Health Technology (Pty) Ltd · 89-08 · SOUTH AFRICA
For Health Technology (Pty) Ltd, import alert is 89-08; country is SOUTH AFRICA; 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 Lamp; Infrared; Therapeutic Heating | Stimulator; Muscle; Powdered; For Muscle Conditioning; product code is 89 I - - LY Lamp, infrared, therapeutic heating | 89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning; date published is 04/02/2014; address is Unit 3, 6 Palmfield Road , Springfield Park, SOUTH AFRICA, verified against its source on 2026-09-30.
- Firm
- Health Technology (Pty) Ltd 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
- SOUTH AFRICA verified
- Address
- Unit 3, 6 Palmfield Road , Springfield Park, SOUTH AFRICA verified
- Date published
- 04/02/2014 verified
- Product code
- 89 I - - LY Lamp, infrared, therapeutic heating | 89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning each item verified
- Product
- Lamp; Infrared; Therapeutic Heating | Stimulator; Muscle; Powdered; For Muscle Conditioning each item verified
- FDA notes
- class II Distributor: Esparron Limited, FEI #3008028431 | class II Distributor: Esparron Limited, FEI #3008028431 each item verified
What the source says
Health Technology (Pty) Ltd Date Published : 04/02/2014 Unit 3, 6 Palmfield Road , Springfield Park, SOUTH AFRICA
— 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
89 I - - LY Lamp, infrared, therapeutic heating Date Published: 04/02/2014 Desc: Lamp; Infrared; Therapeutic Heating Notes: class II Distributor: Esparron Limited, FEI #3008028431 89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning Date Published: 04/02/2014 Desc: Stimulator; Muscle; Powdered; For Muscle Conditioning Notes: class II Distributor: Esparron Limited, FEI #3008028431
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html