Health Technology (Pty) Ltd · 89-08 · SOUTH AFRICA
For Health Technology (Pty) Ltd · 89-08 · SOUTH AFRICA, 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 SOUTH AFRICA; 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 2026-09-16.
- 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 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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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