Bretherton Therapy Products · 89-08 · UNITED KINGDOM
For Bretherton Therapy Products, 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 Lipodren Muscle Stimulator | Lipodren Muscle Stimulator | Lipodren Muscle Stimulator | Lipodren Muscle Stimulator; product code is 84 N - - FO Stimulator, Transcutaneous Electrical, for Cosmetic Use | 87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep | 89 I - - PF Stimulator, Muscle, Powered | 89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning; date published is 09/16/2009; address is 29 Orchard Road , Sandy, Bedfordshire UNITED KINGDOM, verified against its source on 2026-09-30.
- Firm
- Bretherton Therapy Products 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
- 29 Orchard Road , Sandy, Bedfordshire UNITED KINGDOM verified
- Date published
- 09/16/2009 verified
- Product code
- 84 N - - FO Stimulator, Transcutaneous Electrical, for Cosmetic Use | 87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep | 89 I - - PF Stimulator, Muscle, Powered | 89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning each item verified
- Product
- Lipodren Muscle Stimulator | Lipodren Muscle Stimulator | Lipodren Muscle Stimulator | Lipodren Muscle Stimulator each item verified
- FDA notes
- DWPE Date 7/20/2005 | DWPE Date 7/20/2005 | DWPE Date 7/20/2005 | DWPE Date 7/20/2005 each item verified
What the source says
Bretherton Therapy Products Date Published : 09/16/2009 29 Orchard Road , Sandy, Bedfordshire UNITED KINGDOM
— accessdata.fda.gov, retrieved 2026-09-15
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.
Product code, Product and FDA notes
84 N - - FO Stimulator, Transcutaneous Electrical, for Cosmetic Use Date Published: 08/25/2023 Desc: Lipodren Muscle Stimulator Notes: DWPE Date 7/20/2005 87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep Date Published: 08/25/2023 Desc: Lipodren Muscle Stimulator Notes: DWPE Date 7/20/2005 89 I - - PF Stimulator, Muscle, Powered Date Published: 08/25/2023 Desc: Lipodren Muscle Stimulator Notes: DWPE Date 7/20/2005 89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning Date Published: 08/25/2023 Desc: Lipodren Muscle Stimulator Notes: DWPE Date 7/20/2005
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html