GYROGEAR LIMITED · 89-08 · UNITED KINGDOM
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
- 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
- Address
- 90a High Street , Berkhamsted, Hertfordshire UNITED KINGDOM verified
- Date published
- 09/15/2025 verified
- 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 each item verified
- 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) each item verified
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)
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html