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510(k) K882090

HIP SAVER by Pride Health Care, Inc. — Product Code INN

K882090 is an FDA 510(k) premarket notification submitted by Pride Health Care, Inc. for the device "HIP SAVER". The FDA issued a decision of Substantially Equivalent on May 26, 1988. The device falls under product code INN (Chair, Adjustable, Mechanical), a Class I device regulated under 21 CFR 890.3100. Pride Health Care, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1988
Date Received
May 19, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chair, Adjustable, Mechanical
Device Class
Class I
Regulation Number
890.3100
Review Panel
PM
Submission Type

Other clearances by Pride Health Care, Inc.

  • K945936 — JAZZY (May 28, 1996)
  • K944940 — EURO SC500 (February 12, 1996)
  • K953342 — TMR48 (September 8, 1995)
  • K944277 — DYNAMO (December 28, 1994)
  • K944939 — CELEBRITY XL SC445 (November 7, 1994)
  • K931231 — SIDEKICK II (May 5, 1994)
  • K930953 — CELEBRITY SC440 (March 28, 1994)
  • K926499 — SHUTTLE SC-140 (March 28, 1994)
  • K926296 — CELEBRITY SC400 (March 28, 1994)
  • K926295 — LEGEND SC 300 (March 28, 1994)

Other clearances for product code INN

  • K945650 — SPIFFY (December 19, 1994)
  • K942397 — THERADAPT HIGHCHAIR/STROLLER INSERT (June 22, 1994)
  • K930520 — THERADAPT(R) ADJUSTABLE CLASSROOM CHAIR (March 24, 1993)
  • K923750 — ABLE GENERATION BOOSTER CHAIR (January 29, 1993)
  • K923752 — ABLE GENERATION PLAY CHAIR (January 29, 1993)
  • K923753 — ABLE GENERATION THERAPY TILT BENCH (January 29, 1993)
  • K923095 — KAYE MODEL KIAO PELVIC/THIGH STABILIZER (July 21, 1992)
  • K922061 — CHAIR, ADJUSTABLE, MECHANICAL (May 26, 1992)
  • K921272 — ACTIVITY CHAIR (April 7, 1992)
  • K904069 — BRODA NURSING CARE CHAIR (September 17, 1990)

FDA data resources