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510(k) K242940

Xrecovery (XR-001) by Shenzhen Xinrun Electric Appliances Co, Ltd. — Product Code IRP

K242940 is an FDA 510(k) premarket notification submitted by Shenzhen Xinrun Electric Appliances Co, Ltd. for the device "Xrecovery (XR-001)". The FDA issued a decision of Substantially Equivalent on November 14, 2024. The device falls under product code IRP (Massager, Powered Inflatable Tube), a Class II device regulated under 21 CFR 890.5650.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2024
Date Received
September 25, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Massager, Powered Inflatable Tube
Device Class
Class II
Regulation Number
890.5650
Review Panel
PM
Submission Type

Other clearances for product code IRP

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  • K253064 — Air Pressure Therapy System (VU-IPC8M); Air Pressure Therapy System (VU-IPC6M); (April 30, 2026)
  • K252386 — Hot and Cold Compression System (A02-C-032) (April 3, 2026)
  • K253076 — Cryopush Cold Compression Device (A02-P-001) (April 2, 2026)
  • K251622 — Hand Massager (SM004D) (January 28, 2026)
  • K251662 — Air Compression Therapy Device (ST-504); Air Compression Therapy Device (ST-505) (November 13, 2025)
  • K251531 — AIR COMPRESSION BOOTS 1018195,1018196 (October 30, 2025)
  • K253150 — Cryon-X Cold Compression (October 24, 2025)

FDA data resources