Data / Medical devices / United States / Smart Recovery Technologies LLC
Smart Recovery Technologies LLC: FDA-registered device maker in Quakertown, PA, United States, 5 510(k) clearances
Smart Recovery Technologies LLC is registered with the FDA (registration 3012176966) in Quakertown, PA, United States. It lists 6 device types. The FDA files 5 510(k) clearances under its listings, the newest dated January 19, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012176966
- Address
- 2070 angstadt road, Quakertown, PA, United States, 18951
- Owner or operator
- Smart Recovery Technologies Llc (10082736)
- Roles
- Repackager or relabeler
- First device listed
- October 3, 2023
- Registered through
- 2026
- Brand names listed
- Smart Ice, Smart Pad, Smart Stim; Transcutaneous Electrical Nerve Stimulator Model KTR -2492, Smart-DVT, Smart-Wave: Transcutaneous and ESTIM, Triad 3LT
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Cutaneous | GXY | 2 | Repackager or relabeler | accessdata.fda.gov |
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Repackager or relabeler | accessdata.fda.gov |
| Massager, Powered Inflatable Tube | IRP | 2 | Repackager or relabeler | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | Repackager or relabeler | accessdata.fda.gov |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 19, 2024 | K230524 | Cold Compression Wrap Pro | IRP | Substantially Equivalent | Chengdu Cryo-Push Medical Technology Co.,Ltd | accessdata.fda.gov |
| March 24, 2023 | K221589 | Starly pad | GXY | Substantially Equivalent | Shenzhen Xingyuanli Technology Co., Ltd. | accessdata.fda.gov |
| November 23, 2021 | K212169 | Air compression therapy system FO3002 | IRP | Substantially Equivalent | Foshan Hongfeng Co., Ltd. | accessdata.fda.gov |
| March 25, 2021 | K200177 | Low-frequency Multi-function physiotherapy instrument | NUH | Substantially Equivalent | Shenzhen Kentro Medical Electronics Co., Ltd. | accessdata.fda.gov |
| October 19, 2020 | K200237 | Transcutaneous Electronic Nerve Stimulator | NUH | Substantially Equivalent | Shenzhen Kentro Medical Electronics Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Massager, Powered Inflatable Tube
- All makers of Pack, Hot Or Cold, Reusable
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Electrode, Cutaneous
- All makers of Stimulator, Nerve, Transcutaneous, Over-The-Counter
- All makers of Stimulator, Muscle, Powered, For Muscle Conditioning
Updated January 19, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.