove (All sizes) 89 K - - FT Assembly, Shoulder/Elbow/Forearm/Wrist/Hand, Mechanical Date Published: 09/15/2025 Desc: GyroGlove Dual Battery and Dual Harness (All sizes) 89 K - - GH Unit, Wrist, External Limb Component, Powered Date Published: 09/15/2025 Desc: GyroGlove Dual Battery and Dual Harness (All sizes) 89 K - - GH Unit, Wrist, External Limb Component, Powered Date Published: 09/15/2025 Desc: GyroGlove (All sizes)

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).